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Clinical Trial Summary

The overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. The SMART approach is a highly efficient strategy for identifying and constructing efficacious adaptive interventions: it accommodates sequential decision-making based on the participant's response to early weight loss treatment components. The proposed treatment package begins with the least expensive components, and for participants identified as treatment non-responders, provides sequential step-up of additional treatment components. By sequentially delivering treatment components based on participant response, SMART permits achievement of the target outcome, weight loss, with least resource consumption and participant burden.

Clinical Trial Description

The proposed study seeks to develop an effective, resource-sensitive strategy to manage weight loss treatment for obesity. During the 12-week active intervention phase, participants will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the addition of an additional mHealth component plus a traditional weight loss intervention component. Treatment responders will continue with the same first-line treatment. Treatment response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will be re-randomized at that time. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02997943
Study type Interventional
Source Northwestern University
Status Completed
Phase N/A
Start date June 19, 2017
Completion date March 18, 2021

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