The Mobile Lifestyle Intervention for Food and Exercise Study

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity; Type2 Diabetes
• Interventions: Behavioral: 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)

• Registration Number: NCT05176847
• Lead Sponsor: University of South Carolina

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. 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.

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 Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-04
• Study Start: 2022-03-01
• Primary Completion: 2024-07-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamified mLIFE app group	Podcasts and tips of the day (within app)	Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
Gamified mLIFE app group	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	mLIFE app (self-regulation 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.
Gamified mLIFE app group	mLIFE app (self-regulation features)	Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
standard mLIFE app	Podcasts and tips of the day (within 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.
standard mLIFE app	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.

Primary Outcome Measures

Name	Time	Method
Change in body weight	12 months	Change in body weight from baseline to 12 months as assessed digitally

Secondary Outcome Measures

Name	Time	Method
Change in Kcals consumed a day	12 months	Change in Kcal from baseline to 12 months as assessed via dietary recalls
Change in minutes a week of moderate to vigorous physical activity (MVPA)	12 months	Change in minutes a week of MVPA from baseline to 12 months as assessed via accelerometer

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States