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Telecoaching plus a portion control plate for weight care management: a randomized trial.

ABSTRACT: Obesity is a leading preventable cause of death and disability and is associated with a lower health-related quality of life. We evaluated the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control plate for obese patients in a primary care setting.We conducted a randomized, clinical trial among patients in a primary care practice in the midwestern United States. Patients were randomized to either usual care or an intervention including telecoaching with a portion control plate. The intervention was provided during a 3-month period with follow-up of all patients through 6 months after randomization. The primary outcomes were weight, body mass index (BMI),waist circumference, and waist to hip ratio measured at baseline, 6, 12, 18, and 24 weeks. Secondary outcomes included measures assessing eating behaviors, self-efficacy, and physical activity at baseline and at 12 and 24 weeks.A total of 1,101 subjects were pre-screened, and 90 were randomly assigned to telecoaching plus portion control plate (n = 45) or usual care (n = 45). Using last-value carried forward without adjustment for baseline demographics, significant reductions in BMI (estimated treatment effect -0.4 kg/m(2), P =?.038) and waist to hip ratio (estimated treatment effect -.02, P =?.037) at 3 months were observed in the telecoaching plus portion control plate group compared to usual care. These differences were not statistically significant at 6 months. In females, the telecoaching plus portion control plate intervention was associated with significant reductions in weight and BMI at both 3 months (estimated treatment effect -1.6 kg, P =?.016 and -0.6 kg/m(2), P =?.020) and 6 months (estimated treatment effect -2.3 kg, P =?.013 and -0.8 kg/m(2), P =?.025). In males, the telecoaching plus portion control intervention was associated with a significant reduction in waist to hip ratio at 3 months (estimated treatment effect -0.04, P =?.017), but failed to show a significant difference in weight and BMI.Telecoaching with a portion control plate can produce positive change in body habitus among obese primary care patients; however, changes depend upon sex.ClinicalTrials.gov NCT02373878, 13 February 2015. https://clinicaltrials.gov/ct2/show/NCT02373878.

SUBMITTER: Huber JM

PROVIDER: S-EPMC4518583 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Telecoaching plus a portion control plate for weight care management: a randomized trial.

Huber Jill M JM Shapiro Joshua S JS Wieland Mark L ML Croghan Ivana T IT Vickers Douglas Kristen S KS Schroeder Darrell R DR Hathaway Julie C JC Ebbert Jon O JO

Trials 20150730

<h4>Background</h4>Obesity is a leading preventable cause of death and disability and is associated with a lower health-related quality of life. We evaluated the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control plate for obese patients in a primary care setting.<h4>Methods</h4>We conducted a randomized, clinical trial among patients in a primary care practice in the midwestern United States. Patients were randomized to either usua ...[more]

PMID: 26223309

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Project description:BackgroundMobile health (mHealth) may improve pediatric weight management capacity and the geographical reach of services, and overcome barriers to attending physical appointments using ubiquitous devices such as smartphones and tablets. This field remains an emerging research area with some evidence of its effectiveness; however, there is a scarcity of literature describing economic evaluations of mHealth interventions.ObjectiveWe aimed to assess the economic viability of using an mHealth approach as an alternative to standard multidisciplinary care by evaluating the direct costs incurred within treatment arms during a noninferiority randomized controlled trial (RCT).MethodsA digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program was developed iteratively with patients and families using evidence-based approaches. We undertook a microcosting exercise and budget impact analysis to assess the costs of delivery from the perspective of the publicly funded health care system. Resource use was analyzed alongside the RCT, and we estimated the costs associated with the staff time and resources for service delivery per participant.ResultsIn total, 109 adolescents participated in the trial, and 84 participants completed the trial (25 withdrew from the trial). We estimated the mean direct cost per adolescent attending usual care at €142 (SD 23.7), whereas the cost per adolescent in the mHealth group was €722 (SD 221.1), with variations depending on the number of weeks of treatment completion. The conversion rate for the reference year 2013 was $1=€0.7525. The costs incurred for those who withdrew from the study ranged from €35 to €681, depending on the point of dropout and study arm. The main driver of the costs in the mHealth arm was the need for health professional monitoring and support for patients on a weekly basis. The budget impact for offering the mHealth intervention to all newly referred patients in a 1-year period was estimated at €59,046 using the assessed approach.ConclusionsThis mHealth approach was substantially more expensive than usual care, although modifications to the intervention may offer opportunities to reduce the mHealth costs. The need for monitoring and support from health care professionals (HCPs) was not eliminated using this delivery model. Further research is needed to explore the cost-effectiveness and economic impact on families and from a wider societal perspective.Trial registrationClinicalTrials.gov NCT01804855; https://clinicaltrials.gov/ct2/show/NCT01804855.

Project description:BackgroundImplementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).MethodsIn a 12-month trial, families of children (age 7-12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions.ResultsThe mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations.ConclusionsSafety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters.Trial registrationClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.

Project description:Controlling food portion sizes can help reduce energy intake, but the effect of different portion-control methods on weight management is not known. In a 1-year randomized trial, we tested whether the efficacy of a behavioral weight-loss program was improved by incorporating either of the two portion-control strategies instead of standard advice about eating less.The Portion-Control Strategies Trial included 186 women with obesity (81%) or overweight (19%). Participants were randomly assigned to one of three equally intensive behavioral programs, consisting of 19 individual sessions over 12 months. The Standard Advice Group was instructed to eat less food while making healthy choices, the Portion Selection Group was instructed to choose portions based on the energy density using tools such as food scales and the Pre-portioned Foods Group was instructed to structure meals around pre-portioned foods such as single-serving main dishes, for which some vouchers were provided. In an intention-to-treat analysis, a mixed-effects model compared weight loss trajectories across 23 measurements; at month 12, weight was measured for 151 participants (81%).The trajectories showed that the Pre-portioned Foods Group initially lost weight at a greater rate than the other two groups (P=0.021), but subsequently regained weight at a greater rate (P=0.0005). As a result, weight loss did not differ significantly across groups at month 6 (mean±s.e. 5.2±0.4?kg) or month 12 (4.5±0.5?kg). After 1 year, measured weight loss averaged 6% of baseline weight. The frequency of using portion-control strategies initially differed across groups, then declined over time and converged at months 6 and 12.Incorporating instruction on portion-control strategies within a 1-year behavioral program did not lead to a greater weight loss than standard advice. Using pre-portioned foods enhanced early weight loss, but this was not sustained over time. Long-term maintenance of behavioral strategies to manage portions remains a challenge.

Project description:BACKGROUND:Resource barriers complicate diabetes care management. Support from peers may help patients manage their diabetes. OBJECTIVE:To compare a reciprocal peer-support (RPS) program with nurse care management (NCM). DESIGN:Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00320112) SETTING:2 U.S. Department of Veterans Affairs health care facilities. PATIENTS:244 men with hemoglobin A(1c) (HbA(1c)) levels greater than 7.5% during the previous 6 months. MEASUREMENTS:The primary outcome was 6-month change in HbA(1c) level. Secondary outcomes were changes in insulin therapy; blood pressure; and patient reports of medication adherence, diabetes-related support, and emotional distress. INTERVENTION:Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals, receive peer communication skills training, and be paired with another age-matched peer patient. Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact. These patients could also participate in optional group sessions at 1, 3, and 6 months. Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager. RESULTS:Of the 244 patients enrolled, 216 (89%) completed the HbA(1c) assessments and 231 (95%) completed the survey assessments at 6 months. Mean HbA(1c) level decreased from 8.02% to 7.73% (change, -0.29%) in the RPS group and increased from 7.93% to 8.22% (change, 0.29%) in the NCM group. The difference in HbA(1c) change between groups was 0.58% (P = 0.004). Among patients with a baseline HbA(1c) level greater than 8.0%, those in the RPS group had a mean decrease of 0.88%, compared with a 0.07% decrease among those in the NCM group (between-group difference, 0.81%; P < 0.001). Eight patients in the RPS group started insulin therapy, compared with 1 patient in the NCM group (P = 0.020). Groups did not differ in blood pressure, self-reported medication adherence, or diabetes-specific distress, but the RPS group reported improvement in diabetes social support. LIMITATION:The study included only male veterans and lasted only 6 months. CONCLUSION:Reciprocal peer support holds promise as a method for diabetes care management.

Project description:BackgroundObesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.Methods/designWe propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n?=?60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n?=?1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.DiscussionTrial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.Trial registrationCurrent Controlled Trials ISRCTN26563137.

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Telecoaching plus a portion control plate for weight care management: a randomized trial.

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Telecoaching plus a portion control plate for weight care management: a randomized trial.

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