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SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management.

ABSTRACT: BACKGROUND:Stepped care is a rational resource allocation approach to reduce population obesity. Evidence is lacking to guide decisions on use of low cost treatment components such as mobile health (mHealth) tools without compromising weight loss of those needing more expensive traditional treatment components (e.g., coaching, meal replacement). A sequential multiple assignment randomization trial (SMART) will be conducted to inform the development of an empirically based stepped care intervention that incorporates mHealth and traditional treatment components. OBJECTIVE:The primary aim tests the non-inferiority of app alone, compared to app plus coaching, as first line obesity treatment, measured by weight change from baseline to 6?months. Secondary aims are to identify the best tactic to address early treatment non-response and the optimal treatment sequence for resource efficient weight loss. STUDY DESIGN:Four hundred participants, 18-60?years old with Body Mass Index between 27 and 45?kg/m2 will be randomized to receive a weight loss smartphone app (APP) or the app plus weekly coaching (APP + C) for a 12?week period. Those achieving <0.5?lb. weight loss on average per week, assessed by wireless scale at 2, 4, and 8?weeks, will be classified as non-responders and re-randomized once to step-up modestly (adding another mHealth component) or vigorously (adding mHealth and traditional treatment components) for the remaining treatment period. Weight will be assessed in person at baseline, 3, 6, and 12?months. SIGNIFICANCE:Results will inform construction of an obesity treatment algorithm that balances weight loss outcomes with resource consumption.

SUBMITTER: Pfammatter AF

PROVIDER: S-EPMC6624080 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management.

Pfammatter Angela Fidler AF Nahum-Shani Inbal I DeZelar Margaret M Scanlan Laura L McFadden H Gene HG Siddique Juned J Hedeker Donald D Spring Bonnie B

Contemporary clinical trials 20190523

<h4>Background</h4>Stepped care is a rational resource allocation approach to reduce population obesity. Evidence is lacking to guide decisions on use of low cost treatment components such as mobile health (mHealth) tools without compromising weight loss of those needing more expensive traditional treatment components (e.g., coaching, meal replacement). A sequential multiple assignment randomization trial (SMART) will be conducted to inform the development of an empirically based stepped care in ...[more]

PMID: 31129369

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Project description:BackgroundMinority adolescents are at highest risk for obesity and extreme obesity; yet, there are few clinical trials targeting African American adolescents with obesity.PurposeThe purpose of the study was to develop an adaptive family-based behavioral obesity treatment for African American adolescents using a sequential multiple assignment randomized trial (SMART) design.MethodsFit Families was a SMART where 181 African American adolescents (67% female) aged 12-17 were first randomized to office-based versus home-based behavioral skills treatment delivered from a Motivational Interviewing foundation. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based behavioral skills treatment or contingency management with voucher-based reinforcement for adolescent weight loss and for caregiver adherence to the program. All interventions were delivered by community health workers. The primary outcome was treatment retention and percent overweight.ResultsAll adolescents reduced percent overweight by -3.20%; there were no significant differences in percent overweight based on treatment sequence. Adolescents receiving home-based delivery in Phase 1 and contingency management in Phase 2 completed significantly more sessions than those receiving office-based treatment and continued skills without CM (M = 8.03, SD = 3.24 and M = 6.62, SD = 2.95, respectively). The effect of contingency management was strongest among older and those with lower baseline confidence. Younger adolescents experienced greater weight reductions when receiving continued skills (-4.90% compared with -.02%).ConclusionsBehavioral skills training can be successfully delivered to African American adolescents with obesity and their caregivers by community health workers when using a home-based service model with incentives. More potent interventions are needed to increase reductions in percent overweight and may need to be developmentally tailored for younger and older adolescents.

Project description:IntroductionOver 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.Methods and analysisThis study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).Ethics and disseminationStudy protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.Trial registration numberclinicaltrials.gov; NCT05666323.

Dataset Information

SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management.

Publications

SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management.

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