The Mobile Lifestyle Intervention for Food and Exercise Study

NCT05176847 | Completed Results DMC

• 2 other identifiers: Pro001097841R01DK129302
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight and Obesity; Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

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

  12 months

Secondary Outcomes (2)

• Change in Energy Intake

  12 months

• Change in Weekly Moderate to Vigorous Physical Activity (MVPA)

  12 months

Study Arms (2)

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.

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.

Behavioral: Podcasts and tips of the day (within app); Behavioral: mLIFE app (self-regulation features); Behavioral: standard mLIFE app (social support features)

Interventions

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.

Gamified mLIFE app group; standard mLIFE app

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.

Gamified mLIFE app group; standard mLIFE app

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.

Gamified mLIFE app group

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.

standard mLIFE app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (2)

• 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.

  PMID: 41498406 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.

  PMID: 39522630 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study sample lacked diversity in race/ethnicity and education. Participant attrition was higher than anticipated. Not all potential social support factors were assessed.

Results Point of Contact

• Title: Brie Turner-McGrievy
• Organization: University of South Carolina

brie@sc.edu

8037773932

Study Officials

• Brie Turner-Mcgrievy

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 4, 2022
• Study Start: March 1, 2022
• Primary Completion: July 12, 2024
• Study Completion: September 30, 2025
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2026-01

Locations

US (1)