Weight Loss
Conditions
Keywords
Obesity, Weight Loss, Diet, Physical Activity, Mobile Health
Brief 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.
Interventions
BEHAVIORALStep 1 Treatment: APP
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.
BEHAVIORALStep 1 Treatment: APP + Coaching
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.
BEHAVIORALStep 2 Treatment Strategy: Modest Step-up
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.
BEHAVIORALStep 2 Treatment Strategy: Vigorous Step-up
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).
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 through 60 years old * BMI between 27 - 45 kg/m2 * \< 350 lbs * Weight stable (no loss or gain \>25 lbs. for the past 6 months) * Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change * Own a Smartphone and be willing to install the SMART App * Reside in the Chicago area for the duration of their participation (12 months)
Exclusion criteria
* Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient ischemic attack, cancer undergoing active treatment, cerebrovascular accident or myocardial infarction within the past six months, or Crohn's disease) * Pregnancy, lactation, or intended pregnancy * Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) * Require assistive device for mobility or current condition that may limit or prevent participation in moderate activity * Use of pacemaker or other electrical implanted device * History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery * May not live with a current or past SMART study participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight at 6 months | baseline, 6 months | Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in weight at 12 months | baseline, 12 months | Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale |
| Cost effectiveness | 12 months | Cost/pound lost of each study sequence embedded within the SMART design. |
Countries
United States
Outcome results
None listed