The Mobile Lifestyle Intervention for Food and Exercise Study

Study Overview
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Brief Summary
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The goal of the study is to examine long term sustained weight loss digital intervention in a diverse cohort of adults with overweight/obesity. The intervention includes social gaming (using game-like elements in nongame contexts to promote supportive social interactions and openness to positive behavioral influences) to reward behaviors, such as self-monitoring and social support. Investigators will accomplish objectives and test hypotheses by following two specific primary aims: Determine if the intervention plus gaming produces significantly more weight loss at 12 months than the same intervention without gaming among 240 adults with overweight or obesity and ≥3 T2DM risk factors. Examine the differences in social support provision and receipt between groups at 12 months.

Detailed Description
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This is a 1-year behavioral intervention with standardized behavioral content that reinforces self-monitoring behavior delivered via twice-weekly podcasts, tips of the day, weight, physical activity and diet daily tracking. The mLife App will also encourage and facilitate social support among participants (to both groups). Participants will be randomized to one of two groups: 1) a gamified mLIFE app (n=120) or 2) regular mLIFE app (n=120). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at 6 and 12 months.

Official Title
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Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: The Mobile Intervention for Food and Exercise (mLIFE) Study

Conditions
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Overweight and Obesity, Type2 Diabetes

Intervention / Treatment
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* Behavioral: Podcasts and tips of the day (within app)
* Behavioral: mLIFE app (self-regulation features)
* Behavioral: mLIFE app (social support features)
* Behavioral: standard mLIFE app (social support features)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between 18-65 years old ≥3 T2DM risk factors (as defined by the American Diabetes Association) Own and use a smartphone with a data plan BMI must be between 25-49.9 kg/m2 Must be willing to reduce caloric intake and increase physical activity Not currently participating in a weight loss study in a weight loss program Be free of major health or psychiatric diseases, drug or alcohol dependency. No current use of medications that may impact blood glucose Exclusion Criteria: Over the age of 65 years old Currently participating in a weight loss program Has lost more than 10 pounds in the past 6 months Diagnosed with type 2 diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gamified mLIFE app group<br>Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app. | Behavioral: Podcasts and tips of the day (within app)<br>* Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.<br>Behavioral: mLIFE app (self-regulation features)<br>* Diet (track by in app database), physical activity (tracked with FitBit and synced with mLIFE app), and weight (tracked with FitBit scale and synced with mL app) tracking app components. App notifications and reminders and newsfeeds.<br>Behavioral: mLIFE app (social support features)<br>* The gamified mLIFE app contains several components to help facilitate social gaming and support. This includes a newsfeed, to view the progress of other users, the ability to send others encouragement (likes/thumbs-up) for achieving goals, user-to-user messaging system so active users of the app will be prompted to select send encouraging messages to other group members. For the experimental group, the app also includes features that facilitate healthy competition among participants through receipt of points for provision of social support and tracking health behaviors.<br>|
| Active Comparator: standard mLIFE app<br>Participants in this group will receive the same intervention as the experimental group, but some features of the App will not facilitate gaming or competition. | Behavioral: Podcasts and tips of the day (within app)<br>* Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.<br>Behavioral: mLIFE app (self-regulation features)<br>* Diet (track by in app database), physical activity (tracked with FitBit and synced with mLIFE app), and weight (tracked with FitBit scale and synced with mL app) tracking app components. App notifications and reminders and newsfeeds.<br>Behavioral: standard mLIFE app (social support features)<br>* The standard mLIFE app has the ability to send others encouragement (likes/thumbs-up) for achieving goals and a user-to-user messaging system so active users of the app will be prompted to select send encouraging messages to other group members.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Change in body weight from baseline to 12 months as assessed digitally | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Kcals consumed a day | Change in Kcal from baseline to 12 months as assessed via dietary recalls | 12 months | 
| Change in minutes a week of moderate to vigorous physical activity (MVPA) | Change in minutes a week of MVPA from baseline to 12 months as assessed via accelerometer | 12 months |