The Mobile Lifestyle Intervention for Food and Exercise Study (mLIFE)
Primary Purpose
Overweight and Obesity, Type2 Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Podcasts and tips of the day (within app)
mLIFE app (self-regulation features)
mLIFE app (social support features)
standard mLIFE app (social support features)
Sponsored by

About this trial
This is an interventional prevention trial for Overweight and Obesity
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
Sites / Locations
- University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gamified mLIFE app group
standard mLIFE app
Arm Description
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE 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.
Outcomes
Primary Outcome Measures
Change in body weight
Change in body weight from baseline to 12 months as assessed digitally
Secondary Outcome Measures
Change in Kcals consumed a day
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)
Change in minutes a week of MVPA from baseline to 12 months as assessed via accelerometer
Full Information
NCT ID
NCT05176847
First Posted
December 16, 2021
Last Updated
June 22, 2023
Sponsor
University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05176847
Brief Title
The Mobile Lifestyle Intervention for Food and Exercise Study
Acronym
mLIFE
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Type2 Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gamified mLIFE app group
Arm Type
Experimental
Arm Description
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
Arm Title
standard mLIFE app
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Podcasts and tips of the day (within app)
Intervention Description
Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
Intervention Type
Behavioral
Intervention Name(s)
mLIFE app (self-regulation features)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mLIFE app (social support features)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standard mLIFE app (social support features)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Change in body weight from baseline to 12 months as assessed digitally
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Kcals consumed a day
Description
Change in Kcal from baseline to 12 months as assessed via dietary recalls
Time Frame
12 months
Title
Change in minutes a week of moderate to vigorous physical activity (MVPA)
Description
Change in minutes a week of MVPA from baseline to 12 months as assessed via accelerometer
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brie Turner-Mcgrievy
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Mobile Lifestyle Intervention for Food and Exercise Study
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