Overweight and ObesitymLIFENCT05176847
The Mobile Lifestyle Intervention for Food and Exercise Study
A study testing Podcasts and tips of the day (within app), mLIFE app (self-regulation features) and mLIFE app (social support features) in people with Overweight and Obesity and Type2 Diabetes, run by University of South Carolina at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Type2 Diabetes
- What is being tested?
- Podcasts and tips of the day (within app), mLIFE app (self-regulation features) and mLIFE app (social support features)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Type2 Diabetes
- Being tested
- Podcasts and tips of the day (within app), mLIFE app (self-regulation features), mLIFE app (social support features), standard mLIFE app (social support features)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podcasts and tips of the day (within app)Behavioural
Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
mLIFE app (self-regulation features)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Podcasts and tips of the day (within app); Behavioral: mLIFE app (self-regulation features); Behavioral: mLIFE app (social support features) |
| 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. Receives: Behavioral: Podcasts and tips of the day (within app); Behavioral: mLIFE app (self-regulation features); Behavioral: standard mLIFE app (social support features) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.
Measured: 12 months
Secondary outcomes (2)
Change in Energy Intake
Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Mar 2022
- Primary completion12 Jul 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie Turner-Mcgrievy, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176847
- Sponsor's protocol ID
- Pro00109784
- Other IDs
- 1R01DK129302
- Acronym
- mLIFE
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2021
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41498406DuBois 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.
PubMed 39522630
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: The Mobile Intervention for Food and Exercise (mLIFE) Study
- ClinicalTrials.gov ID
- NCT05176847
- Acronym / sponsor ID
- mLIFE / Pro00109784
- Conditions
- Overweight and Obesity, Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 15 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamified mLIFE app group | Experimental | Behavioral: Podcasts and tips of the day (within app), Behavioral: mLIFE app (self-regulation features), Behavioral: mLIFE app (social support features)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 | Behavioral: Podcasts and tips of the day (within app), Behavioral: mLIFE app (self-regulation features), Behavioral: standard mLIFE app (social support features)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Podcasts and tips of the day (within app)Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting. | Behavioural | Gamified mLIFE app group, standard mLIFE app |
| mLIFE app (self-regulation features)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. | Behavioural | Gamified mLIFE app group, standard mLIFE app |
| mLIFE app (social support features)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. | Behavioural | Gamified mLIFE app group |
| standard mLIFE app (social support features)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. | Behavioural | standard mLIFE app |
Primary outcome
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.
2 secondary outcomes
Change in Energy Intake
Time frame: 12 months
Change in Weekly Moderate to Vigorous Physical Activity (MVPA)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41498406Turner-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.
- Derived from this study: PubMed 39522630DuBois 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brie Turner-Mcgrievy principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podcasts and tips of the day (within app), mLIFE app (self-regulation features) and mLIFE app (social support features) in people with Overweight and Obesity and Type2 Diabetes, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05176847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.