At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SMART Weight Loss Management
In Brief
A clinical study evaluating Step 1 Treatment: APP, Step 1 Treatment: APP + Coaching, and 2 other interventions for Weight Loss. Completed, enrolled 400 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive a smartphone app to track weight, dietary intake and physical activity, and a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker. Participants will use their own smartphone to receive the study smartphone application.
Participants will receive a smartphone app to track weight, dietary intake and physical activity; a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker; 12 weekly telephone coaching sessions. Participants will use their own smartphone to receive the study smartphone application.
In addition to first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) for the remaining 12 weeks.
In addition to the first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) plus a traditional weight loss intervention component (coaching, meal replacements).