The Mobile Lifestyle Intervention for Food and Exercise Study (mLIFE)

University of South Carolina

Status: Completed

Conditions: Type2 Diabetes; Overweight and Obesity

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05176847

Pro00109784

1R01DK129302 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 243 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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243 participants in 2 patient groups

Gamified mLIFE app group

Experimental group

Description:

Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.

Treatment:

Behavioral: mLIFE app (social support features)

Behavioral: Podcasts and tips of the day (within app)

Behavioral: mLIFE app (self-regulation features)

standard mLIFE app

Active Comparator group

Description:

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.

Treatment:

Behavioral: Podcasts and tips of the day (within app)

Behavioral: standard mLIFE app (social support features)

Behavioral: mLIFE app (self-regulation features)