Treating Binge Eating and Obesity Digitally in Women: A Feasibility Study (LISTEN Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Attendance: Percentage of Intervention Sessions Attended
研究概览
简要总结
More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.
详细描述
Aim 1. Modify and adapt a validated program to be a culturally-relevant digital health tool for binge eating and weight management for Black women (BMI > 30 kg/m^2) who binge eat.
Aim 1a. Identify the barriers and facilitators to detecting and treating binge eating in Black women with obesity, and identify strategies for optimizing digital health tools to engage and retain this population.
Aim 1b. Conduct usability testing with a group of stakeholders to guide content and design refinements; refine tool.
Aim 2. In a randomized clinical trial, examine the feasibility and preliminary efficacy of the digital health appetite awareness + behavioral weight program in primary care.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age with pre-diabetes,
- •Have an (A1c between 5.7%-6.4%),
- •BMI ≥ 30 kg/m^2,
- •have and regularly use a Bluetooth-enabled smartphone,
- •report at least one binge eating episode weekly,
- •work or live within 30 miles of Kannapolis, NC,
- •Have not used prescription weight loss medications (like Wegovy, Zepbound, or Ozempic) in the past 3 months
排除标准
- •currently pregnant,
- •Are currently taking or have taken within the prior 3 months (12 weeks) a GLP-1,
- •in substance abuse treatment,
- •involved in another weight reduction program,
- •have a history of anorexia,
- •are purging,
- •currently in treatment for eating difficulties,
- •are concurrent intravenous drug users
- •consume >4 alcoholic beverages/day
研究组 & 干预措施
Centering Appetite Intervention, Then Attention- Control Group
Participants randomized to the attention-control group will participate remotely via a smartphone app and online lessons. The intervention will build participants' self-efficacy to reduce binge eating and to assist them in preventing weight gain.
干预措施: Centering Appetite (Behavioral)
Attention- Control Group, Then Centering Appetite Intervention
Participants randomized to the centering appetite intervention group will receive weekly psychoeducation emails about general wellness topics, discussion of binge eating, diet, and physical activity.
结局指标
主要结局
Attendance: Percentage of Intervention Sessions Attended
时间窗: 6 months
Percentage of intervention sessions attended for the duration of the study by each participant.
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
时间窗: 3 month
Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.
Retention: Percentage of Participants Retained in the Study
时间窗: 6 months
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
时间窗: 4 month
Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.
次要结局
- Change from Baseline to Month 6 in weight regain(Baseline, 6 months)
- Change in number of Binge Eating Episodes from Baseline to Month 3(Baseline, 3 months)
- Change from Baseline to Month 3 in weight regain(Baseline, 3 months)
- Change in number of Binge Eating Episodes from Baseline to Month 6(Baseline, 6 months)
- Change from Baseline to Month 4 in weight regain(Baseline, 4 months)
- Change in number of Binge Eating Episodes from Baseline to Month 4(Baseline, 4 months)