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NCT05176847: mLIFE

The Mobile Lifestyle Intervention for Food and Exercise Study

Completed NA Results posted Last updated 15 January 2026
What this trial tests

NA trial testing Podcasts and tips of the day (within app) in Overweight and Obesity in 243 participants. Completed in 30 September 2025.

Timeline
1 March 2022
Primary endpoint
12 July 2024
30 September 2025

Quick facts

Lead sponsorUniversity of South Carolina
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment243
Start date1 March 2022
Primary completion12 July 2024
Estimated completion30 September 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of South Carolina

Who can join

Adults 18 to 65, any sex, with Overweight and Obesity or Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Body Weight Primary · 12 months

Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.

GroupValue95% CI
Gamified mLIFE App Group-5.3± 0.64
Standard mLIFE App-3.49± 0.72
Change in Energy Intake Secondary · 12 months

Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake.

GroupValue95% CI
Gamified mLIFE App Group-347.73± 91.15
Standard mLIFE App-257.42± 92.93
Change in Weekly Moderate to Vigorous Physical Activity (MVPA) Secondary · 12 months

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.

GroupValue95% CI
Gamified mLIFE App Group-4.66± 23.45
Standard mLIFE App-3.5± 24.91

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until end of study, up to 52 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gamified mLIFE App Group
Serious: 1/121 (1%)
Deaths: 0/121
Standard mLIFE App
Serious: 0/122 (0%)
Deaths: 0/122

Serious adverse events (1 terms)

ReactionSystemGamified mLIFE App GroupStandard mLIFE App
Neck injury due to fallMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Neck injury due to fall.

Data from ClinicalTrials.gov NCT05176847 adverse events section.

Sponsor's own description

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: 1. 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. 2. Examine the differences in social support provision and receipt between groups at 12 months.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity.
    Metzendorf MI, Wieland LS, Richter B. · · 2024 · cited 28× · PMID 38375882 · DOI 10.1002/14651858.cd013591.pub2
  2. The mLIFE randomized trial examining the impact of gamifying social support provision for weight loss.
    Turner-McGrievy GM, Delgado-Díaz DC, DuBois KE, Aydin HZ, et al · · 2025 · cited 2× · PMID 40629523 · DOI 10.1002/oby.24330
  3. 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.
    DuBois KE, Delgado-Díaz DC, McGrievy M, Valafar H, et al · · 2025 · cited 2× · PMID 39522630 · DOI 10.1016/j.cct.2024.107735
  4. 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.
    Turner-McGrievy G, Monroe C, Delgado-Diaz C, Aydin HZ, et al · · 2026 · PMID 41498406 · DOI 10.1093/tbm/ibaf086

Verify or expand the search:

Other recruiting trials for Overweight and Obesity

Currently open trials in the same condition.

Other University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05176847.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing