Effects of a Guided Web-Based Smoking Cessation Program With Telephone Counseling: A Cluster Randomized Controlled Trial

Background

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners.

Objective

Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting.

Methods

The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks.

Results

We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080).

Conclusions

This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome.

Trial Registration

German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).     

Effectiveness of a Web-Based,Computer-Tailored,Pedometer-Based Physical Activity Intervention for Adults: A Cluster Randomized Controlled Trial

Background

Computer-tailored physical activity (PA) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level. However, personalized advice is mostly provided based on subjectively measured PA, which is not very accurate and might result in the delivery of advice that is not credible or effective. Therefore, an innovative computer-tailored PA advice was developed, based on objectively pedometer-measured PA.

Objective

The study aim was to evaluate the effectiveness of a computer-tailored, pedometer-based PA intervention in working adults.

Methods

Participants (≥18 years) were recruited between May and December 2012 from eight Flemish workplaces. These workplaces were allocated randomly to an intervention or control group. Intervention group participants (n=137) received (1) a booklet with information on how to increase their steps, (2) a non-blinded pedometer, and (3) an Internet link to request computer-tailored step advice. Control group participants (n=137) did not receive any of the intervention components. Self-reported and pedometer-based PA were assessed at baseline (T0), and 1 month (T1) and 3 months (T2) months post baseline. Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample (ie, adults not reaching 10,000 steps a day at baseline).

Results

The recruitment process resulted in 274 respondents (response rate of 15.1%) who agreed to participate, of whom 190 (69.3%) belonged to the at-risk sample. Between T0 and T1 (1-month post baseline), significant intervention effects were found for participants’ daily step counts in both the total sample (P=.004) and the at-risk sample (P=.001). In the at-risk sample, the intervention effects showed a daily step count increase of 1056 steps in the intervention group, compared to a decrease of 258 steps in the control group. Comparison of participants’ self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants’ daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant.

Conclusions

A computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy).     

Effectiveness of a Web-Based Physical Activity Intervention in Patients With Knee and/or Hip Osteoarthritis: Randomized Controlled Trial

Background

Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled “Join2move”. The Join2move intervention is a self-paced 9-week PA program in which the patient’s favorite recreational activity is gradually increased in a time-contingent way.

Objective

The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group.

Methods

The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control.

Results

Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and 75.4% (150/199) after 12 months. In this study, 94.0% (94/100) of participants actually started the program, and 46.0% (46/100) reached the adherence threshold of 6 out of 9 modules completed. At 3 months, participants in the intervention group reported a significantly improved physical function status (difference=6.5 points, 95% CI 1.8-11.2) and a positive self-perceived effect (OR 10.7, 95% CI 4.3-26.4) compared with the control group. No effect was found for self-reported PA. After 12 months, the intervention group showed higher levels of subjective (difference=21.2 points, 95% CI 3.6-38.9) and objective PA (difference=24 minutes, 95% CI 0.5-46.8) compared with the control group. After 12 months, no effect was found for physical function (difference=5 points, 95% CI −1.0 to 11.0) and self-perceived effect (OR 1.2, 95% CI 0.6-2.4). For several secondary endpoints, the intervention group demonstrated improvements in favor of the intervention group.

Conclusions

Join2move resulted in changes in the desired direction for several primary and secondary outcomes. Given the benefits and its self-help format, Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA.

Trial Registration

The Netherlands National Trial Register: NTR2483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2483 (Archived by WebCite at http://www.webcitation.org/67NqS6Beq).     

It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial

BackgroundPhysical inactivity is a major public health problem. The It’s LiFe! monitoring and feedback tool embedded in the Self-Management Support Program (SSP) is an attempt to stimulate physical activity in people with chronic obstructive pulmonary disease or type 2 diabetes treated in primary care.ObjectiveOur aim was to evaluate whether the SSP combined with the use of the monitoring and feedback tool leads to more physical activity compared to usual care and to evaluate the additional effect of using this tool on top of the SSP.MethodsThis was a three-armed cluster randomised controlled trial. Twenty four family practices were randomly assigned to one of three groups in which participants received the tool + SSP (group 1), the SSP (group 2), or care as usual (group 3). The primary outcome measure was minutes of physical activity per day. The secondary outcomes were general and exercise self-efficacy and quality of life. Outcomes were measured at baseline after the intervention (4-6 months), and 3 months thereafter.ResultsThe group that received the entire intervention (tool + SSP) showed more physical activity directly after the intervention than Group 3 (mean difference 11.73, 95% CI 6.21-17.25; P<.001), and Group 2 (mean difference 7.86, 95% CI 2.18-13.54; P=.003). Three months after the intervention, this effect was still present and significant (compared to Group 3: mean difference 10.59, 95% CI 4.94-16.25; P<.001; compared to Group 2: mean difference 9.41, 95% CI 3.70-15.11; P<.001). There was no significant difference in effect between Groups 2 and 3 on both time points. There was no interaction effect for disease type.ConclusionsThe combination of counseling with the tool proved an effective way to stimulate physical activity. Counseling without the tool was not effective. Future research about the cost-effectiveness and application under more tailored conditions and in other target groups is recommended.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01867970","term_id":"NCT01867970"}}NCT01867970, https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01867970","term_id":"NCT01867970"}}NCT01867970 (archived by WebCite at http://www.webcitation.org/6a2qR5BSr).     

Motivational Interviewing in a Web-Based Physical Activity Intervention With an Avatar: Randomized Controlled Trial

Background

Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based.

Objective

The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based.

Methods

A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention.

Results

Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta_{AVATARvsCONTROL}=.39, P=.011; beta_{TEXTvsCONTROL}=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone.

Conclusions

The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user’s state and input.

Trial Registration

Dutch Trial Register trial number: NTR3147; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3147 (Archived by WebCite at http://www.webcitation.org/6NCbwdUJX).     

Effects of a Web-Based Intervention for Stress Reduction in Primary Care: A Cluster Randomized Controlled Trial

Background

Preliminary findings suggest that Web-based interventions may be effective in achieving significant stress reduction. To date, there are no findings available for primary care patients. This is the first study that investigates a Web-based intervention for stress reduction in primary care.

Objective

The aim was to examine the short-term effectiveness of a fully automated Web-based coaching program regarding stress reduction in a primary care setting.

Methods

The study was an unblinded cluster randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily text message reminders, and weekly feedback through the Internet. All components of the program were fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was change in the Perceived Stress Questionnaire (PSQ) over 12 weeks.

Results

A total of 93 participants (40 in intervention group, 53 in control group) were recruited into the study. For 25 participants from the intervention group and 49 participants from the control group, PSQ scores at baseline and 12 weeks were available. In the intention-to-treat analysis, the PSQ score decreased by mean 8.2 (SD 12.7) in the intervention group and by mean 12.6 (SD 14.7) in the control group. There was no significant difference identified between the groups (mean difference –4.5, 95% CI –10.2 to 1.3, P=.13).

Conclusions

This trial could not show that the tested Web-based intervention was effective for reducing stress compared to usual care. The limited statistical power and the high dropout rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed with larger populations to investigate the long-term outcome as well as the contents of usual primary care.

Trial Registration

German Clinical Trials Register DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6eXk0PXmO)     

Effect of a Web-Based Intervention to Promote Physical Activity and Improve Health Among Physically Inactive Adults: A Population-Based Randomized Controlled Trial

Background

Many people in Western countries do not follow public health physical activity (PA) recommendations. Web-based interventions provide cost- and time-efficient means of delivering individually targeted lifestyle modification at a population level.

Objective

To examine whether access to a website with individually tailored feedback and suggestions on how to increase PA led to improved PA, anthropometrics, and health measurements.

Methods

Physically inactive adults (n = 12,287) participating in a nationwide eHealth survey and health examination in Denmark were randomly assigned to either an intervention (website) (n = 6055) or a no-intervention control group (n = 6232) in 2008. The intervention website was founded on the theories of stages of change and of planned behavior and, apart from a forum page where a physiotherapist answered questions about PA and training, was fully automated. After 3 and again after 6 months we emailed participants invitations to answer a Web-based follow-up questionnaire, which included the long version of the International Physical Activity Questionnaire. A subgroup of participants (n = 1190) were invited to a follow-up health examination at 3 months.

Results

Less than 22.0% (694/3156) of the participants logged on to the website once and only 7.0% (222/3159) logged on frequently. We found no difference in PA level between the website and control groups at 3- and 6-month follow-ups. By dividing participants into three groups according to use of the intervention website, we found a significant difference in total and leisure-time PA in the website group. The follow-up health examination showed no significant reductions in body mass index, waist circumference, body fat percentage, and blood pressure, or improvements in arm strength and aerobic fitness in the website group.

Conclusions

Based on our findings, we suggest that active users of a Web-based PA intervention can improve their level of PA. However, for unmotivated users, single-tailored feedback may be too brief. Future research should focus on developing more sophisticated interventions with the potential to reach both motivated and unmotivated sedentary individuals.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01295203","term_id":"NCT01295203"}}NCT01295203; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01295203","term_id":"NCT01295203"}}NCT01295203 (Archived by WebCite at http://www.webcitation.org/6B7HDMqiQ)     

Effects of a Web-Based Personalized Intervention on Physical Activity in European Adults: A Randomized Controlled Trial

BackgroundThe high prevalence of physical inactivity worldwide calls for innovative and more effective ways to promote physical activity (PA). There are limited objective data on the effectiveness of Web-based personalized feedback on increasing PA in adults.ObjectiveIt is hypothesized that providing personalized advice based on PA measured objectively alongside diet, phenotype, or genotype information would lead to larger and more sustained changes in PA, compared with nonpersonalized advice.MethodsA total of 1607 adults in seven European countries were randomized to either a control group (nonpersonalized advice, Level 0, L0) or to one of three personalized groups receiving personalized advice via the Internet based on current PA plus diet (Level 1, L1), PA plus diet and phenotype (Level 2, L2), or PA plus diet, phenotype, and genotype (Level 3, L3). PA was measured for 6 months using triaxial accelerometers, and self-reported using the Baecke questionnaire. Outcomes were objective and self-reported PA after 3 and 6 months.ResultsWhile 1270 participants (85.81% of 1480 actual starters) completed the 6-month trial, 1233 (83.31%) self-reported PA at both baseline and month 6, but only 730 (49.32%) had sufficient objective PA data at both time points. For the total cohort after 6 months, a greater improvement in self-reported total PA (P=.02) and PA during leisure (nonsport) (P=.03) was observed in personalized groups compared with the control group. For individuals advised to increase PA, we also observed greater improvements in those two self-reported indices (P=.006 and P=.008, respectively) with increased personalization of the advice (L2 and L3 vs L1). However, there were no significant differences in accelerometer results between personalized and control groups, and no significant effect of adding phenotypic or genotypic information to the tailored feedback at month 3 or 6. After 6 months, there were small but significant improvements in the objectively measured physical activity level (P<.05), moderate PA (P<.01), and sedentary time (P<.001) for individuals advised to increase PA, but these changes were similar across all groups.ConclusionsDifferent levels of personalization produced similar small changes in objective PA. We found no evidence that personalized advice is more effective than conventional “one size fits all” guidelines to promote changes in PA in our Web-based intervention when PA was measured objectively. Based on self-reports, PA increased to a greater extent with more personalized advice. Thus, it is crucial to measure PA objectively in any PA intervention study.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01530139","term_id":"NCT01530139"}}NCT01530139; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01530139","term_id":"NCT01530139"}}NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz)     

Effects of a Web-Based Intervention on Physical Activity and Metabolism in Older Adults: Randomized Controlled Trial

Background

Lack of physical activity leads to detrimental changes in body composition and metabolism, functional decline, and increased risk of disease in old age. The potential of Web-assisted interventions for increasing physical activity and improving metabolism in older individuals holds great promise but to our knowledge it has not been studied.

Objective

The goal of our study was to assess whether a Web-based intervention increases physical activity and improves metabolic health in inactive older adults.

Methods

We conducted a 3-month randomized, waitlist-controlled trial in a volunteer sample of 235 inactive adults aged 60-70 years without diabetes. The intervention group received the Internet program Philips DirectLife, which was directed at increasing physical activity using monitoring and feedback by accelerometer and digital coaching. The primary outcome was relative increase in physical activity measured objectively using ankle- and wrist-worn accelerometers. Secondary outcomes of metabolic health included anthropometric measures and parameters of glucose metabolism.

Results

In total, 226 participants (97%) completed the study. At the ankle, activity counts increased by 46% (standard error [SE] 7%) in the intervention group, compared to 12% (SE 3%) in the control group (P _difference<.001). Measured at the wrist, activity counts increased by 11% (SE 3%) in the intervention group and 5% (SE 2%) in the control group (P _difference=.11). After processing of the data, this corresponded to a daily increase of 11 minutes in moderate-to-vigorous activity in the intervention group versus 0 minutes in the control group (P _difference=.001). Weight decreased significantly more in the intervention group compared to controls (−1.5 kg vs −0.8 kg respectively, P=.046), as did waist circumference (−2.3 cm vs −1.3 cm respectively, P=.036) and fat mass (−0.6% vs 0.07% respectively, P=.025). Furthermore, insulin and HbA1c levels were significantly more reduced in the intervention group compared to controls (both P<.05).

Conclusions

This was the first study to show that in inactive older adults, a 3-month Web-based physical activity intervention was effective in increasing objectively measured daily physical activity and improving metabolic health. Such Web-based interventions provide novel opportunities for large scale prevention of metabolic deregulation in our rapidly aging population.

Trial Registration

Dutch Trial Registry: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6KPw52dCc).     

A Web-Based,Computer-Tailored Smoking Prevention Program to Prevent Children From Starting to Smoke After Transferring to Secondary School: Randomized Controlled Trial

BackgroundSmoking prevalence rates among Dutch children increase rapidly after they transit to secondary school, in particular among children with a low socioeconomic status (SES). Web-based, computer-tailored programs supplemented with prompt messages may be able to empower children to prevent them from starting to smoke when they transit to secondary school.ObjectiveThe main aim of this study is to evaluate whether computer-tailored feedback messages, with and without prompt messages, are effective in decreasing children’s smoking intentions and smoking behavior after 12 and 25 months of follow-up.MethodsData were gathered at baseline (T0), and after 12 months (T1) and 25 months (T2) of follow-up of a smoking prevention intervention program called Fun without Smokes. A total of 162 schools were randomly allocated to a no-intervention control group, an intervention prompt group, or an intervention no-prompt group. A total of 3213 children aged 10 to 12 years old participated in the study and completed a Web-based questionnaire assessing their smoking intention, smoking behavior, and sociocognitive factors, such as attitude, social influence, and self-efficacy, related to smoking. After completion, children in the intervention groups received computer-tailored feedback messages in their own email inbox and those messages could be accessed on the intervention website. Children in the prompt group received prompt messages, via email and short message service (SMS) text messaging, to stimulate them to reuse the intervention website with nonsmoking content. Multilevel logistic regression analyses were performed using multiple imputations to assess the program effects on smoking intention and smoking behavior at T1 and T2.ResultsA total of 3213 children participated in the Fun without Smokes study at T0. Between T0 and T1 a total of 1067 children out of the original 3213 (33.21%) dropped out of the study. Between T0 and T2 the number of children that did not participate in the final measurement was 1730 out of the original 3213 (53.84%). No significant program effects were observed for any of the intervention groups compared to the control group at T1 for the intention to engage in smoking—prompt, OR 0.67 (95% CI 0.30-1.50), no-prompt, OR 0.76 (95% CI 0.34-1.67)—or for smoking behavior—prompt, OR 1.13 (95% CI 0.13-9.98), no-prompt, OR 0.50 (95% CI 0.04-5.59). Similar nonsignificant program effects were found at T2 for the intention to start smoking—prompt, OR 0.78 (95% CI 0.26-2.32), no-prompt, OR 1.31 (95% CI 0.45-3.82)—and smoking behavior—prompt, OR 0.53 (95% CI 0.12-2.47), no-prompt, OR 1.01 (95% CI 0.24-4.21).ConclusionsThis study showed that the Web-based, computer-tailored feedback messages with and without prompt messages were not effective in modifying children’s smoking intentions and smoking behavior as compared to no information. Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake. Furthermore, future studies on Web-based, computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages.

Trial Registration

Netherlands Trial Register NTR3116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 (Archived by WebCite at http://www.webcitation.org/6O0wQYuPI).     

Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial

Background

WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence.

Objective

In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE.

Methods

Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group.

Results

The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support.

Conclusions

Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes.

Trial Registration

Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz).     

Dose-Response Effects of a Web-Based Physical Activity Program on Body Composition and Metabolic Health in Inactive Older Adults: Additional Analyses of a Randomized Controlled Trial

BackgroundLow physical activity is a major risk factor for several age-related diseases. Recently, we showed in a randomized controlled trial that a 12-week Web-based intervention (Philips DirectLife) to increase physical activity was effective in increasing physical activity levels and metabolic health in an inactive population aged 60-70 years.ObjectiveThe goal of this paper was to assess how many participants successfully reached the physical activity level as targeted by the intervention and what the effects of the intervention on body composition and metabolic health in these successful individuals were to provide insight in the maximum attainable effect of the intervention.MethodsAmong the 235 participants in a randomized controlled trial of the Actief en Gezond Oud (AGO) study, we assessed the effects of the intervention on metabolic parameters in those who had successfully reached their personalized physical activity target compared with the entire intervention group. Furthermore, we studied the dose-response effect of increase in physical activity on metabolic outcome within the intervention group.ResultsOf the intervention group, 50 of 119 (42.0%) participants successfully reached the physical activity target (corresponding to a 10% increased daily physical activity on average). This group showed markedly higher effects of the intervention compared to the entire intervention group, with greater decreases in body weight (2.74 vs 1.49 kg), waist circumference (3.74 vs 2.33 cm), insulin resistance (HOMA index: 0.23 vs 0.20), and in cholesterol/HDL ratio (0.39 vs 0.20) and Framingham risk score (0.90% vs 0.54%). We found that men compared to women were more likely to be successful. The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous activity and body weight loss, BMI reduction, waist circumference reduction, HDL cholesterol increasing, and cholesterol/HDL ratio lowering.ConclusionsOf the intervention group, 42.0% (50/119) reached their daily physical activity end goal, which was associated with a markedly better effect on body composition and metabolic health compared to the effect in the entire intervention group. In this population, men are more likely to be successful in increasing physical activity. Findings demonstrate that improving the effect of such physical activity interventions requires finding new ways to increase the proportion of the population reaching the targeted goal.

Trial Registration

Dutch Trial Registry: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6KPw52dCc).     

The Clinical Effectiveness of Web-Based Cognitive Behavioral Therapy With Face-to-Face Therapist Support for Depressed Primary Care Patients: Randomized Controlled Trial

Background

Most patients with mild to moderate depression receive treatment in primary care, but despite guideline recommendations, structured psychological interventions are infrequently delivered. Research supports the effectiveness of Internet-based treatment for depression; however, few trials have studied the effect of the MoodGYM program plus therapist support. The use of such interventions could improve the delivery of treatment in primary care.

Objective

To evaluate the effectiveness and acceptability of a guided Web-based intervention for mild to moderate depression, which could be suitable for implementation in general practice.

Methods

Participants (N=106) aged between 18 and 65 years were recruited from primary care and randomly allocated to a treatment condition comprising 6 weeks of therapist-assisted Web-based cognitive behavioral therapy (CBT), or to a 6-week delayed treatment condition. The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder emails. The primary outcome measure, depression symptoms, was measured by the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS), and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D). All outcomes were based on self-report and were assessed at baseline, postintervention, and at 6-month follow-up.

Results

Postintervention measures were completed by 37 (71%) and 47 (87%) of the 52 participants in the intervention and 54 participants in the delayed treatment group, respectively. Linear mixed-models analyses revealed a significant difference in time trends between the groups for the BDI-II, (P=.002), for HADS depression and anxiety subscales (P<.001 and P=.001, respectively), and for the SWLS (P<.001). No differential group effects were found for the BAI and the EQ-5D. In comparison to the control group, significantly more participants in the intervention group experienced recovery from depression as measured by the BDI-II. Of the 52 participants in the treatment program, 31 (60%) adhered to the program, and overall treatment satisfaction was high. The reduction of depression and anxiety symptoms was largely maintained at 6-month follow-up, and positive gains in life satisfaction were partly maintained.

Conclusions

The intervention combining MoodGYM and brief therapist support can be an effective treatment of depression in a sample of primary care patients. The intervention alleviates depressive symptoms and has a significant positive effect on anxiety symptoms and satisfaction with life. Moderate rates of nonadherence and predominately positive evaluations of the treatment also indicate the acceptability of the intervention. The intervention could potentially be used in a stepped-care approach, but remains to be tested in regular primary health care.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12610000257066; http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000257066 (Archived by WebCite at http://www.webcitation.org/6Ie3YhIZa).     

A Web-Based Health Promotion Program for Older Workers: Randomized Controlled Trial

BackgroundRecent evidence supports the efficacy of programs that promote improvements in the health practices of workers 50 years and older who are at higher risk for chronic diseases than younger workers are. Internet-based programs that promote healthy practices have also shown promise and, therefore, should be especially appropriate for workers aged 50 years and older.ObjectiveThe purpose of the research was to evaluate the effectiveness of HealthyPast50, a fully automated Web-based health promotion program based on social cognitive theory and aimed specifically at workers 50 years and older.MethodsThe randomized controlled trial was conducted across multiple US offices of a large global information technology company. The sample included 278 employees aged 50 to 68 who were recruited online and randomly assigned to the Web-based HealthyPast50 program or to a wait-list control condition. Self-report measures of diet, physical activity, stress, and tobacco use were collected online before and 3 months after the program group was given access to the program. Use data included number of log-ins and number of pages accessed. The primary analysis was multiple linear regression, following intent-to-treat principles with multiple imputation using the Markov chain Monte Carlo (MCMC) approach for nonmonotone missing data. Potential moderators from demographic characteristics and program dosage effects were assessed using multiple linear regression models. Additional analyses were conducted on complete (nonimputed) cases, excluding program participants who used the program for less than 30 minutes.ResultsRetention rates were good for both groups: 80.4% (111/138) for the program group and 94.3% (132/140) for the control group. Program group participants spent a mean of 102.26 minutes in the program (SD 148.32), logged in a mean of 4.33 times (SD 4.28), and viewed a mean of 11.04 pages (SD 20.08). In the analysis of the imputed dataset, the program group performed significantly better than the control group on diet behavioral change self-efficacy (estimated adjusted difference [Δ]=0.16, P=.048), planning healthy eating (Δ=0.17, P=.03), and mild exercise (Δ=1.03, P=.01). Moderator and dosage analyses of the dataset found no significant program effects. Analyses of the nonimputed dataset comparing program users with controls found additional significant program effects on eating practices (Δ=0.09, P=.03), exercise self-efficacy (Δ=0.12, P=.03), exercise planning (Δ=0.18, P=.03), and aging beliefs (Δ=0.17, P=.01). Moderator analysis of this dataset also found significant moderator effects of gender on multiple measures of exercise.ConclusionsA Web-based health promotion program showed promise for making a significant contribution to the short-term dietary and exercise practices of older working adults. Gender effects suggest that the program effects on exercise are due mainly to improvements among women.     

Effectiveness of a Web- and Mobile Phone-Based Intervention to Promote Physical Activity and Healthy Eating in Middle-Aged Males: Randomized Controlled Trial of the ManUp Study

Background

The high number of adult males engaging in low levels of physical activity and poor dietary practices, and the health risks posed by these behaviors, necessitate broad-reaching intervention strategies. Information technology (IT)-based (Web and mobile phone) interventions can be accessed by large numbers of people, yet there are few reported IT-based interventions targeting males’ physical activity and dietary practices.

Objective

This study examines the effectiveness of a 9-month IT-based intervention (ManUp) to improve the physical activity, dietary behaviors, and health literacy in middle-aged males compared to a print-based intervention.

Methods

Participants, recruited offline (eg, newspaper ads), were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favor of the fully automated IT-based arm. Participants were adult males aged 35-54 years living in 2 regional cities in Queensland, Australia, who could access the Internet, owned a mobile phone, and were able to increase their activity level. The intervention, ManUp, was based on social cognitive and self-regulation theories and specifically designed to target males. Educational materials were provided and self-monitoring of physical activity and nutrition behaviors was promoted. Intervention content was the same in both intervention arms; only the delivery mode differed. Content could be accessed throughout the 9-month study period. Participants’ physical activity, dietary behaviors, and health literacy were measured using online surveys at baseline, 3 months, and 9 months.

Results

A total of 301 participants completed baseline assessments, 205 in the IT-based arm and 96 in the print-based arm. A total of 124 participants completed all 3 assessments. There were no significant between-group differences in physical activity and dietary behaviors (P≥.05). Participants reported an increased number of minutes and sessions of physical activity at 3 months (exp(β)=1.45, 95% CI 1.09-1.95; exp(β)=1.61, 95% CI 1.17-2.22) and 9 months (exp(β)=1.55, 95% CI 1.14-2.10; exp(β)=1.51, 95% CI 1.15-2.00). Overall dietary behaviors improved at 3 months (exp(β)=1.07, 95% CI 1.03-1.11) and 9 months (exp(β)=1.10, 95% CI 1.05-1.13). The proportion of participants in both groups eating higher-fiber bread and low-fat milk increased at 3 months (exp(β)=2.25, 95% CI 1.29-3.92; exp(β)=1.65, 95% CI 1.07-2.55). Participants in the IT-based arm were less likely to report that 30 minutes of physical activity per day improves health (exp(β)=0.48, 95% CI 0.26-0.90) and more likely to report that vigorous intensity physical activity 3 times per week is essential (exp(β)=1.70, 95% CI 1.02-2.82). The average number of log-ins to the IT platform at 3 and 9 months was 6.99 (SE 0.86) and 9.22 (SE 1.47), respectively. The average number of self-monitoring entries at 3 and 9 months was 16.69 (SE 2.38) and 22.51 (SE 3.79), respectively.

Conclusions

The ManUp intervention was effective in improving physical activity and dietary behaviors in middle-aged males with no significant differences between IT- and print-based delivery modes.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12611000081910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000081910 (Archived by WebCite at http://www.webcitation.org/6QHIWad63).     

Efficacy of a Web-Based Computer-Tailored Smoking Prevention Intervention for Dutch Adolescents: Randomized Controlled Trial

Background

Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease. This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents.

Objective

The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial. We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years, as smoking uptake in that period is highest.

Methods

The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants. A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition. Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up. Data on smoking initiation were collected from 897 students from these schools. To identify intervention effects, multilevel logistic regression analyses were conducted using multiple imputation.

Results

Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline (OR 0.25, 95% CI 0.05-1.21, P=.09). Additional analyses of the data for the 14-16 year age group showed a significant effect, with 11.5% (24/209) of the students in the control condition reporting initiation compared to 5.7% (10/176) in the experimental condition (OR 0.22, 95% CI 0.05-1.02, P=.05). No moderation effects were found regarding gender and educational level.

Conclusions

The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months, in particular among the age cohort of 14-16 years. Further research is needed to focus on long-term effects.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 77864351; http://www.controlled-trials.com/ISRCTN77864351 (Archived by WebCite at http://www.webcitation.org/6BSLKSTm5).     

Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial

Background

Given the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app.

Objective

The aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels.

Methods

Apps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps.

Results

A total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was –28.4 seconds shorter (95% CI –66.5 to 9.82, P=.20) for the immersive app group and –24.7 seconds (95% CI –63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes.

Conclusions

Although apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12613001030763; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613001030763 (Archived by WebCite at http://www.webcitation.org/6aasfJVTJ).     

Effects of a Web-Based Tailored Multiple-Lifestyle Intervention for Adults: A Two-Year Randomized Controlled Trial Comparing Sequential and Simultaneous Delivery Modes

Background

Web-based computer-tailored interventions for multiple health behaviors can have a significant public health impact. Yet, few randomized controlled trials have tested this assumption.

Objective

The objective of this paper was to test the effects of a sequential and simultaneous Web-based tailored intervention on multiple lifestyle behaviors.

Methods

A randomized controlled trial was conducted with 3 tailoring conditions (ie, sequential, simultaneous, and control conditions) in the Netherlands in 2009-2012. Follow-up measurements took place after 12 and 24 months. The intervention content was based on the I-Change model. In a health risk appraisal, all respondents (N=5055) received feedback on their lifestyle behaviors that indicated whether they complied with the Dutch guidelines for physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking. Participants in the sequential (n=1736) and simultaneous (n=1638) conditions received tailored motivational feedback to change unhealthy behaviors one at a time (sequential) or all at the same time (simultaneous). Mixed model analyses were performed as primary analyses; regression analyses were done as sensitivity analyses. An overall risk score was used as outcome measure, then effects on the 5 individual lifestyle behaviors were assessed and a process evaluation was performed regarding exposure to and appreciation of the intervention.

Results

Both tailoring strategies were associated with small self-reported behavioral changes. The sequential condition had the most significant effects compared to the control condition after 12 months (T1, effect size=0.28). After 24 months (T2), the simultaneous condition was most effective (effect size=0.18). All 5 individual lifestyle behaviors changed over time, but few effects differed significantly between the conditions. At both follow-ups, the sequential condition had significant changes in smoking abstinence compared to the simultaneous condition (T1 effect size=0.31; T2 effect size=0.41). The sequential condition was more effective in decreasing alcohol consumption than the control condition at 24 months (effect size=0.27). Change was predicted by the amount of exposure to the intervention (total visiting time: beta=–.06; P=.01; total number of visits: beta=–.11; P<.001). Both interventions were appreciated well by respondents without significant differences between conditions.

Conclusions

Although evidence was found for the effectiveness of both programs, no simple conclusive finding could be drawn about which intervention mode was more effective. The best kind of intervention may depend on the behavior that is targeted or on personal preferences and motivation. Further research is needed to identify moderators of intervention effectiveness. The results need to be interpreted in view of the high and selective dropout rates, multiple comparisons, and modest effect sizes. However, a large number of people were reached at low cost and behavioral change was achieved after 2 years.

Trial Registration

Nederlands Trial Register: NTR 2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB).     

A Web-Based Adolescent Positive Psychology Program in Schools: Randomized Controlled Trial

BackgroundAdolescent mental health is characterized by relatively high rates of psychiatric disorders and low levels of help-seeking behaviors. Existing mental health programs aimed at addressing these issues in adolescents have repeated inconsistent results. Such programs have generally been based on techniques derived from cognitive behavioral therapy, which may not be ideally suited to early intervention among adolescent samples. Positive psychology, which seeks to improve well-being rather than alleviate psychological symptoms, offers an alternative approach. A previous community study of adolescents found that informal engagement in an online positive psychology program for up to 6 weeks yielded significant improvements in both well-being and depression symptoms. However, this approach had not been trialed among adolescents in a structured format and within a school setting.ObjectiveThis study examines the feasibility of an online school-based positive psychology program delivered in a structured format over a 6-week period utilizing a workbook to guide students through website content and interactive exercises.MethodsStudents from four high schools were randomly allocated by classroom to either the positive psychology condition, "Bite Back", or the control condition. The Bite Back condition consisted of positive psychology exercises and information, while the control condition used a series of non-psychology entertainment websites. Both interventions were delivered online for 6 hours over a period of 4-6 weeks during class time. Symptom measures and measures of well-being/flourishing and life satisfaction were administered at baseline and post intervention.ResultsData were analyzed using multilevel linear modeling. Both conditions demonstrated reductions in depression, stress, and total symptom scores without any significant differences between the two conditions. Both the Bite Back and control conditions also demonstrated significant improvements in life satisfaction scores post intervention. However, only the control condition demonstrated significant increases in flourishing scores post intervention.ConclusionsResults suggest that a structured online positive psychology program administered within the school curriculum was not effective when compared to the control condition. The limitations of online program delivery in school settings including logistic considerations are also relevant to the contradictory findings of this study.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy).