A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Binge eating episodes
研究概览
简要总结
The proposed study is an open label, non randomized, waitlist controlled single group feasibility study of the feasibility and usability of a digital intervention (called ChangeBite) to be used by individuals with obesity and comorbid binge eating behavior. The proposed research will include approximately 30 participants. Participants will be recruited for this single group pilot trial using online advertising to attend a virtual screening session. Screened participants willing and eligible to participate, will receive informed consent and formally start ChangeBite. Participants will be instructed to engage with ChangeBite and attend follow up assessments on scheduled video calls. Feasibility and acceptability of implementation will be assessed by collecting data on recruitment, retention, usability and satisfaction. The research team will also collect assessment data from participants on feasibility, and usability. In addition to self report scales, semi-structured interviews will be completed with a trained research team member via video call and will be partially recorded. Assessments will be done at baseline, 12 weeks, and 24 weeks. Participants' app use frequency and duration will be tracked using software analytics. Participants' body weight will be captured weekly using a timestamped picture of their weight as it appears on their scale and Body Mass Index will be calculated with these data points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Are English speaking male or female
- •Are aged 18-70 years
- •Have recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months)
- •Have BMI ≥30
- •Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
- •Are willing and able to complete enrollment procedures
- •Are able to understand the nature of the study and provide written informed consent
排除标准
- •Are unable to fluently speak, write and read English.
- •Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider)
- •Are receiving weight loss treatment (behavioral or pharmacological)
- •Have a mental handicap or are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., imminent or high risk for suicide, substance use disorder, active psychotic disorder,)
- •Are purging and/or using laxatives 3 or more times per week and are not deemed safe for remote treatment by a primary care provider.
- •Are exercising 2 or more hours a day on average, or engaging in significantly harmful compensatory behaviors (i.e., > 3x/week of self-induced vomiting or laxative use), and are not deemed safe for remote treatment by a primary care provider.
- •Are fasting for 24 hours or more, > 3x times a week, and are not deemed safe for remote treatment by a primary care provider.
- •Are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate.
- •Are pregnant or planning to become pregnant within the next year.
- •Are individuals who are not yet adults (infants, children, teenagers) Are currently taking any of these medications: Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, Zyprexa
- •Are adults unable to consent
- •Are prisoners
研究组 & 干预措施
Self-Help Digital Intervention
All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.
干预措施: Digital (Other)
结局指标
主要结局
Binge eating episodes
时间窗: 3 months
The frequency of binge eating episodes.
Weight
时间窗: 3 months
Weight loss during the intervention.
次要结局
未报告次要终点