SMART Weight Loss Management
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Step 1 Treatment: APP; Step 1 Treatment: APP + Coaching; Step 2 Treatment Strategy: Modest Step-up; Step 2 Treatment Strategy: Vigorous Step-up
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss; Diet; Physical Activity; Mobile Health