Binge Eating, Food Insecurity, Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.
Interventions
BEHAVIORALFoodSteps
Participants will get access to the FoodSteps digital intervention with coaching for 16 weeks and receive a weekly stipend benefit to aid with implementing health behavior changes
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 years or older * Recurrent binge eating (≥12 episodes in the past 3 months) * Type 2 diabetes mellitus * Food insecure status (e.g. difficulty accessing food) * Interested in losing weight and reducing binge eating * Willing to use a mobile application * Has a smartphone with Internet access and capacity for calls and text messaging * Has a valid email address * Not pregnant * English-speaking
Exclusion criteria
* Diagnosis for which the study/intervention is not clinically indicated * Currently receiving clinical services for weight management or binge eating * Started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 16 weeks | Feasibility assessed by study recruitment and retention rates |
| Study Retention Rate | 16 weeks | Feasibility assessed by study recruitment and retention rates |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.45 Years STANDARD_DEVIATION 11.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex/Gender, Customized Female | 23 Participants |
| Sex/Gender, Customized Male | 7 Participants |
| Sex/Gender, Customized Not reported as male or female | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
None listed