Binge Eating, Weight Gain Prevention, Weight Loss
Conditions
Brief summary
The purpose of the proposed study is to pilot a 6-month, cognitive-behavioral binge eating intervention, Appetite Awareness Training (AAT) to reduce binge eating and prevent weight gain for Black women with a BMI \> 25 kg/m\^2 and with weekly binge eating episodes. Intervention participants will receive a 8-week group AAT intervention, and will also receive bluetooth-connected scales for daily weighing. Participants will also receive tailored feedback on self-weighing frequency and weight change. The investigators will follow-up with participants at six months.
Detailed description
Aim 1. Using an experimental design, examine the feasibility and acceptability of 6-month AAT (N=40) in North Carolina. Forty overweight and obese (BMI ≥ 25 kg/m\^2) community-based Black women will be randomized to the AAT intervention or wait-list control (who will eventually receive the intervention). AAT participants will meet weekly for 8 weeks, followed by a 4-month period of daily weighing and weekly tailored feedback only. The study will examine the following: recruitment feasibility, attendance/retention, adherence, satisfaction, and barriers to completion. Aim 2: At 4 and 6 months, compare changes in (a) binge eating, eating self-efficacy, and depressive symptoms and (b) weight, blood pressure, and waist circumference for participants in the intervention vs. control group. H\_1: Participants in the AAT intervention will report less binge and overeating and gain less weight than those in the control group at 2 and 6 months. Secondary aim: Examine characteristics (e.g., baseline BMI, severity of binge eating, frequency of self-weighing) related to change in binge eating and weight.
Interventions
BEHAVIORALAppetite Awareness Treatment + Lifestyle Modification
The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The proposed study will use a randomized clinical trial design. A sample of 40 black women who report at least weekly binge eating episodes will be randomized to 2 arms of a 6-month AAT intervention: AAT or a wait-list control group (delayed intervention group). AAT participants will receive an 8-week AAT program using a group format, and will be provided a smart scale (with bluetooth-connection for automatic data reporting) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessments will be conducted at 0, 2, and 6 months.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Individuals are eligible if they are: * non-Latino Black women, * over 18 years of age, * have a BMI ≥ 25kg/m\^2, * use a Bluetooth-enabled smartphone, * report at least one binge eating episode weekly, and * complete the screening.
Exclusion criteria
Individuals will be excluded if they: * are currently pregnant, * are in substance abuse treatment, * are involved in another weight reduction program, * have a history of anorexia, * are purging, * are currently in treatment for eating difficulties, * are concurrent intravenous drug users or consume \>4 alcoholic beverages/day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study | Month 6 | Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study. |
| Feasibility (Retention): Percentage of Participants Retained in the Study | Month 6 | Percentage of participants retained in the study following enrollment through month 6 |
| Feasibility (Attendance): Percentage of Sessions That Were Attended | Month 2 | Each session attended by participants was captured. The number of sessions attended for each participant were summed and then divided by the number of total participants and multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Binge Eating Scale Score From Baseline to Month 6 | Baseline, Month 6 | This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome. |
| Median Weight Change From Baseline to Month 4 | Baseline, Month 4 | Measured in Kg |
| Mean Objective Binge Eating Episodes | up to 6 months | Participants were administered the interviewer-based overeating section of the Eating Disorder Examination (EDE) to assess objective binge eating episodes (OBE) (i.e., consumption of an objectively large amount of food and loss of control over eating) within the 28 days prior. Assessed at Baseline, Month 4, and Month 6. |
| Median Weight Change From Baseline to Month 6 | Baseline, Month 6 | Measured in Kg |
| Mean Change in Binge Eating Scale Score From Baseline to Month 2 | Baseline, Month 2 | This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in individuals with overweight and obesity. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome. |
Countries
United States
Participant flow
Pre-assignment details
Study terminated prior to enrollment of control participants.
Participants by arm
| Arm | Count |
|---|---|
| Appetite Awareness Treatment + Lifestyle Modification Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms. | 20 |
| Control Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment. | 0 |
| Total | 20 |
Baseline characteristics
| Characteristic | Appetite Awareness Treatment + Lifestyle Modification | Total |
|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 13.8 | 46.4 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 0 |
| other Total, other adverse events | 0 / 20 | 0 / 0 |
| serious Total, serious adverse events | 0 / 20 | 0 / 0 |
Outcome results
Primary
Feasibility (Attendance): Percentage of Sessions That Were Attended
Each session attended by participants was captured. The number of sessions attended for each participant were summed and then divided by the number of total participants and multiplied by 100.
Time frame: Month 2
Population: Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Feasibility (Attendance): Percentage of Sessions That Were Attended | 56 percentage of sessions per participant |
Primary
Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time frame: Month 6
Population: Study terminated prior to enrollment of control participants. The number of potential participants screened for study eligibility
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study | 20 Participants |
Primary
Feasibility (Retention): Percentage of Participants Retained in the Study
Percentage of participants retained in the study following enrollment through month 6
Time frame: Month 6
Population: Study terminated prior to enrollment of control participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Feasibility (Retention): Percentage of Participants Retained in the Study | 85 percentage of participants |
Secondary
Mean Change in Binge Eating Scale Score From Baseline to Month 2
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in individuals with overweight and obesity. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Time frame: Baseline, Month 2
Population: Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination
Secondary
Mean Change in Binge Eating Scale Score From Baseline to Month 6
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Time frame: Baseline, Month 6
Population: Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination
Secondary
Mean Objective Binge Eating Episodes
Participants were administered the interviewer-based overeating section of the Eating Disorder Examination (EDE) to assess objective binge eating episodes (OBE) (i.e., consumption of an objectively large amount of food and loss of control over eating) within the 28 days prior. Assessed at Baseline, Month 4, and Month 6.
Time frame: up to 6 months
Population: Study terminated prior to enrollment of control participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Mean Objective Binge Eating Episodes | Month 4 | 2.1 binge eating episodes | Standard Deviation 5.1 |
| Appetite Awareness Treatment + Lifestyle Modification | Mean Objective Binge Eating Episodes | Month 6 | 2.6 binge eating episodes | Standard Deviation 6.9 |
| Appetite Awareness Treatment + Lifestyle Modification | Mean Objective Binge Eating Episodes | Baseline | 6.5 binge eating episodes | Standard Deviation 7.8 |
Secondary
Median Weight Change From Baseline to Month 4
Measured in Kg
Time frame: Baseline, Month 4
Population: Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Median Weight Change From Baseline to Month 4 | 0 Kg |
Secondary
Median Weight Change From Baseline to Month 6
Measured in Kg
Time frame: Baseline, Month 6
Population: Study terminated prior to enrollment of control participants. Data not included for seven participants who discontinued.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Median Weight Change From Baseline to Month 6 | -0.2 Kg |