Targeting Health and Resilience for Individuals With a Vulnerable Eating History (THRIVE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility of recruitment
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Pregnant Body Project (PBP)
The Body Project is typically delivered as four 1-hour weekly sessions consisting of written, verbal, and behavioral exercises. The sessions aim to induce cognitive dissonance by encouraging participants to challenge the thin-ideal, a theoretically and empirically supported component of ED prevention. This adapted version of the Body Project (the Pregnant Body Project; PBP) consists of 6 1-hour, weekly group sessions delivered via Zoom. Since the target population consists of individuals with histories of an ED or disordered eating behaviors, PBP also includes elements from a treatment intervention (i.e., the Body Project Treatment 8.0 manual). PBP was adapted iteratively with a needs assessment, expert stakeholder input, and participant feedback following a mock trial with individuals with lived experience (i.e., individuals with histories of an ED who have given birth). This condition will be peer-delivered by facilitators with lived experience.
Intervention: Pregnant Body Project (PBP) (Behavioral)
Pregnancy Health Education (PHE)
This time- dose- and attention- matched control condition accounts for the potential effects of time spent and support from group members and facilitators. Participants assigned to the PHE group will also be asked to attend 6, 1-hour, weekly group sessions via Zoom. During the sessions participants receive psychoeducation on body image and disordered eating during pregnancy but will not engage in any dissonance-inducing exercises. Participants will also receive lifestyle education specific to pregnancy (e.g., proper nutrition, sleep, physical activity), tied back to body image and disordered eating.
Intervention: Pregnancy Health Education (PHE) (Behavioral)
Outcomes
Primary Outcomes
Feasibility of recruitment
Time Frame: 0 weeks
The investigators will consider the program feasible if the investigators meet recruitment targets (N=60).
Session attendance
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Rachel Vanderkruik
Associate Director of Research and Cognitive Behavioral Services
Massachusetts General Hospital