Trial Outcomes & Findings for The Mobile Lifestyle Intervention for Food and Exercise Study (NCT NCT05176847)
NCT ID: NCT05176847
Last Updated: 2026-01-15
Results Overview
Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.
COMPLETED
NA
243 participants
12 months
2026-01-15
Participant Flow
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,
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.
Participant milestones
| Measure |
Gamified mLIFE App Group
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
122
|
|
Overall Study
COMPLETED
|
90
|
74
|
|
Overall Study
NOT COMPLETED
|
31
|
48
|
Reasons for withdrawal
| Measure |
Gamified mLIFE App Group
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
36
|
|
Overall Study
Withdrawal by Subject
|
7
|
12
|
|
Overall Study
Removed from analysis
|
1
|
0
|
Baseline Characteristics
Age at baseline assessment
Baseline characteristics by cohort
| Measure |
Gamified mLIFE App Group
n=121 Participants
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
Standard mLIFE App
n=122 Participants
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.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 1.0 • n=9 Participants • Age at baseline assessment
|
46.4 years
STANDARD_DEVIATION 1.0 • n=6 Participants • Age at baseline assessment
|
46.7 years
STANDARD_DEVIATION 1.0 • n=9 Participants • Age at baseline assessment
|
|
Sex: Female, Male
Female
|
107 Participants
n=9 Participants
|
112 Participants
n=6 Participants
|
219 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=9 Participants
|
110 Participants
n=6 Participants
|
220 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Body weight,
|
106.8 kg
STANDARD_DEVIATION 2.4 • n=9 Participants
|
104.4 kg
STANDARD_DEVIATION 2.4 • n=6 Participants
|
105.6 kg
STANDARD_DEVIATION 2.4 • n=9 Participants
|
|
Energy intake
|
2136.24 kcal/d
STANDARD_DEVIATION 79.64 • n=9 Participants
|
2073.91 kcal/d
STANDARD_DEVIATION 80.1 • n=6 Participants
|
2105.08 kcal/d
STANDARD_DEVIATION 79.9 • n=9 Participants
|
|
Physical Activity
|
261.12 minutes/wk
STANDARD_DEVIATION 45.1 • n=9 Participants
|
220.27 minutes/wk
STANDARD_DEVIATION 43.19 • n=6 Participants
|
238.0 minutes/wk
STANDARD_DEVIATION 44.1 • n=9 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.
Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.
Outcome measures
| Measure |
Gamified mLIFE App Group
n=121 Participants
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
Standard mLIFE App
n=122 Participants
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.
|
|---|---|---|
|
Change in Body Weight
|
-5.3 Kg
Standard Error 0.64
|
-3.49 Kg
Standard Error 0.72
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.
Difference in total energy intake between follow-up and baseline (follow-up - baseline); positive values indicate increased intake.
Outcome measures
| Measure |
Gamified mLIFE App Group
n=121 Participants
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
Standard mLIFE App
n=122 Participants
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.
|
|---|---|---|
|
Change in Energy Intake
|
-347.73 Kcals
Standard Error 91.15
|
-257.42 Kcals
Standard Error 92.93
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.
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.
Outcome measures
| Measure |
Gamified mLIFE App Group
n=121 Participants
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
Standard mLIFE App
n=122 Participants
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.
|
|---|---|---|
|
Change in Weekly Moderate to Vigorous Physical Activity (MVPA)
|
-4.66 min/wk
Standard Error 23.45
|
-3.5 min/wk
Standard Error 24.91
|
Adverse Events
Gamified mLIFE App Group
Standard mLIFE App
Serious adverse events
| Measure |
Gamified mLIFE App Group
n=121 participants at risk
Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.
|
Standard mLIFE App
n=122 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck injury due to fall
|
0.83%
1/121 • Number of events 1 • From enrollment until end of study, up to 52 weeks.
|
0.00%
0/122 • From enrollment until end of study, up to 52 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place