Obesity is a major public health concern given its high prevalence and associated costs. Most effective weight loss treatments include in-person sessions. mHealth tools (e.g., smartphone app, text messaging) are inexpensive and have the potential to help people achieve and maintain weight loss. In addition, they may be particularly useful as part of a stepped-care sequence of obesity treatments; however, there is considerable heterogeneity in response to mHealth treatments. Although many individuals can achieve clinically meaningful improvements in response to minimal behavioral treatments, many others seem to need more than technology support. There is insufficient evidence to determine whether the first line of treatment should start with an mHealth component alone or include coaching. Moreover, it is unclear whether the augmentation tactic for treating non-responders to the first line treatment should be to offer another mHealth component (i.e,. text messages), or a more traditional treatment component (i.e., coaching or meal replacement). Thus, we propose to utilize a novel experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial) to determine 1) the optimal first line treatment for an obese population; and 2) whether the optimal response to weight loss treatment failure is to modestly or vigorously augment the first line treatment. A total of 400 obese adults will be randomized to one of two potential first line treatments, either (1) an app alone (APP), or (2) the app plus coaching (APP +C). Those who do not respond to the first line treatment (i.e., evidenced by failure to lose weight) will be re-randomized to one of two subsequent augmentation tactics, either: (1) Modestly Step-Up: add another mHealth component (e.g., text messages), or (2) Vigorously Step-Up: add both a mHealth component (e.g., text messages) and a more traditional component (e.g., coaching, meal replacement). Responders will continue with the same first line treatment for 12 weeks. Assessments will be completed at 3, 6, and 12 months. The proposed project is significant because it aims to develop an effective and scalable obesity treatment that will move from the one-size-fits-all approach to a time-sensitive, dynamic approach for weight management.
|Effective start/end date||3/1/16 → 2/28/22|
- National Institute of Diabetes and Digestive and Kidney Diseases (5R01DK108678-04)