Trial Outcomes & Findings for Research Intervention to Support Healthy Eating and Exercise (NCT NCT04353258)
NCT ID: NCT04353258
Last Updated: 2026-01-09
Results Overview
Weight change measured on a digital scale to the nearest 0.1-kilogram
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
Baseline, 2 month, 6 month, 12 month, 18 months
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Behavioral Economics Intervention (BE mHealth)
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
|
Standard mHealth Intervention (mHealth)
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
|
Overall Study
COMPLETED
|
83
|
85
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research Intervention to Support Healthy Eating and Exercise
Baseline characteristics by cohort
| Measure |
Behavioral Economics Intervention (BE mHealth)
n=97 Participants
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
|
Standard mHealth Intervention (mHealth)
n=98 Participants
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 12.8 • n=8 Participants
|
42.0 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 15.1 • n=15 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
84 Participants
n=8 Participants
|
84 Participants
n=7 Participants
|
168 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
13 Participants
n=8 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Gender · Non-binary
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
71 Participants
n=8 Participants
|
77 Participants
n=7 Participants
|
148 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=8 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=8 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=8 Participants
|
47 Participants
n=7 Participants
|
83 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=15 Participants
|
|
Body Mass Index (BMI; kg/m2)
|
35.7 kg/m2
STANDARD_DEVIATION 7.1 • n=8 Participants
|
34.7 kg/m2
STANDARD_DEVIATION 6.5 • n=7 Participants
|
35.2 kg/m2
STANDARD_DEVIATION 6.8 • n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 month, 6 month, 12 month, 18 monthsPopulation: There was attrition over time during this longitudinal study, such that more participants were lost to follow-up over time.
Weight change measured on a digital scale to the nearest 0.1-kilogram
Outcome measures
| Measure |
Behavioral Economics Intervention (BE mHealth)
n=95 Participants
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
|
Standard mHealth Intervention (mHealth)
n=97 Participants
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
|
|---|---|---|
|
Weight
18 month
|
94.1 kg
Standard Deviation 24.7
|
90.9 kg
Standard Deviation 20.7
|
|
Weight
Baseline
|
98.2 kg
Standard Deviation 24.5
|
93.5 kg
Standard Deviation 19.1
|
|
Weight
2 month
|
95.3 kg
Standard Deviation 23.9
|
91.6 kg
Standard Deviation 19.5
|
|
Weight
6 month
|
93.9 kg
Standard Deviation 23.6
|
90.2 kg
Standard Deviation 20.5
|
|
Weight
12 month
|
94.9 kg
Standard Deviation 24.9
|
89.3 kg
Standard Deviation 21.0
|
Adverse Events
Behavioral Economics Intervention (BE mHealth)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard mHealth Intervention (mHealth)
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral Economics Intervention (BE mHealth)
n=97 participants at risk
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
|
Standard mHealth Intervention (mHealth)
n=98 participants at risk
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
2.1%
2/97 • Adverse event data were collected over 12 months.
|
0.00%
0/98 • Adverse event data were collected over 12 months.
|
|
Nervous system disorders
Hospitalization
|
1.0%
1/97 • Adverse event data were collected over 12 months.
|
1.0%
1/98 • Adverse event data were collected over 12 months.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
0.00%
0/97 • Adverse event data were collected over 12 months.
|
1.0%
1/98 • Adverse event data were collected over 12 months.
|
|
Cardiac disorders
Hospitalization
|
0.00%
0/97 • Adverse event data were collected over 12 months.
|
2.0%
2/98 • Adverse event data were collected over 12 months.
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/97 • Adverse event data were collected over 12 months.
|
2.0%
2/98 • Adverse event data were collected over 12 months.
|
Other adverse events
| Measure |
Behavioral Economics Intervention (BE mHealth)
n=97 participants at risk
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Behavioral Economics intervention (BE mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
|
Standard mHealth Intervention (mHealth)
n=98 participants at risk
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Standard mHealth intervention (mHealth): Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID - long/severe
|
2.1%
2/97 • Number of events 2 • Adverse event data were collected over 12 months.
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over 12 months.
|
|
Gastrointestinal disorders
Gall Bladder
|
2.1%
2/97 • Adverse event data were collected over 12 months.
|
0.00%
0/98 • Adverse event data were collected over 12 months.
|
|
Musculoskeletal and connective tissue disorders
Break/Bad Sprain
|
1.0%
1/97 • Adverse event data were collected over 12 months.
|
3.1%
3/98 • Adverse event data were collected over 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/97 • Adverse event data were collected over 12 months.
|
0.00%
0/98 • Adverse event data were collected over 12 months.
|
|
Musculoskeletal and connective tissue disorders
Back issues
|
1.0%
1/97 • Adverse event data were collected over 12 months.
|
0.00%
0/98 • Adverse event data were collected over 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place