Obesity, Binge Eating
Conditions
Brief summary
The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.
Interventions
BEHAVIORALBehavioral weight loss
Participants will receive behavioral weight loss intervention
BEHAVIORALIntervention component: Decrease overvaluation of weight and shape
Participants will receive an intervention component to decrease overvaluation of weight and shape
BEHAVIORALIntervention component: Decrease unhealthy weight control practices
Participants will receive an intervention component to decrease unhealthy weight control practices
BEHAVIORALIntervention component: Decrease negative affect
Participants will receive an intervention component to decrease negative affect
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 years or older * Obesity (BMI ≥30) * Recurrent binge eating (≥12 episodes in the past 3 months) * 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 * Has access to a scale * Not pregnant * English-speaking
Exclusion criteria
* Diagnosis for which the study/intervention is not clinically indicated * Not currently receiving clinical services for weight management or binge eating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Measured at baseline, post-intervention (16-weeks) | Changes in weight |
| Binge Eating Episodes | Measured at baseline, post-intervention (16-weeks) | Changes in episodes of binge eating (past 28 days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Condition 1 Behavioral weight loss intervention
Behavioral weight loss: Participants will receive behavioral weight loss intervention | 10 |
| Condition 2 Behavioral weight loss intervention and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 10 |
| Condition 3 Behavioral weight loss intervention and decrease unhealthy weight control practices
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices | 10 |
| Condition 4 Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 10 |
| Condition 5 Behavioral weight loss intervention and decrease overvaluation of weight and shape
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape | 11 |
| Condition 6 Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 10 |
| Condition 7 Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices | 10 |
| Condition 8 Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect
Behavioral weight loss: Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 10 |
| Total | 81 |
Baseline characteristics
| Characteristic | Condition 1 | Condition 2 | Condition 3 | Condition 4 | Condition 5 | Condition 6 | Condition 7 | Condition 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 17.6 | 36.9 years STANDARD_DEVIATION 12.5 | 49.5 years STANDARD_DEVIATION 10.7 | 37.5 years STANDARD_DEVIATION 18.2 | 48.1 years STANDARD_DEVIATION 15.3 | 41.2 years STANDARD_DEVIATION 13.5 | 42.1 years STANDARD_DEVIATION 15.5 | 47.3 years STANDARD_DEVIATION 17.3 | 43.4 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 7 Participants | 7 Participants | 10 Participants | 7 Participants | 9 Participants | 9 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 8 Participants | 4 Participants | 4 Participants | 5 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 6 Participants | 4 Participants | 2 Participants | 4 Participants | 6 Participants | 4 Participants | 35 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 8 Participants | 7 Participants | 10 Participants | 6 Participants | 7 Participants | 8 Participants | 62 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 4 Participants | 3 Participants | 2 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Binge Eating Episodes
Changes in episodes of binge eating (past 28 days)
Time frame: Measured at baseline, post-intervention (16-weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overvaluation of Weight/Shape (Yes) | Binge Eating Episodes | 8.1 Change in number of episodes | Standard Deviation 10.9 |
| Overvaluation of Weight/Shape (no) | Binge Eating Episodes | 10.1 Change in number of episodes | Standard Deviation 13.7 |
| Unhealthy Weight Control Practices (Yes) | Binge Eating Episodes | 6.9 Change in number of episodes | Standard Deviation 8.5 |
| Unhealthy Weight Control Practices (no) | Binge Eating Episodes | 11.2 Change in number of episodes | Standard Deviation 15 |
| Negative Affect (Yes) | Binge Eating Episodes | 9.8 Change in number of episodes | Standard Deviation 11.1 |
| Negative Affect (no) | Binge Eating Episodes | 8.4 Change in number of episodes | Standard Deviation 13.5 |
Primary
Weight
Changes in weight
Time frame: Measured at baseline, post-intervention (16-weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overvaluation of Weight/Shape (Yes) | Weight | 4.2 pounds | Standard Deviation 21.9 |
| Overvaluation of Weight/Shape (no) | Weight | 6.9 pounds | Standard Deviation 21.3 |
| Unhealthy Weight Control Practices (Yes) | Weight | 4.7 pounds | Standard Deviation 22.6 |
| Unhealthy Weight Control Practices (no) | Weight | 6.3 pounds | Standard Deviation 20.7 |
| Negative Affect (Yes) | Weight | 8.5 pounds | Standard Deviation 27.7 |
| Negative Affect (no) | Weight | 2.7 pounds | Standard Deviation 12.6 |