Targeting Health and Resilience for Individuals With a Vulnerable Eating History (THRIVE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.
详细描述
The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.
The investigators will aim to recruit N=60 pregnant individuals (in their first or second trimester) with histories of an ED. Both the intervention and active control consist of 6, weekly, 1-hour group sessions (6-8 participants per group) delivered over Zoom. There are four assessment points: pre-intervention, post-intervention, 3 months postpartum, and 6 months postpartum. Participants will complete online surveys at each assessment point and a post-intervention exit interview (active intervention only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Within the first or second trimester of pregnancy at enrollment
- •18 years or older
- •Able to provide informed consent
- •Endorse a self-reported history of an eating disorder or disordered eating behaviors
- •Are willing and able to comply with all group and study procedures
- •English fluency and literacy
排除标准
- •A diagnosis of bipolar or psychotic disorder, active mania or psychosis or substance abuse, an active eating disorder (active eating disorder symptomology informed by the Screening, Brief Intervention, and Referral to Treatment for Eating Disorders (SBIRT-ED) tool and clinician discretion), being at immediate risk of self-harm
- •Do not have access to a device with a camera
结局指标
主要结局
Feasibility of recruitment
时间窗: 0 weeks
The investigators will consider the program feasible if the investigators meet recruitment targets (N=60).
Session attendance
时间窗: 6 weeks
The investigators will assess what percentage of enrolled participants complete 4 or more sessions. The benchmark will be \> 50% of participants will complete 4 or more sessions.
Drop Out
时间窗: 6 weeks
The investigators will assess what percentage of enrolled participants complete post-test assessments. The benchmark will be \> 50% of participants will complete the post-test surveys and interviews.
Client satisfaction questionnaire (CSQ-8)
时间窗: 6 weeks
Assesses participants' satisfaction with the intervention. Scores range from 8 to 32 with higher scores indicating greater satisfaction. The benchmark will be that at least 70% of participants will have scores over and above the midpoint in both the PBP and PHE groups.
Credibility and Expectancy Questionnaire (CEQ)
时间窗: 0 weeks
Assesses participants' perceptions that the treatment will work after learning about the study. The first three items measure credibility, and the latter three items measure expectancy. It is scored on a scale of 3-27 with higher scores indicating greater confidence in the treatment. The benchmark will be that at least 70% of participants will have scores over and above the midpoint in both the PBP and PHE groups.
Feasibility of data collection
时间窗: Through the study completion, approximately 1 year depend on gestational at enrollment
E.g.: The investigators will assess the feasibility of quantitative measures with the benchmark of no questionnaires fully missing in \>25% of participants
Adapted Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure
时间窗: 6 weeks
Assesses acceptability, appropriateness, and feasibility of the intervention and Facilitators and Barriers to Participating. Acceptability, appropriateness, and feasibility subscales each consist of 4 items ranging from 1-5. Scores can be calculated by averaging the 4 items and range from 1-5. Higher scores indicate greater acceptability, appropriateness, and feasibility. The benchmark will be that at least 70% of participants will have scores over and above the midpoint for these subscales in both the PBP and PHE groups. Facilitators and Barriers to participating are open-ended questions and will be assessed with qualitative analyses.
Facilitator Adherence to Sessions
时间窗: Through the study completion, approximately 1 year depend on gestational at enrollment
The investigators will assess the percentage of sessions with ≥75% adherence. The benchmark will be ≥70% of sessions will have ≥75% adherence (checklist and audio recordings); 20% of sessions rated.
Participant Adherence to Homework
时间窗: 6 weeks
The investigators will assess the percentage of participants that complete (i.e., upload/submit) ≥75% of the homework assignments. The benchmark will be ≥70% of participants will complete ≥75% of the homework assignments.
次要结局
- The Satisfaction and Dissatisfaction with Body Parts Scale(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Facilitator Feedback(Through the intervention program completion, approximately 1 year)
- Thin Ideal Internalization Scale(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Dutch Restrained Eating Scale(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Body Image in Pregnancy Scale (BIPS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Eating Disorder Examination Questionnaire (EDEQ)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Prenatal Eating Behaviors Screening (PEBS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Intuitive Eating Scale-3 (IES-3)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Eating Disorder Diagnostic Scale (EDDS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Edinburgh Postnatal Depression Scale (EPDS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Generalized Anxiety Disorder Assessment (GAD-7)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Multidimensional Scale of Perceived Social Support (MSPSS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Participant Feedback(6 weeks)
- Thin Ideal Internalization Scale(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- The Satisfaction and Dissatisfaction with Body Parts Scale(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Prenatal Eating Behaviors Screening (PEBS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Eating Disorder Diagnostic Scale (EDDS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Edinburgh Postnatal Depression Scale (EPDS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Dutch Restrained Eating Scale(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Intuitive Eating Scale-3 (IES-3)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Body Image in Pregnancy Scale (BIPS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Eating Disorder Examination Questionnaire (EDEQ)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Generalized Anxiety Disorder Assessment (GAD-7)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Multidimensional Scale of Perceived Social Support (MSPSS)(0 weeks, 6 weeks, 3 months pp, 6 months pp)
- Participant Feedback(6 weeks)
- Neonatal Outcomes(3 months pp)
- Facilitator Feedback(Through the intervention program completion, approximately 1 year)
研究者
Rachel Vanderkruik
Associate Director of Research and Cognitive Behavioral Services
Massachusetts General Hospital