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Completed

NCT Number: NCT05176847

The Mobile Lifestyle Intervention for Food and Exercise Study

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2 Diabetes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Change in Body Weight

    Time frame: 12 months

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

Secondary outcomes

  1. Change in Energy Intake

    Time frame: 12 months

    Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake.

  2. Change in Weekly Moderate to Vigorous Physical Activity (MVPA)

    Time frame: 12 months

    Difference in average weekly minutes of moderate-to-vigorous physical activity (MVPA) between follow-up and baseline (follow-up - baseline), derived from Fitbit physical activity data; positive values indicate increased MVPA.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: The Mobile Intervention for Food and Exercise (mLIFE) Study

Acronym: mLIFE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 4, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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