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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK056350 | U.S. NIH Grant/Contract | View source |
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Study terminated due to COVID-19
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM) | Experimental | Participants will receive an 8-week Appetite Awareness Training (AAT) program using a group format, will be provided a smart scale (with bluetooth connection) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessment will be conducted at 0, 2, and 6 months. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Appetite Awareness Treatment + Lifestyle Modification | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Feasibility (Retention): Percentage of Participants Retained in the Study | Percentage of participants retained in the study following enrollment through month 6 | Month 6 |
| 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. | Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Weight Change From Baseline to Month 4 | Measured in Kg | Baseline, Month 4 |
| Median Weight Change From Baseline to Month 6 | Measured in Kg |
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Inclusion Criteria:
Individuals are eligible if they are:
Exclusion Criteria:
Individuals will be excluded if they:
self-identify as a female
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Goode, PhD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition Research Institute | Kannapolis | North Carolina | 28081 | United States |
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Study terminated prior to enrollment of control participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Appetite Awareness Treatment + Lifestyle Modification | Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM): 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study terminated prior to enrollment of control participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study terminated prior to enrollment of control participants. The number of potential participants screened for study eligibility | Posted | Count of Participants | Participants | Month 6 |
|
From the time of Informed Consent through Visit 3, an approximate total of up to 6 months.
Study terminated prior to enrollment of control participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Goode, PhD | University of North Carolina at Chapel Hill | 919-962-6429 | rwgoode@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2018 | Sep 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002032 | Bulimia |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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|
| Baseline, Month 6 |
| 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. | Baseline, Month 2 |
| 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. | Baseline, Month 6 |
| 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. | up to 6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Feasibility (Retention): Percentage of Participants Retained in the Study | Percentage of participants retained in the study following enrollment through month 6 | Study terminated prior to enrollment of control participants. | Posted | Number | percentage of participants | Month 6 |
|
|
|
| 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. | Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued. | Posted | Number | percentage of sessions per participant | Month 2 |
|
|
|
| Secondary | Median Weight Change From Baseline to Month 4 | Measured in Kg | Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued. | Posted | Median | Inter-Quartile Range | Kg | Baseline, Month 4 |
|
|
|
| Secondary | Median Weight Change From Baseline to Month 6 | Measured in Kg | Study terminated prior to enrollment of control participants. Data not included for seven participants who discontinued. | Posted | Median | Inter-Quartile Range | Kg | Baseline, Month 6 |
|
|
|
| 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. | Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination | Posted | Baseline, Month 2 |
|
|
| 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. | Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination | Posted | Baseline, Month 6 |
|
|
| 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. | Study terminated prior to enrollment of control participants. | Posted | Mean | Standard Deviation | binge eating episodes | up to 6 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| Title | Measurements |
|---|---|
|