Clinical trial NCT05176847: The Mobile Lifestyle Intervention for Food and Exercise Study
Official title: Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: the Mobile Intervention for Food and Exercise (mLIFE) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Type2 Diabetes
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in body weight
timeFrame: 12 months
Secondary outcomes:
measure: Change in Kcals consumed a day
timeFrame: 12 months
measure: Change in minutes a week of moderate to vigorous physical activity (MVPA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Brie Turner-Mcgrievy
role: PRINCIPAL_INVESTIGATOR
References: