Mentoring in Mobile Health (mHealth) and Social Networking Interventions for Cardiovascular Disease Risk Reduction: Intervention Phase
Mentoring in Mobile Health (mHealth) and Social Networking Interventions for Cardiovascular Disease Risk Reduction: Intervention Phase
Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle interventions prescribe daily food tracking for the length of the program which can range from 3-24 months. This can be a taxing prescription that is not feasible to do long term for many people. The purpose of this pilot feasibility randomized trial is to test the feasibility of 3 tracking prescriptions during an 8 week digital weight loss intervention: 1) tracking daily, 2) tracking two weeks on and one week off, 3) tracking every other week. Feasibility is defined as tracking prescription compliance, burden, acceptability, and perceived efficacy, and tracking self-efficacy. Diet tracking will be evaluated one month after the intervention ends so that groups can be compared on diet tracking maintenance.
The investigators propose a pilot randomized feasibility trial in which they will randomize 108 people to 3 remotely-delivered weight loss intervention groups that vary based on their diet tracking prescription. The primary outcome will be feasibility, acceptability, and perceived efficacy of the "lighter" tracking prescriptions. Each group will have 36 participants and the intervention will last 8 weeks. They will do assessments at baseline, 8 weeks, and 12 weeks. The 8 week assessment will include weight, diet tracking records, and a survey on acceptability. The 12 week assessment will evaluate weight and diet tracking in the month following the intervention which will allow them to explore diet tracking persistence in that time period. All three intervention groups will receive the same remotely delivered lifestyle intervention, but will vary based on three different tracking prescriptions: 1) Standard Diet Tracking Prescription: This group will be asked to track their diet every day for 8 weeks.
2) 66% Tracking Prescription. This group will be asked to track for 2 weeks, then they will get a 1 week break, track for 2 more weeks and then get a 1 week break, and then track for 2 weeks. 3) 50% Tracking Prescription. This group will be asked to track every other week which would result in 4 weeks of tracking and 4 weeks off of tracking. The primary outcome of this trial is feasibility as defined as: 1) compliance with the tracking prescription (i.e., % of prescribed days with complete tracking, % tracking in week 8) 2) burden of tracking prescription (e.g., time consuming, hard to remember) 3) acceptability of tracking prescription (e.g., ease, plans to continue the prescription) 4) perceived efficacy of tracking prescription (e.g., "tracking this often is enough to help me lose weight"). 5) self-efficacy of diet tracking (e.g., "I feel confident I could continue this tracking prescription for the next 3 months"). 6) number of diet tracking days in the subsequent month. Percent weight loss at 8 and 12 weeks in each group will be exploratory outcomes and presented descriptively as this pilot is not powered to establish efficacy. Feasibility hypotheses and/or benchmarks are as follows:
Findings from this pilot randomized feasibility trial will be used to inform an efficacy trial comparing one or both "light" tracking prescriptions to the standard tracking prescription on weight loss at 3, 6, and 12 months.
Inclusion Criteria:
Exclusion Criteria: