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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK129302 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamified mLIFE app group | Experimental | Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app. |
|
| standard mLIFE app | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Podcasts and tips of the day (within app) | Behavioral | Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Energy Intake | Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake. | 12 months |
| Change in Weekly Moderate to Vigorous Physical Activity (MVPA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brie Turner-Mcgrievy | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41498406 | Derived | 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. | |
| 39522630 | Derived | 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. |
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Eligible and interested participants were offered a choice of orientation session times. During the session, the study coordinator provided a comprehensive overview of the study, addressed participant questions, and obtained informed consent. Participants were guided in establishing Fitbit accounts, synchronizing physical activity and weight trackers, and completing baseline assessments. Those who successfully completed baseline procedures were subsequently randomized.
The mLife study was a 52-week parallel group randomized behavioral intervention conducted with two sequential cohorts. Recruitment was implemented through targeted advertisements on social media platforms (Facebook and Instagram) and ResearchMatch, directing prospective participants to a study website for eligibility screening. Eligible individuals completed a phone screener and attended a virtual orientation to review procedures and provide informed consent. Recruitment occurred Feb 18-May 20,
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| ID | Title | Description |
|---|---|---|
| FG000 | Gamified mLIFE App Group | Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gamified mLIFE App Group | Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app. |
| BG001 | Standard mLIFE App |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant's age at baseline assessment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain. | Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis. | Posted | Least Squares Mean | Standard Error | Kg | 12 months |
|
From enrollment until end of study, up to 52 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gamified mLIFE App Group | Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck injury due to fall | Musculoskeletal and connective tissue disorders | monthly questionnair | Systematic Assessment | Fall with neck injury; serious (disability, surgery 12/21/23); not related to intervention; pre-existing spinal disease; withdrew. |
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The study sample lacked diversity in race/ethnicity and education. Participant attrition was higher than anticipated. Not all potential social support factors were assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brie Turner-McGrievy | University of South Carolina | 8037773932 | brie@sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2023 | Jan 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 18, 2022 | Nov 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| mLIFE app (self-regulation features) | Behavioral | 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. |
|
| mLIFE app (social support features) | Behavioral | 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. |
|
| standard mLIFE app (social support features) | Behavioral | 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. |
|
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.
| 12 months |
| Removed from analysis |
|
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.
| BG002 | Total | Total of all reporting groups |
Age at baseline assessment
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex at baseline assessment | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body weight, | body weight was assessed via the provided Fitbit Aria Air scale (Google) | Mean | Standard Deviation | kg |
|
| Energy intake | kcals consumed in a day - 24h dietary recall | Mean | Standard Deviation | kcal/d |
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| Physical Activity | Estimated min/wk of moderate-to-vigorous physical activity (MVPA). Fitbit Physical Activity data | Mean | Standard Deviation | minutes/wk |
|
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|
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| Secondary | Change in Energy Intake | Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake. | Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis. | Posted | Least Squares Mean | Standard Error | Kcals | 12 months |
|
|
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| Secondary | Change in Weekly Moderate to Vigorous Physical Activity (MVPA) | 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. | Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis. | Posted | Least Squares Mean | Standard Error | min/wk | 12 months |
|
|
|
| 0 |
| 121 |
| 1 |
| 121 |
| 0 |
| 121 |
| EG001 | 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. | 0 | 122 | 0 | 122 | 0 | 122 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |