Obesity
Conditions
Keywords
weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth
Brief summary
The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALStandard mHealth intervention (mHealth)
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-75 * BMI between 25-55kg/m2 * All sexes * All racial/ethnic groups * Low SES and/or report qualifying for federal, state or local benefits * Have a smartphone and willing to use for research purposes
Exclusion criteria
* \<18-75\>years of age * Report being unable to walk 2 blocks without stopping * Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months * Are pregnant or plan to become pregnant within 1 year * Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire * Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines * Have diabetes and are on insulin * Report a medical condition that could jeopardize their safety in a weight loss program with diet and exercise guidelines * Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English) * Report unable to read and write English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline, 2 month, 6 month, 12 month, 18 months | Weight change measured on a digital scale to the nearest 0.1-kilogram |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| 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). | 98 |
| Total | 195 |
Baseline characteristics
| Characteristic | Total | Behavioral Economics Intervention (BE mHealth) | Standard mHealth Intervention (mHealth) |
|---|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 15.1 | 37.6 years STANDARD_DEVIATION 12.8 | 42.0 years STANDARD_DEVIATION 16.9 |
| Body Mass Index (BMI; kg/m2) | 35.2 kg/m2 STANDARD_DEVIATION 6.8 | 35.7 kg/m2 STANDARD_DEVIATION 7.1 | 34.7 kg/m2 STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 148 Participants | 71 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 25 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants | 33 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) White | 83 Participants | 36 Participants | 47 Participants |
| Sex/Gender, Customized Gender Female | 168 Participants | 84 Participants | 84 Participants |
| Sex/Gender, Customized Gender Male | 26 Participants | 13 Participants | 13 Participants |
| Sex/Gender, Customized Gender Non-binary | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 98 |
| other Total, other adverse events | 7 / 97 | 5 / 98 |
| serious Total, serious adverse events | 3 / 97 | 6 / 98 |
Outcome results
Primary
Weight
Weight change measured on a digital scale to the nearest 0.1-kilogram
Time frame: Baseline, 2 month, 6 month, 12 month, 18 months
Population: There was attrition over time during this longitudinal study, such that more participants were lost to follow-up over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Economics Intervention (BE mHealth) | Weight | Baseline | 98.2 kg | Standard Deviation 24.5 |
| Behavioral Economics Intervention (BE mHealth) | Weight | 2 month | 95.3 kg | Standard Deviation 23.9 |
| Behavioral Economics Intervention (BE mHealth) | Weight | 6 month | 93.9 kg | Standard Deviation 23.6 |
| Behavioral Economics Intervention (BE mHealth) | Weight | 12 month | 94.9 kg | Standard Deviation 24.9 |
| Behavioral Economics Intervention (BE mHealth) | Weight | 18 month | 94.1 kg | Standard Deviation 24.7 |
| Standard mHealth Intervention (mHealth) | Weight | 18 month | 90.9 kg | Standard Deviation 20.7 |
| Standard mHealth Intervention (mHealth) | Weight | Baseline | 93.5 kg | Standard Deviation 19.1 |
| Standard mHealth Intervention (mHealth) | Weight | 12 month | 89.3 kg | Standard Deviation 21 |
| Standard mHealth Intervention (mHealth) | Weight | 2 month | 91.6 kg | Standard Deviation 19.5 |
| Standard mHealth Intervention (mHealth) | Weight | 6 month | 90.2 kg | Standard Deviation 20.5 |