Physical activity and nutrition programs for couples: a randomized controlled trial

Diet and physical activity habits may deteriorate after cohabitation, leading to weight gain and increased risk of lifestyle diseases. We carried out a 4-month, randomized controlled trial of a diet and physical activity program for couples with a 1-year follow-up, comparing two methods of delivery. The program used six modules, which, after an initial group session, were mailed to the low-level intervention group. In the high-level intervention group, half of the modules were mailed, and the others were delivered at interactive group sessions. A control group received no intervention. Postintervention and at follow-up, physical fitness improved in the high-level group, saturated fat intake decreased in both intervention groups, and low-density lipoprotein cholesterol fell in the high-level group. Fewer participants in the high-level group became overweight or obese. Health promotion for couples can improve health behaviors and potentially lower the risk of lifestyle diseases in participants and their future families.     

Physical activity measurements affected participants' behavior in a randomized controlled trial

Background and ObjectiveAssessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice.MethodsUsing a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity.ResultsFollow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change.ConclusionMeasurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.     

Print versus website physical activity programs: a randomized trial

BACKGROUND: Mediated physical activity interventions can reach large numbers of people at low cost. Programs delivered through the mail that target the stage of motivational readiness have been shown to increase activity. Communication technology (websites and e-mail) might provide a means for delivering similar programs. METHODS: Randomized trial conducted between August and October 2001. Participants included staff at an Australian university (n=655; mean age=43, standard deviation, 10 years). Participants were randomized to either an 8-week, stage-targeted print program (Print) or 8-week, stage-targeted website (Web) program. The main outcome was change in self-reported physical activity. RESULTS: There was no significant increase in total reported physical activity within or between groups when analyzed by intention to treat (F [1,653]=0.41, p=0.52). There was a significant increase in total physical activity reported by the Print participants who were inactive at baseline (t [1,173]=-2.21, p=0.04), and a significant decrease in the average time spent sitting on a weekday in the Web group (t [1,326]=2.2, p=0.03). CONCLUSIONS: There were no differences between the Print and Web program effects on reported physical activity. The Print group demonstrated slightly larger effects and a higher level of recognition of program materials.     

Maintaining physical activity among older adults: six-month outcomes of the Keep Active Minnesota randomized controlled trial

OBJECTIVE: We evaluate the 6-month efficacy of Keep Active Minnesota, a phone- and mail-based physical activity maintenance intervention designed for use with adults age 50 to 70 years who have increased their physical activity within the past year. METHOD: Participants (N=1049) recruited in 2004 and 2005 from one large managed-care organization in Minnesota were randomly assigned to either treatment (N=523) or usual care (N=526) with physical activity assessed using the Community Healthy Activities Model Program for Seniors questionnaire, and expressed as kcal/week expenditures. RESULTS: Total physical activity at baseline was similar for treatment and usual care participants (p<0.44) as was moderate/vigorous physical activity (p<0.21). Maintenance of physical activity was higher among treatment participants whose mean 6-month change in total kcal/week energy expenditure was -91, compared to -683 for usual care participants (p<0.002). Mean 6-month change in kcal/week expenditure in moderate or vigorous activities was -49 for treatment participants, compared to -612 for usual care participants (p<0.001). CONCLUSIONS: This phone- and mail-based physical activity maintenance intervention is efficacious at maintaining physical activity at 6 months.     

Physical activity and nutrition program for seniors (PANS): protocol of a randomized controlled trial

Background  

Along with reduced levels of physical activity, older Australian's mean energy consumption has increased. Now over 60% of older Australians are considered overweight or obese. This study aims to confirm if a low-cost, accessible physical activity and nutrition program can improve levels of physical activity and diet of insufficiently active 60-70 year-olds.     

Impact of integrating a physical activity counsellor into the primary health care team: physical activity and health outcomes of the Physical Activity Counselling randomized controlled trial

The purpose of this paper was to report the physical activity and health outcomes results from the Physical Activity Counselling (PAC) trial. Patients (n = 120, mean age 47.3 ± 11.1 years, 69.2% female) who reported less than 150 min of physical activity per week were recruited from a large community-based Canadian primary care practice. After receiving brief physical activity counselling from their provider, they were randomized to receive 6 additional patient-centered counselling sessions over 3 months from a physical activity counsellor (intensive-counselling group; n = 61), or no further intervention (brief-counselling group; n = 59). Physical activity (self-reported and accelerometer) was measured every 6 weeks up to 25 weeks (12 weeks postintervention). Quality of life was also assessed, and physical and metabolic outcomes were evaluated in a randomly selected subset of patients (33%). In the intent-to-treat analyses of covariance, the intensive-counselling group self-reported significantly higher levels of physical activity at 6 weeks (p = 0.009) and 13 weeks (p = 0.01). There were no differences in self-reported physical activity between the groups after the intervention in the follow-up period, nor was there any increase in accelerometer-measured physical activity. Finally, the intensive-counselling patients showed greater decreases in percent body fat and total fat mass from 13 weeks to 25 weeks. Results for physical activity depended on the method used, with positive short-term results with self-report and no effects with the accelerometers. Between-group differences were found for body composition in that the intensive-counselling patients decreased more. A multisite randomized controlled trial with a longer intensive intervention and follow-up is warranted.     

Statistical analysis of cost outcomes in a randomized controlled clinical trial

This paper suggests an approach to deal with an estimation problem which is often encountered in analyzing the longitudinal cost data gathered in a clinical trial. The source of that estimation problem is twofold: 1) a considerable number of missing data due to treatment-related withdrawal of severely affected patients with high health care costs in only one the treatment groups and 2) a heavily skewed cost distribution due to rare high-cost events. The approach is illustrated using data from a trial comparing 3 different drug regimes. In order to calculate costs per patient-year in case of selectively missing data we extrapolated the costs of patients with incomplete follow-up. Due to the skewness and the associated large variance in costs per patient-year, these costs cannot be analyzed using common parametric statistical methods relying on underlying normal distributions. A logarithmic transformation was performed to approximate a normal distribution, reduce the impact of extreme values and create similar size variances in the treatment groups. An ordinary least squares regression analysis of transformed data then standardized for differences in patient characteristics between the groups. For the retransformation, the so-called smearing estimate was used. This ‘transformation-standardization-retransformation’ approach enabled us to provide more consistent and efficient estimates of cost differences that were shown to be statistically significant and judged to be important.     

Testing a workplace physical activity intervention: a cluster randomized controlled trial

Background  

Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels.     

A randomized controlled trial of home telecare

We have established a randomized controlled trial of home telecare. The intervention aims to address a growing problem in the National Health Service (NHS), that is, high admission rates of patients with exacerbations of chronic obstructive pulmonary disease (COPD). Equipment procurement for the trial has been difficult, as no single supplier was able to meet the project s full requirements. The fact that the service is provided by existing clinical NHS staff has advantages when considering the generalizability of the results within the NHS. However, there are also disadvantages, since existing staff have little research experience. Considerable time has been required to help staff familiarize themselves with the equipment and become comfortable with its use. This has posed a barrier to the implementation of the service.     

Promotion of physical activity among high-school girls: a randomized controlled trial

OBJECTIVES: Many adolescent girls fail to meet national guidelines for physical activity, and the prevalence of obesity is increasing among this group. Our study examined the effects of a comprehensive school-based intervention on physical activity among high-school girls. METHODS: A group-randomized controlled field trial was conducted at 24 high schools. A school-based sample of 2744 girls (48.7% African American, 46.7% White) participated in a measurement protocol when they were in eighth and then ninth grade. A comprehensive physical activity intervention was designed to change the instructional program and the school environment to increase support for physical activity among girls. RESULTS: At follow-up, 45% of girls in the intervention schools and 36% of girls in the control schools reported vigorous physical activity during an average of 1 or more 30-minute time blocks per day over a 3-day period. CONCLUSIONS: A comprehensive school-based intervention can increase regular participation in vigorous physical activity among high-school girls.     

Physical activity to prevent obesity in young children: cluster randomised controlled trial

Physical activity to prevent obesity in young children: cluster randomised controlled trial . Reilly , J. J. , Kelly , L. , Montgomery , C. , Williamson , A. , Fisher , A. , McColl , J. H. , Lo Conte , R. , Paton , J. Y. & Grant , S. ( 2006 ) British Medical Journal , 333 , 1041 DOI: 10.1136/bmj.38979.623773.55.     

Objectively-assessed physical activity and weight change in young adults: a randomized controlled trial

Background

Reductions in physical activity (PA) are common throughout young adulthood and low PA is associated with weight gain. The SNAP Trial previously reported that two self-regulation approaches to weight gain prevention reduced weight gain over a 2-year period in 18–35 year olds. Presented here are secondary analyses examining changes in PA and the relationship between PA and weight change over 2 years.

Methods

599 young adults (age: 27.4?±?4.4 yrs.; BMI: 25.4?±?2.6 kg/m²) were randomly assigned to 1 of 3 treatment arms: Small Changes (reduce calorie intake by 100 kcals/day & add 2000 steps/day), Large Changes (lose 2.3–4.5 kg initially & increase PA to ≥250 min/wk), or Self-guided (control condition). Small and Large Changes received 10, face-to-face group sessions (months 1–4), and two 4-week refresher courses each subsequent year. Body weight and PA were objectively-measured at baseline, 4 months, 1 and 2 years. Daily steps and bout-related moderate-to-vigorous intensity PA (MVPA: ≥3 METs, ≥10-min bouts) was calculated.

Results

Changes in bout-related MVPA and daily steps did not differ among treatment groups over the 2-year period (p’s?>?0.16). Collapsed across groups, participants gaining >1 lb. (n?=?187; 39.6%) had smaller changes in bout-related MVPA at 4 months, 1 and 2 years relative to those maintaining or losing weight (≤1 lb. weight gain; n?=?282, 60.4%, p’s?<?0.05). Averaged across time points, this difference equated to 47.8 min/week. Those gaining and not gaining >1 lb. did not differ on daily steps (p’s?>?0.10). Among participants engaging in ≥250 min/wk. of MVPA at 2 years (n?=?181), 30% gained >1 lb. from baseline to 2 years, which was not different from those engaging in 150–250 min/wk. (n?=?87; 36%; p?=?0.40), but this percentage was significantly lower when compared to those engaging in <150 min/wk. (n?=?176; 49%; p?<?0.001).

Conclusions

On average, PA differences were not observed between young adults assigned to small or large changes self-regulation interventions to prevent weight gain. Regardless of group assignment, higher levels of MVPA were associated with better weight gain prevention over 2 years. Our data suggest that achieving >150 min/week of MVPA is needed for weight gain prevention and that increasing MVPA, rather than steps, should be targeted.

Trial registration

www.clinicaltrials.gov (NCT01183689). Registered Aug 13, 2010.

     

Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa

OBJECTIVE: To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%. METHODS: A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment. FINDINGS: The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation. CONCLUSION: This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required.     

A randomized controlled trial of information-giving to patients referred for coronary angiography: effects on outcomes of care

Objective To assess the impact of providing an educational videotape, ` Treatment Choices for Ischaemic Heart Disease: a Shared Decision-Making Program Videotape ,' to patients referred for coronary angiography compared with standard patient-physician decision making (usual care).
Study design Randomized controlled clinical trial.
Setting University Hospital and Veterans Affairs Hospital.
Patients A consecutive sample of 217 patients referred for coronary angiography were randomized to receive `usual care' or to receive the videotape in addition to standard patient physician decision making (videotape): 109 completed the study (50% completion rate).
Main outcome measures Knowledge of coronary artery disease, satisfaction, self-reported physical and mental health functioning, and the proportion of patients who were referred for coronary revascularization.
Results Compared with patients who received `usual care,' those who received the videotape were more knowledgeable (mean score 83 vs. 58%; P  < 0.0001) but less satisfied with their treatment (79 vs. 88%; P  = 0.038). There were no significant differences between the videotape and `usual care' groups with respect to satisfaction with the decision making process (mean score 73 vs. 77%; P  = 0.37), satisfaction with the decision made (mean score 73 vs. 78%; P  = 0.28), physical functioning (38 vs. 38%; P  = 0.76), mental health functioning (49 vs. 49%; P  = 0.94), or in referral for coronary revascularization (OR 0.60; 95% CI 0.22–1.65; P  = 0.33).
Conclusion Although the educational videotape increased patients' knowledge level, it was associated with a decrease in their level of satisfaction with treatment. Before there is wide-spread dissemination of this technology, advocates should demonstrate its effectiveness in everyday practice.