NCT03980743.
Study name | Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA‐SMI (iOTA‐eSMI) |
Methods | Randomised controlled trial |
Participants | Overweight or obese adults with a history of serious mental illness |
Interventions |
Behavioural: iOTA text messaging intervention: Over 6 months, participants in the iOTA arm will have monthly in‐person visits with a health coach who will work with participants to set goals for the upcoming month related to healthy eating and activity. Participants will receive daily text message health tips related to their goals and will be prompted once a week to respond with a text indicating their weight and how they are doing with their goals. Following the 6‐month active treatment phase, participants will receive text messages only for another 3 months Behavioural: health education text messaging intervention: Over 6 months, participants in the Health Ed arm will also have monthly in‐person visits with a health coach who will provide education on energy balance and problem‐solving. Specific goals will not be set, but the health coach will assist participants in problem‐solving any challenges. Participants will receive a weekly automated motivational text message health tip related to what they learned in their health coaching sessions. Following the 6‐month active treatment phase, participants will receive text messages only for another 3 months |
Outcomes | Primary outcome: change in body mass index (time frame: baseline, 4, 8, 12, 16, 20, 24, and 36 weeks) |
Starting date | June 2020 |
Contact information | Principal Investigator: Ginger E Nicol, MD Washington University of Medicine |
Notes |