Overweight and Obesity, Type2 Diabetes
Conditions
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.
Interventions
BEHAVIORALPodcasts and tips of the day (within app)
Participants will receive twice weekly podcasts and daily tips of the day, with nutrition and exercise information, audio diary and goal setting.
BEHAVIORALmLIFE app (self-regulation features)
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.
BEHAVIORALmLIFE app (social support features)
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.
BEHAVIORALstandard mLIFE app (social support features)
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 12 months | Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy Intake | 12 months | Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake. |
| Change in Weekly Moderate to Vigorous Physical Activity (MVPA) | 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. |
Countries
United States
Participant flow
Recruitment details
The mLife study was a 52-week parallel group randomized behavioral intervention conducted with two sequential cohorts. Recruitment was implemented through targeted advertisements on social media platforms (Facebook and Instagram) and ResearchMatch, directing prospective participants to a study website for eligibility screening. Eligible individuals completed a phone screener and attended a virtual orientation to review procedures and provide informed consent. Recruitment occurred Feb 18-May 20,
Pre-assignment details
Eligible and interested participants were offered a choice of orientation session times. During the session, the study coordinator provided a comprehensive overview of the study, addressed participant questions, and obtained informed consent. Participants were guided in establishing Fitbit accounts, synchronizing physical activity and weight trackers, and completing baseline assessments. Those who successfully completed baseline procedures were subsequently randomized.
Participants by arm
| Arm | Count |
|---|---|
| Gamified mLIFE App Group Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app. | 121 |
| Standard 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. | 122 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 36 |
| Overall Study | Removed from analysis | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 12 |
Baseline characteristics
| Characteristic | Standard mLIFE App | Gamified mLIFE App Group | Total |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 1 | 47.0 years STANDARD_DEVIATION 1 | 46.7 years STANDARD_DEVIATION 1 |
| Body weight, | 104.4 kg STANDARD_DEVIATION 2.4 | 106.8 kg STANDARD_DEVIATION 2.4 | 105.6 kg STANDARD_DEVIATION 2.4 |
| Energy intake | 2073.91 kcal/d STANDARD_DEVIATION 80.1 | 2136.24 kcal/d STANDARD_DEVIATION 79.64 | 2105.08 kcal/d STANDARD_DEVIATION 79.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 110 Participants | 220 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Physical Activity | 220.27 minutes/wk STANDARD_DEVIATION 43.19 | 261.12 minutes/wk STANDARD_DEVIATION 45.1 | 238.0 minutes/wk STANDARD_DEVIATION 44.1 |
| Sex: Female, Male Female | 112 Participants | 107 Participants | 219 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 122 |
| other Total, other adverse events | 0 / 121 | 0 / 122 |
| serious Total, serious adverse events | 1 / 121 | 0 / 122 |
Outcome results
Primary
Change in Body Weight
Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.
Time frame: 12 months
Population: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gamified mLIFE App Group | Change in Body Weight | -5.3 Kg | Standard Error 0.64 |
| Standard mLIFE App | Change in Body Weight | -3.49 Kg | Standard Error 0.72 |
p-value: 0.0995% CI: [-3.71, 0.09]Mixed Models Analysis
Secondary
Change in Energy Intake
Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake.
Time frame: 12 months
Population: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gamified mLIFE App Group | Change in Energy Intake | -347.73 Kcals | Standard Error 91.15 |
| Standard mLIFE App | Change in Energy Intake | -257.42 Kcals | Standard Error 92.93 |
Secondary
Change in Weekly Moderate to Vigorous Physical Activity (MVPA)
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.
Time frame: 12 months
Population: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Gamified mLIFE App Group | Change in Weekly Moderate to Vigorous Physical Activity (MVPA) | -4.66 min/wk | Standard Error 23.45 |
| Standard mLIFE App | Change in Weekly Moderate to Vigorous Physical Activity (MVPA) | -3.5 min/wk | Standard Error 24.91 |