Clinical trial NCT06659354: Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals
Official title: Targeting Health and Resilience for Individuals with a Vulnerable Eating History (THRIVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Body Dissatisfaction
Keywords: Eating Disorder
Body Dissatisfaction
Body Image
Pregnancy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

1. Within the first or second trimester of pregnancy at enrollment
2. 18 years or older
3. Able to provide informed consent
4. Endorse a self-reported history of an eating disorder or disordered eating behaviors
5. Are willing and able to comply with all group and study procedures
6. English fluency and literacy

Exclusion Criteria:

1. 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
2. Do not have access to a device with a camera

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 0 weeks
measure: Session attendance
timeFrame: 6 weeks
measure: Drop Out
timeFrame: 6 weeks
measure: Client satisfaction questionnaire (CSQ-8)
timeFrame: 6 weeks
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: 0 weeks
measure: Feasibility of data collection
timeFrame: Through the study completion, approximately 1 year depend on gestational at enrollment
measure: Adapted Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure
timeFrame: 6 weeks
measure: Facilitator Adherence to Sessions
timeFrame: Through the study completion, approximately 1 year depend on gestational at enrollment
measure: Participant Adherence to Homework
timeFrame: 6 weeks
Secondary outcomes:
measure: Thin Ideal Internalization Scale
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Dutch Restrained Eating Scale
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: The Satisfaction and Dissatisfaction with Body Parts Scale
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Body Image in Pregnancy Scale (BIPS)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Eating Disorder Examination Questionnaire (EDEQ)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Prenatal Eating Behaviors Screening (PEBS)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Intuitive Eating Scale-3 (IES-3)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Eating Disorder Diagnostic Scale (EDDS)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
measure: Participant Feedback
timeFrame: 6 weeks
measure: Facilitator Feedback
timeFrame: Through the intervention program completion, approximately 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: The Center for Women's Mental Health at Massachusetts General Hospital
name: Rachel Vanderkruik, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: