Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
时间窗: 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
时间窗: Month 6
Percentage of participants retained in the study following enrollment through month 6
Feasibility (Attendance): Percentage of Sessions That Were Attended
时间窗: 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.
次要结局
- Median Weight Change From Baseline to Month 6(Baseline, Month 6)
- Median Weight Change From Baseline to Month 4(Baseline, Month 4)
- Mean Objective Binge Eating Episodes(up to 6 months)
- Mean Change in Binge Eating Scale Score From Baseline to Month 2(Baseline, Month 2)
- Mean Change in Binge Eating Scale Score From Baseline to Month 6(Baseline, Month 6)