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A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program.

ABSTRACT: This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes.One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4?kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250-1550?kcal per day) and physical activity (200?min per week).While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3?kg [95% confidence interval (CI): -5.8 to -8.8?kg], compared with 2.2?kg (95% CI: -0.7 to -3.7?kg) in the DSME group (P<0.0001). Significantly more PCD than DSME participants lost ?5% of initial weight (54.0% vs 14.0%, P<0.0001) and ?10% (26.0% vs 6.0%, P<0.0001). HbA1c declined by 0.7% (95% CI: -0.4 to -1.0%) in the PCD group, compared with 0.4% (95% CI: -0.1 to -0.7%) in DSME (P<0.026). Across both groups, larger weight losses were associated with greater reductions in HbA1c (r=0.52, P<0.0001).These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.

SUBMITTER: Foster GD

PROVIDER: S-EPMC3608893 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program.

Foster G D GD Wadden T A TA Lagrotte C A CA Vander Veur S S SS Hesson L A LA Homko C J CJ Maschak-Carey B J BJ Barbor N R NR Bailer B B Diewald L L Komaroff E E Herring S J SJ Vetter M L ML

Nutrition & diabetes 20130318

<h4>Objective</h4>This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes.<h4>Research design and methods</h4>One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DS ...[more]

PMID: 23507967

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Project description:Objective:To examine changes in weight and related outcomes in response to a commercial weight loss program compared to a self-directed diet in adults with overweight or obesity. Design:Participants were randomly assigned [stratified by body mass index (BMI) and age] to a commercial weight loss program (n?=?38) or to a self-directed Dietary Approaches to Stop Hypertension (DASH) diet (n?=?40) for a 16-week period. Daily energy intake goals were 1,500?kcal/d for men and 1,200?kcal/d for women, except for the first week of the commercial program (1,000?kcal/d). This study was registered at http://ClinicalTrials.gov (NCT03017443). Participants:Primarily Caucasian (71%) women (n?=?61) and men (n?=?17) from the greater metropolitan area of the city of Chicago, IL, USA. with a mean baseline BMI of 34.4?kg/m2, body weight of 95.7?kg, and age of 50.4?years. Results:Data?=?mean (95% CI). At week 16, the commercial program group lost significantly more body weight [-5.9 (-7.5, -4.3) kg vs. -1.8 (-2.9, -0.8) kg; or -6.4 vs. -1.8% of initial body weight, respectively], fat mass [-4.4 (-5.7, -3.1) kg vs. -1.2 (-2.1, -0.4) kg] and total body circumference (chest?+?waist?+?hip?+?upper arm?+?thigh) [-16.9 (-21.5, -12.3) cm vs. -5.8 (-9.0, -2.6) cm] (p?<?0.01 for all). Additionally, more participants in the commercial program group lost a clinically meaningful amount of weight, defined as ?5% of initial body weight, at week 16 (58% vs. 13%, p?<?0.001). Conclusion:The commercial program resulted in greater weight loss and improvements in body composition/anthropometric parameters compared to a self-directed DASH diet over a 16-week period. Some important limitations were that no objective measurements of dietary intake or physical activity were collected to potentially ascertain the independent or combined effects of these components on weight loss (or lack thereof). Additionally, future research is warranted in order to understand the effects of this program, and similar programs, on longer term changes in body weight, in particular weight loss maintenance, as weight regain is common following the cessation of a structured weight loss intervention.

Project description:BackgroundThe use of smartphone apps to assist in the self-management of hypertension is becoming increasingly common, but few commercially available apps have the potential to be effective along with adequate security and privacy measures in place. In a previous study, we identified 5 apps that are potentially effective and safe, and based on the preferences of doctors and patients, one (Cora Health) was selected as the most suitable app for use in a Saudi context. However, there is currently no evidence of its usability and acceptance among potential users. Indeed, there has been little research into the usability and acceptance of hypertension apps in general, and less research considers this in the Gulf Region.ObjectiveThis study aims to evaluate the acceptance and usability of the selected app in the Saudi context.MethodsThis study used a mixed methods approach with 2 studies: a usability test involving patients in a controlled setting performing predefined tasks and a real-world usability study where patients used the app for 4 weeks. In the usability test, participants were asked to think aloud while performing the tasks, and an observer recorded the number of tasks they completed. At the end of the real-world pilot study, participants were interviewed, and the mHealth App Usability Questionnaire was completed. Descriptive statistics were used to analyze quantitative data, and thematic analysis was used to analyze qualitative data.ResultsIn total, 10 patients completed study 1. The study found that app usability was moderate and that participants needed some familiarization time before they could use the app proficiently. Some usability issues were revealed, related to app accessibility and navigation, and a few tasks remained uncompleted by most people. A total of 20 patients completed study 2, with a mean age of 51.6 (SD 11.7) years. Study 2 found that the app was generally acceptable and easy to use, with some similar usability issues identified. Participants stressed the importance of practice and training to use it more easily and proficiently. Participants had a good engagement level with 48% retention at the end of study 2, with most participants' engagement being classed as meaningful. The most recorded data were blood pressure, followed by stress and medication, and the most accessed feature was viewing graphs of data trends.ConclusionsThis study shows that a commercially available app can be usable and acceptable in the self-management of hypertension but also found a considerable number of possibilities for improvement, which needs to be considered in future app development. The results show that there is potential for a commercially available app to be used in large-scale studies of hypertension self-management if suggestions for improvements are addressed.

Project description:BackgroundThe Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.MethodsThis feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.ResultsOf 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).ConclusionsThe results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.Trial registrationclinicaltrials.gov , NCT03914781 . Registered 16 April 2019.

Dataset Information

A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program.

Publications

A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program.

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