Impact of Plasma-Lyte pH 7.4 on acid-base status and hemodynamics in a model of controlled hemorrhagic shock

OBJECTIVE:

Intravenous infusion of crystalloid solutions is a cornerstone of the treatment of hemorrhagic shock. However, crystalloid solutions can have variable metabolic acid-base effects, perpetuating or even aggravating shock-induced metabolic acidosis. The aim of this study was to compare, in a controlled volume–driven porcine model of hemorrhagic shock, the effects of three different crystalloid solutions on the hemodynamics and acid-base balance.

METHODS:

Controlled hemorrhagic shock (40% of the total blood volume was removed) was induced in 18 animals, which were then treated with normal saline (0.9% NaCl), Lactated Ringer''s Solution or Plasma-Lyte pH 7.4, in a blinded fashion (n = 6 for each group). Using a predefined protocol, the animals received three times the volume of blood removed.

RESULTS:

The three different crystalloid infusions were equally capable of reversing the hemorrhage-induced low cardiac output and anuria. The Lactated Ringer''s Solution and Plasma-Lyte pH 7.4 infusions resulted in an increased standard base excess and a decreased serum chloride level, whereas treatment with normal saline resulted in a decreased standard base excess and an increased serum chloride level. The Plasma-Lyte pH 7.4 infusions did not change the level of the unmeasured anions.

CONCLUSION:

Although the three tested crystalloid solutions were equally able to attenuate the hemodynamic and tissue perfusion disturbances, only the normal saline induced hyperchloremia and metabolic acidosis.     

Leveraging Text Messaging and Mobile Technology to Support Pediatric Obesity-Related Behavior Change: A Qualitative Study Using Parent Focus Groups and Interviews

Background

Text messaging (short message service, SMS) is a widely accessible and potentially cost-effective medium for encouraging behavior change. Few studies have examined text messaging interventions to influence child health behaviors or explored parental perceptions of mobile technologies to support behavior change among children.

Objective

Our aim was to examine parental acceptability and preferences for text messaging to support pediatric obesity-related behavior change.

Methods

We conducted focus groups and follow-up interviews with parents of overweight and obese children, aged 6-12 years, seen for “well-child” care in eastern Massachusetts. A professional moderator used a semistructured discussion guide and sample text messages to catalyze group discussions. Seven participants then received 3 weeks of text messages before a follow-up one-on-one telephone interview. All focus groups and interviews were recorded and transcribed verbatim. Using a framework analysis approach, we systematically coded and analyzed group and interview data to identify salient and convergent themes.

Results

We reached thematic saturation after five focus groups and seven follow-up interviews with a total of 31 parents of diverse race/ethnicity and education levels. Parents were generally enthusiastic about receiving text messages to support healthy behaviors for their children and preferred them to paper or email communication because they are brief and difficult to ignore. Participants anticipated high responsiveness to messaging endorsed by their child’s doctor and indicated they would appreciate messages 2-3 times/week or more as long as content remains relevant. Suggestions for maintaining message relevance included providing specific strategies for implementation and personalizing information. Most felt the negative features of text messaging (eg, limited message size) could be overcome by providing links within messages to other media including email or websites.

Conclusions

Text messaging is a promising medium for supporting pediatric obesity-related behavior change. Parent perspectives could assist in the design of text-based interventions.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01565161","term_id":"NCT01565161"}}NCT01565161; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01565161","term_id":"NCT01565161"}}NCT01565161 (Archived by WebCite at http://www.webcitation.org/6LSaqFyPP).     

Comparison of Virtual Nutri Plus® and Dietpro 5i® software systems for the assessment of nutrient intake before and after Roux-en-Y gastric bypass

OBJECTIVES:

The assessment of nutritional intake before and after bariatric surgery assists in identifying eating disorders, nutritional deficiencies and weight loss/maintenance. The 7-day record is the gold standard for such an assessment and is interpreted using specialized software. This study sought to compare the Virtual Nutri Plus® and Dietpro 5i® software systems in assessing nutrient intake in obese patients with type 2 diabetes mellitus who underwent a Roux-en-Y gastric bypass.

METHODS:

Nutritional intake was assessed in 10 obese women with type 2 diabetes mellitus before and 3 months after Roux-en-Y gastric bypass. The 7-day record was used to assess food intake and then, the Virtual Nutri Plus® and Dietpro 5i® software systems were used to calculate calorie, macronutrient and micronutrient intake based on validated food chemical composition databases. Clinicaltrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01251016","term_id":"NCT01251016"}}NCT01251016.

RESULTS:

During the preoperative period, deficits in the ingestion of total fiber and 15 out of 22 estimated micronutrients were observed when using the Virtual Nutri Plus®, compared to deficiencies in total fiber and 4 micronutrients when using the Dietpro 5i®. During the postoperative period, both the Virtual Nutri Plus® and Dietpro 5i® systems detected deficits in the ingestion of total fiber, carbohydrates and 19 micronutrients, but only the Virtual Nutri Plus® detected deficits in complex B vitamins (except B12) and minerals.

CONCLUSION:

Virtual Nutri Plus® was more sensitive than Dietpro 5i® for the identification of deficits in nutrient intake in obese, type 2 diabetes mellitus patients undergoing Roux-en-Y gastric bypass.     

Patients’ Reported Reasons for Non-Use of an Internet-Based Patient-Provider Communication Service: Qualitative Interview Study

Background

The adoption of Internet-based patient–provider communication services (IPPC) in health care has been slow. Patients want electronic communication, and the quality of health care can be improved by offering such IPPCs. However, the rate of enrollment in such services remains low, and the reasons for this are unclear. Knowledge about the barriers to use is valuable during implementation of IPPCs in the health care services, and it can help timing, targeting, and tailoring IPPCs to different groups of patients.

Objective

The goal of our study was to investigate patients’ views of an IPPC that they could use from home to pose questions to nurses and physicians at their treatment facility, and their reported reasons for non-use of the service.

Methods

This qualitative study was based on individual interviews with 22 patients who signed up for, but did not use, the IPPC.

Results

Patients appreciated the availability and the possibility of using the IPPC as needed, even if they did not use it. Their reported reasons for not using the IPPC fell into three main categories: (1) they felt that they did not need the IPPC and had sufficient access to information elsewhere, (2) they preferred other types of communication such as telephone or face-to-face contact, or (3) they were hindered by IPPC attributes such as login problems.

Conclusions

Patients were satisfied with having the opportunity to send messages to health care providers through an IPPC, even if they did not use the service. IPPCs should be offered to the patients at an appropriate time in the illness trajectory, both when they need the service and when they are receptive to information about the service. A live demonstration of the IPPC at the point of enrollment might have increased its use.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00971139","term_id":"NCT00971139"}}NCT00971139; http://clinicaltrial.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00971139","term_id":"NCT00971139"}}NCT00971139 (Archived by WebCite at http://www.webcitation.org/6KlOiYJrW).     

Early transconjunctival needling revision with 5-fluorouracil versus medical treatment in encapsulated blebs: a 12-month prospective study

OBJECTIVE:

To compare the efficacy of transconjunctival needling revision with 5-fluorouracil versus medical treatment in glaucomatous eyes with uncontrolled intraocular pressure due to encapsulated bleb after trabeculectomy.

METHODS:

Prospective, randomized, interventional study. A total of 40 eyes in 39 patients with elevated intraocular pressure and encapsulated blebs diagnosed at a maximum five months after primary trabeculectomy with mitomycin C were included. The eyes were randomized to either transconjunctival needling revision with 5- fluorouracil or medical treatment (hypotensive eyedrops). A maximum of two transconjunctival needling revisions per patient was allowed in the needling arm. All patients underwent follow-up for 12 months. Successful treatment was defined as an intraocular pressure ≤ 18 mmHg and a 20% reduction from baseline at the final follow-up. Clinicaltrial.gov: {"type":"clinical-trial","attrs":{"text":"NCT01887223","term_id":"NCT01887223"}}NCT01887223.

RESULTS:

Mean intraocular pressure at the final 12-month follow-up was lower in the transconjunctival needling revision group compared to the medical treatment group. Similar numbers of eyes reached the criteria for treatment success in both the transconjunctival needling revision group and the medical treatment group.

CONCLUSIONS:

Despite similar success rates in eyes randomized to transconjunctival needling revision with 5-fluorouracil compared to eyes receiving medical treatment, there was a significantly lower mean intraocular pressure at 12 months after transconjunctival needling revision.     

Surviving and Thriving With Cancer Using a Web-Based Health Behavior Change Intervention: Randomized Controlled Trial

Background

Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors.

Objective

The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors.

Methods

Participants (n=352) were recruited from oncology clinics, a tumor registry, as well as through online mechanisms, such as Facebook and the Association of Cancer Online Resources (ACOR). Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment. Participants were randomly assigned to the Web-based program or a delayed-treatment control condition.

Results

In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls. There were no significant changes in fruit and vegetable consumption or other outcomes.

Conclusions

The Web-based intervention impacted insomnia and exercise; however, a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Thus, the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited. Future work is discussed, with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit, such as in regard to social networking.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00962494","term_id":"NCT00962494"}}NCT00962494; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00962494","term_id":"NCT00962494"}}NCT00962494 (Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q).     

Cognitive Function and Sleep Related Breathing Disorders in a Healthy Elderly Population: the Synapse Study

Study Objectives:

Sleep related breathing disorders (SRBD) are risk factors for cognitive dysfunction in middle-aged subjects, but this association has not been observed in the elderly. We assess the impact of SRBD on cognitive performance in a large cohort of healthy elderly subjects.

Design:

Cross-sectional study examining the association between subjective memory test, neuropsychological battery testing and SRBD in the elderly.

Setting:

Community-based sample in home and research clinical settings.

Participants:

827 subjects, 58.5% women, aged 68 y at study entry, participated in the study. All were free of previously diagnosed SRBD, coronary heart disease, and neurological disorders, including stroke and dementia. Clinical interview, neurological assessment, polygraphy, and extensive cognitive testing were conducted for all participants.

Intervention:

N/A

Measurement and Results:

SRBD (apnea-hypopnea index [AHI] > 15 events/h) was diagnosed in 445 (53%) subjects, 167 (37%) of them with AHI > 30. Minimal daytime sleepiness was found in the group; 9.2% of the population had an Epworth Sleepiness Scale score > 10. No significant association was found between AHI, nocturnal hypoxemia, and cognitive scores. Comparison of mild vs severe cases showed a trend toward lower cognitive scores with AHI > 30, affecting delayed recall and Stroop test.

Conclusions:

The impact of undiagnosed SRBD on cognitive function appeared quite limited in a generally older healthy population, and only slightly affected severe cases. The implication of undiagnosed SRBD on the cognitive impairment in elderly subjects remains hypothetical and needs to be prospectively studied.

Clinical Trial Information:

Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea (SYNAPSE); Registration #{"type":"clinical-trial","attrs":{"text":"NCT 00766584","term_id":"NCT00766584"}}NCT 00766584 (This study is ongoing, but not recruiting participants.); URL - http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00766584","term_id":"NCT00766584"}}NCT00766584?term=NCT+00766584&rank=1

Citation:

Sforza E; Roche F; Thomas-Anterion C; Kerleroux J; Beauchet O; Celle S; Maudoux D; Pichot V; Laurent B; Barthélémy JC. Cognitive function and sleep related breathing disorders in a healthy elderly population: the synapse study. SLEEP 2010;33(4):515-521     

Collecting Maternal Health Information From HIV-Positive Pregnant Women Using Mobile Phone-Assisted Face-to-Face Interviews in Southern Africa

Background

Most of the world’s women living with human immunodeficiency virus (HIV) reside in sub-Saharan Africa. Although efforts to reduce mother-to-child transmission are underway, obtaining complete and accurate data from rural clinical sites to track progress presents a major challenge.

Objective

To describe the acceptability and feasibility of mobile phones as a tool for clinic-based face-to-face data collection with pregnant women living with HIV in South Africa.

Methods

As part of a larger clinic-based trial, 16 interviewers were trained to conduct mobile phone–assisted personal interviews (MPAPI). These interviewers (participant group 1) completed the same short questionnaire based on items from the Technology Acceptance Model at 3 different time points. Questions were asked before training, after training, and 3 months after deployment to clinic facilities. In addition, before the start of the primary intervention trial in which this substudy was undertaken, 12 mothers living with HIV (MLH) took part in a focus group discussion exploring the acceptability of MPAPI (participant group 2). Finally, a sample of MLH (n=512) enrolled in the primary trial were asked to assess their experience of being interviewed by MPAPI (participant group 3).

Results

Acceptability of the method was found to be high among the 16 interviewers in group 1. Perceived usefulness was reported to be slightly higher than perceived ease of use across the 3 time points. After 3 months of field use, interviewer perceptions of both perceived ease of use and perceived usefulness were found to be higher than before training. The feasibility of conducting MPAPI interviews in this setting was found to be high. Network coverage was available in all clinics and hardware, software, cost, and secure transmission to the data center presented no significant challenges over the 21-month period. For the 12 MHL participants in group 2, anxiety about the multimedia capabilities of the phone was evident. Their concern centered on the possibility that their privacy may be invaded by interviewers using the mobile phone camera to photograph them. For participants in group 3, having the interviewer sit beside vs across from the interviewee during the MPAPI interview was received positively by 94.7% of MHL. Privacy (6.3%) and confidentiality (5.3%) concerns were low for group 3 MHL.

Conclusions

Mobile phones were found both to be acceptable and feasible in the collection of maternal and child health data from women living with HIV in South Africa.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00972699","term_id":"NCT00972699"}}NCT00972699; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00972699","term_id":"NCT00972699"}}NCT00972699 (Archived by WebCite at http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00972699","term_id":"NCT00972699"}}NCT00972699)     

Web-Enhanced Tobacco Tactics With Telephone Support Versus 1-800-QUIT-NOW Telephone Line Intervention for Operating Engineers: Randomized Controlled Trial

Background

Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups.

Objective

The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced “Tobacco Tactics” intervention targeting operating engineers (heavy equipment operators) compared to the “1-800-QUIT-NOW” telephone line.

Methods

Operating engineers (N=145) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy (NRT) or to the 1-800-QUIT-NOW telephone line, which provided an equal number of phone calls and NRT. The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up. The outcomes were compared using chi-square tests, t tests, generalized mixed models, and logistic regression models.

Results

The average age was 42 years and most were male (115/145, 79.3%) and white (125/145, 86.2%). Using an intent-to-treat analysis, the Tobacco Tactics website group showed significantly higher quit rates (18/67, 27%) than the 1-800-QUIT NOW group (6/78, 8%) at 30-day follow-up (P=.003), but this difference was no longer significant at 6-month follow-up. There were significantly more positive changes in harm reduction measures (quit attempts, number of cigarettes smoked per day, and nicotine dependence) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group. Compared to participants in the 1-800-QUIT NOW group, significantly more of those in the Tobacco Tactics website group participated in the interventions, received phone calls and NRT, and found the intervention helpful.

Conclusions

The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention. Longer counseling sessions may be needed to improve 6-month cessation rates.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01124110","term_id":"NCT01124110"}}NCT01124110; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01124110","term_id":"NCT01124110"}}NCT01124110 (Archived by WebCite at http://www.webcitation.org/6TfKN5iNL).     

Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial

Background

The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale.

Objective

Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant.

Methods

A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test.

Results

Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike.

Conclusions

The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02229409","term_id":"NCT02229409"}}NCT02229409, https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02229409","term_id":"NCT02229409"}}NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe)     

A Text Message–Based Intervention for Weight Loss: Randomized Controlled Trial

Background

To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.

Objective

This paper describes the development and evaluation of a text message–based intervention designed to help individuals lose or maintain weight over 4 months.

Methods

The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.

Results

A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (−1.97 kg difference, 95% CI −0.34 to −3.60 kg, P = .02) after adjusting for sex and age. Intervention participants’ adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.

Conclusions

Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00415870","term_id":"NCT00415870"}}NCT00415870; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00415870","term_id":"NCT00415870"}}NCT00415870 (Archived by WebCite at http://www.webcitation.org/5dnolbkFt)     

Daily Text Messaging for Weight Control Among Racial and Ethnic Minority Women: Randomized Controlled Pilot Study

Background

Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations.

Objective

This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women.

Methods

Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts.

Results

The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference –2.41 kg, 95% CI –5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=–.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence.

Conclusions

Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention.

Trial Registration

Clinicaltrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT00939081","term_id":"NCT00939081"}}NCT00939081; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT00939081","term_id":"NCT00939081"}}NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).     

MomMoodBooster Web-Based Intervention for Postpartum Depression: Feasibility Trial Results

Background

Postpartum depression (PPD)—the most common complication of childbirth—is a significant and prevalent public health problem that severely disrupts family interactions and can result in serious lasting consequences to the health of women and the healthy development of infants. These consequences increase in severity when left untreated; most women with PPD do not obtain help due to a range of logistical and attitudinal barriers.

Objective

This pilot study was designed to test the feasibility, acceptability, and potential efficacy of an innovative and interactive guided Web-based intervention for postpartum depression, MomMoodBooster (MMB).

Methods

A sample of 53 women who satisfied eligibility criteria (<9 months postpartum, ≥18 years of age, home Internet access and use of personal email, Edinburgh Postnatal Depression Survey score of 12-20 or Patient Health Questionnaire score from 10-19) were invited to use the MMB program. Assessments occurred at screening/pretest, posttest (3 months following enrollment), and at 6 months follow-up.

Results

All six sessions of the program were completed by 87% (46/53) of participants. Participants were engaged with the program: visit days (mean 15.2, SD 8.7), number of visits (mean 20.1, SD 12.2), total duration of visits in hours (mean 5.1, SD 1.3), and number of sessions viewed out of six (mean 5.6, SD 1.3) all support high usage. Posttest data were collected from 89% of participants (47/53) and 6-month follow-up data were collected from 87% of participants (46/53). At pretest, 55% (29/53) of participants met PHQ-9 criteria for minor or major depression. At posttest, 90% (26/29) no longer met criteria.

Conclusions

These findings support the expanded use and additional testing of the MMB program, including its implementation in a range of clinical and public health settings.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00942721","term_id":"NCT00942721"}}NCT00942721; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00942721","term_id":"NCT00942721"}}NCT00942721 (Archived by WebCite at http://www.webcitation.org/6KjYDvYkQ).     

Partnership for Health-2, A Web-Based Versus Print Smoking Cessation Intervention for Childhood and Young Adult Cancer Survivors: Randomized Comparative Effectiveness Study

Background

Smoking among cancer survivors increases the risk of late effects and second cancers. This article reports on Partnership for Health-2 (PFH-2)—an effort to develop an effective and scalable version of Partnership for Health (PFH), which was a previously tested peer-delivered telephone counseling program that doubled smoking cessation rates among childhood cancer survivors who smoke.

Objective

This paper presents results from a randomized controlled trial evaluating the effectiveness of PFH-2 in targeted and tailored Web-based versus print formats. The overall goal was to determine whether the intervention outcomes in these self-guided scalable formats approximate what was found in a more intensive telephone counseling program.

Methods

This study was a randomized controlled trial with a 15-month follow-up that included 374 smokers who were survivors of childhood or young adult cancers, recruited from five survivorship clinics. Participants were randomly assigned to a Web-based or print format of the PFH intervention; all had access to free pharmacotherapy. The website was designed to provide new content at each log-on, and a peer counselor moderated a forum/chat feature. The primary outcome was smoking status at 15 months post randomization.

Results

In total, 58.3% (77/132) of Web participants logged on at least once (mean visits 3.25). Using multiple imputation methods for missing data, there were similar rates of cessation in the two arms (print: 20/128, 15.6%; Web: 33/201, 6.4%), and no differences in quit attempts or readiness to quit. The quit rates were equivalent to those found in our previous telephone counseling intervention. There were high rates of satisfaction with both of the PFH-2 interventions.

Conclusions

The print and Web formats yielded equivalent levels of success to those found with our telephone-delivered intervention and are comparable to other Internet treatment studies. This study provides important options for survivorship programs that may not have resources for interpersonal forms of cessation counseling. Efforts to increase patient use of the interventions may result in higher cessation rates.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00588107","term_id":"NCT00588107"}}NCT00588107; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00588107","term_id":"NCT00588107"}}NCT00588107 (Archived by WebCite at http://www.webcitation.org/6K1gJtFEC).     

Exposure to a Patient-Centered,Web-Based Intervention for Managing Cancer Symptom and Quality of Life Issues: Impact on Symptom Distress

Background

Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness.

Objective

The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report Assessment-Cancer (ESRA-C), and how delivery and total use of the intervention may have affected cancer symptom distress.

Methods

Patients at two cancer centers used ESRA-C to self-report symptom and quality of life (SxQOL) issues during therapy. Participants were randomized to ESRA-C assessment only (control) or the ESRA-C intervention delivered via the Internet to patients’ homes or to a tablet at the clinic. The intervention enabled participants to self-monitor SxQOL and receive self-care education and customized coaching on how to report concerns to clinicians. Overall and voluntary intervention use were defined as having ≥2 exposures, and one non-prompted exposure to the intervention, respectively. Factors associated with intervention use were explored with Fisher’s exact test. Propensity score matching was used to select a sample of control participants similar to intervention participants who used the intervention. Analysis of covariance (ANCOVA) was used to compare change in Symptom Distress Scale (SDS-15) scores from pre-treatment to end-of-study by groups in the matched sample.

Results

Radiation oncology participants used the intervention, overall and voluntarily, more than medical oncology and transplant participants. Participants who were working and had more than a high school education voluntarily used the intervention more. The SDS-15 score was reduced by an estimated 1.53 points (P=.01) in the intervention group users compared to the matched control group.

Conclusions

The intended effects of a Web-based, patient-centered intervention on cancer symptom distress were modified by intervention use frequency. Clinical and personal demographics influenced voluntary use.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00852852","term_id":"NCT00852852"}}NCT00852852; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00852852","term_id":"NCT00852852"}}NCT00852852 (Archived by WebCite at http://www.webcitation.org/6YwAfwWl7).     

Changes in body weight,C-reactive protein,and total adiponectin in non-obese women after 12 months of a small-volume,home-based exercise program

OBJECTIVE:

Our objective was to evaluate the effects of small-volume, home-based exercise combined with slight caloric restriction on the inflammatory markers C-reactive protein and adiponectin.

METHODS:

In total, 54 women were randomly assigned to one of two groups for exercise intervention: the control or home-based exercise groups. Weight, waist and hip circumferences, and inflammatory markers were measured at baseline and after 6 and 12 months. Women allocated to the home-based exercise group received a booklet explaining the physical exercises to be practiced at home at least 3 times per week, 40 minutes per session, at low-to-moderate intensity. All participants received dietary counseling aimed at reducing caloric intake by 100-300 calories per day, with a normal distribution of macro-nutrients (26-28% of energy as fat). Clinicaltrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01206413","term_id":"NCT01206413"}}NCT01206413

RESULTS:

The home-based exercise group showed a significantly greater reduction in weight and body mass index at six months, but no difference between groups was observed thereafter. With regard to the inflammatory markers, a greater but non-statistically significant reduction was found for C-reactive protein in the home-based exercise group at six months; however, this difference disappeared after adjusting for weight change. No differences in adiponectin were found at the 6- or 12-month follow-up.

CONCLUSION:

Small-volume, home-based exercise did not promote changes in inflammatory markers independent of weight change.     

Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

Background

There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown.

Objective

The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention.

Methods

The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no).

Results

At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts.

Conclusions

No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change.

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)     

Cardiovascular Health Effects of Internet-Based Encouragements to Do Daily Workplace Stair-Walks: Randomized Controlled Trial

Background

Although the hazardous health effects of a sedentary lifestyle are well known, many adults struggle with regular physical activity. Simple and efficient encouragements for increased physical activity are needed.

Objective

To determine the effect on cardiovascular health of email-based encouragements to do daily stair-walks at work together with colleagues among adults in sedentary occupations.

Methods

A single-blind randomized controlled trial was performed at a large administrative company in Copenhagen, Denmark. Participants were 160 office workers (125 women, 35 men; mean age 42 years, SD 10; sitting 89.5% of work time). At baseline, aerobic fitness was 37 mL/min/kg (SD 9), mean blood pressure was 118/79 mmHg (SD 14/9), and mean body mass index (BMI) was 23 kg/m² (SD 4). Participants were randomly assigned (2:1 ratio) to an email group receiving weekly email-based encouragements to walk the stairs for 10 minutes a day or to a control group receiving weekly reminders to continue their usual physical activities. The primary outcome was the change from baseline to 10-week follow-up in aerobic fitness determined from a maximal cycle test. The examiner was blinded to group allocation.

Results

Adherence to the email encouragements was fairly high with 82.7% of the participants performing at least 3 sessions of 10-minute stair-walks per week (mean 3.3, SD 1.3). Mean heart rate reached 167 beats/min (SD 10) during stair-walks. In the intention-to-treat analysis, aerobic fitness increased 1.45 mL/min/kg (95% CI 0.64-2.27) at 10-week follow-up in the email group compared with the control group. In participants with low aerobic fitness at baseline (n=56), aerobic fitness increased 1.89 mL/min/kg (95% CI 0.53-3.24), and systolic and diastolic blood pressure decreased 4.81 mmHg (95% CI 0.47-9.16) and 2.67 mmHg (95% CI 0.01-5.32), respectively, in the email group compared with the control group. Body weight decreased in the email group of those with low aerobic fitness compared with the control group, but this was not statistically significant.

Conclusions

Simple and inexpensive email-based encouragements to do daily stair-walks together with colleagues at work improves cardiovascular health among adults in sedentary occupations. There exists an enormous potential to prevent the hazardous health effects of a sedentary lifestyle through the use of email-based encouragements to do short bouts of physical activity at the workplace.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01293253","term_id":"NCT01293253"}}NCT01293253; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01293253","term_id":"NCT01293253"}}NCT01293253 (Archived by WebCite at http://www.webcitation.org/6HWG2jw68).     

Adherence to Self-Monitoring via Interactive Voice Response Technology in an eHealth Intervention Targeting Weight Gain Prevention Among Black Women: Randomized Controlled Trial

Background

eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity.

Objective

This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention.

Methods

The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call.

Results

Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =−.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (−1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference −0.94 kg, 95% CI −1.64 to −0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring.

Conclusions

Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00938535","term_id":"NCT00938535"}}NCT00938535; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00938535","term_id":"NCT00938535"}}NCT00938535 (Archived by WebCite at http://www.webcitation.org/6P1FFNJRs).