N/A N=243 Randomized Double-blind Prevention

The Mobile Lifestyle Intervention for Food and Exercise Study

Overweight and Obesity · Type2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT05176847 ↗

Enrolled (actual)

243

Serious AEs

0.4%

Results posted

Jan 2026

Primary outcome: Primary: Change in Body Weight — -5.3; -3.49 Kg — p=0.09

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 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) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of South Carolina
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Body Weight	-5.3; -3.49	0.09
SECONDARY Change in Energy Intake	-347.73; -257.42	—
SECONDARY Change in Weekly Moderate to Vigorous Physical Activity (MVPA)	-4.66; -3.5	—

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) 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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05176847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.