An interventional study of Step 1 Treatment: APP and Step 1 Treatment: APP + Coaching in Weight Loss, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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.
1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.
This study's enrollment of 400 is above the median of 73 across 1,540 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
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Exclusion Criteria:
Participants will first be randomized to an optimal first line treatment in order to compare APP vs. APP + coaching. Participants assigned to Step 1 treatment "APP" will receive a study-specific smartphone application. Participants assigned to Step 1 treatment "APP + coaching" will receive a study-specific smartphone application plus 12 weekly telephone coaching sessions.
Behavioral: Step 1 Treatment: APP · Behavioral: Step 1 Treatment: APP + Coaching
Beginning at week 2, participants who are identified as treatment non-responders will be re-randomized in order to compare two strategies to address non-response: a modest step-up or vigorous step-up treatment augmentation tactic. Step 2 treatment strategy: modest step-up will include provision of an additional mHealth intervention component (push notifications). Step 2 treatment strategy vigorous step-up will include provision of an additional mHealth intervention component (push notifications), plus a traditional weight loss intervention component (coaching, meal replacements). Participants will continue to receive their first line treatment.
Behavioral: Step 2 Treatment Strategy: Modest Step-up · Behavioral: Step 2 Treatment Strategy: Vigorous Step-up
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).
Change in weight at 6 months
Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
Time frame: baseline, 6 months
Change in weight at 12 months
Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
Time frame: baseline, 12 months
Cost effectiveness
Cost/pound lost of each study sequence embedded within the SMART design.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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