- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05176847
The Mobile Lifestyle Intervention for Food and Exercise Study (mLIFE)
Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: The Mobile Intervention for Food and Exercise (mLIFE) Study
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gamified mLIFE app group
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
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Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
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.
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. |
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Active Comparator: standard mLIFE app
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.
|
Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: 12 months
|
Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Energy Intake
Time Frame: 12 months
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Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake.
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12 months
|
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Change in Weekly Moderate to Vigorous Physical Activity (MVPA)
Time Frame: 12 months
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Difference in average weekly minutes of moderate-to-vigorous physical activity (MVPA) between follow-up and baseline (follow-up - baseline), derived from Fitbit physical activity data; positive values indicate increased MVPA.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brie Turner-Mcgrievy, University of South Carolina
Publications and helpful links
General Publications
- Turner-McGrievy G, Monroe C, Delgado-Diaz C, Aydin HZ, DuBois K, Kim Y, Valafar H, Wilcox S. Incentivizing social support in the randomized mobile Lifestyle Intervention for Food and Exercise study: the impact of gamification on social support perceptions, provision, and receipt. Transl Behav Med. 2026 Jan 7;16(1):ibaf086. doi: 10.1093/tbm/ibaf086.
- DuBois KE, Delgado-Diaz DC, McGrievy M, Valafar H, Monroe C, Wilcox S, Turner-McGrievy G. The Mobile lifestyle intervention for food and exercise (mLife) study: Protocol of a remote behavioral weight loss randomized clinical trial for type 2 diabetes prevention. Contemp Clin Trials. 2025 Jan;148:107735. doi: 10.1016/j.cct.2024.107735. Epub 2024 Nov 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00109784
- 1R01DK129302 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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