Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals

Targeting Health and Resilience for Individuals With a Vulnerable Eating History (THRIVE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Disorders; Body Dissatisfaction
• Intervention / Treatment: Behavioral: Pregnant Body Project (PBP); Behavioral: Pregnancy Health Education (PHE)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	The investigators will consider the program feasible if the investigators meet recruitment targets (N=60).	0 weeks
Session attendance	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.	6 weeks
Drop Out	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.	6 weeks
Client satisfaction questionnaire (CSQ-8)	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.	6 weeks
Credibility and Expectancy Questionnaire (CEQ)	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.	0 weeks
Feasibility of data collection	E.g.: The investigators will assess the feasibility of quantitative measures with the benchmark of no questionnaires fully missing in >25% of participants	Through the study completion, approximately 1 year depend on gestational at enrollment
Adapted Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure	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.	6 weeks
Facilitator Adherence to Sessions	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.	Through the study completion, approximately 1 year depend on gestational at enrollment
Participant Adherence to Homework	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thin Ideal Internalization Scale	Measures the degree to which a person identifies with the notion that thinness is equivalent to attractiveness, with items ranging from 1-5. Scores are calculated by averaging the 8 items, and range from 1-5, with higher scores indicating greater internalization of the thin ideal.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Dutch Restrained Eating Scale	Measures the frequency of dieting behaviors, with items ranging from 1-5. Scores are calculated by averaging the 10 items, and range from 1-5, with higher scores indicating increased levels of restrictive eating.	0 weeks, 6 weeks, 3 months pp, 6 months pp
The Satisfaction and Dissatisfaction with Body Parts Scale	Measures body dissatisfaction, with items ranging from 1-5. Scores are calculated by averaging the 9 items, and range from 1-5, with higher scores indicating greater body dissatisfaction.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Body Image in Pregnancy Scale (BIPS)	36 items that measure body image during pregnancy, with items ranging from 1-5. The measure is made up of seven subscales: 'preoccupation with physical appearance' (six items), 'dissatisfaction with facial features' (four items), 'sexual attractiveness' (six items), 'prioritizing appearance over body functioning' (five items), 'appearance-related behavioral avoidance' (three items), and 'dissatisfaction with body parts' (six items). Subscale scores are calculated by averaging items, and range from 1-5, with higher scores indicating greater body image disturbance. The investigators adapted wording to administer the questionnaire again during postpartum.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Eating Disorder Examination Questionnaire (EDEQ)	28-item questionnaire measuring ED psychopathology, with items ranging from 0-6. A global score is obtained by averaging all items except for 13-18, with higher scores indicating increased ED symptoms. The clinical cut-off score is 2.8, which indicates a probable ED. Items 13-18 assess frequency of ED behaviors and are not included in the global score.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Prenatal Eating Behaviors Screening (PEBS)	Measures ED psychopathology during pregnancy, with items ranging from 1-5. Scores are calculated by summing the 12 items, and range from 12-60, with higher scores indicating greater ED symptomatology during pregnancy. Scores >39 indicate a current ED.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Intuitive Eating Scale-3 (IES-3)	Measures intuitive eating, with items ranging from 1-5. A global score can be calculated by averaging the 12 items, and range from 1-5, with higher scores indicating greater levels of intuitive eating. Subscales (Unconditional Permission to Eat, Eating for Physical Reasons, Reliance on Hunger and Satiety Cues, and Body-Food Choice Congruence) can be calculated by averaging items specific to each subscale.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Eating Disorder Diagnostic Scale (EDDS)	Provides tentative diagnoses of full threshold anorexia nervosa, full threshold bulimia nervosa, full threshold binge eating disorder, subthreshold anorexia nervosa, subthreshold bulimia nervosa, and subthreshold binge eating disorder. The EDDS also generates an overall ED symptom score based on the sum of all relevant items. Higher scores indicate increased disorder eating symptomology with a clinical cut-off score of 16.5 for the overall symptom composite score (Krabbenborg et al., 2011). Krabbenborg, M. A., Danner, U. N., Larsen, J. K., van der Veer, N., van Elburg, A. A., de Ridder, D. T., Evers, C., Stice, E., & Engels, R. C. (2012). The Eating Disorder Diagnostic Scale: psychometric features within a clinical population and a cut-off point to differentiate clinical patients from healthy controls. European eating disorders review : the journal of the Eating Disorders Association, 20(4), 315-320. https://doi.org/10.1002/erv.1144	0 weeks, 6 weeks, 3 months pp, 6 months pp
Edinburgh Postnatal Depression Scale (EPDS)	Measures depression in pregnancy and postpartum, with items ranging from 0-3. Scores are calculated by summing the 10 items, and range from 0-30, with higher scores indicating greater depressive symptoms.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Generalized Anxiety Disorder Assessment (GAD-7)	Measures anxiety, with items ranging from 0-3. Scores are calculated by summing the 7 items, and range from 0-21, with higher scores indicating greater anxiety.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Multidimensional Scale of Perceived Social Support (MSPSS)	Measures perceived social support, with items ranging from 1-7. A global score is calculated by summing the 12 items, and ranges from 12-84, with higher scores indicating greater perceived social support. Subscales (Significant Other, Family, and Friends) can be calculated by averaging items specific to each subscale.	0 weeks, 6 weeks, 3 months pp, 6 months pp
Participant Feedback	The investigators will conduct exit interviews with participants assigned to the PBP group. The investigators will use this to make further adaptations to the intervention. This is a qualitative assessment informed by the Consolidated Framework Implementation Research.	6 weeks
Facilitator Feedback	The investigators will conduct exit interviews with the PBP group facilitators. The investigators will use this to make further adaptations to the intervention. This is not a scale. It is a survey including open test qualitative questions.	Through the intervention program completion, approximately 1 year
Neonatal Outcomes	Patient reported measures of infant health at birth (e.g., preterm birth, low birthweight), maternal and delivery complications (e.g., preeclampsia), provider interactions, pregnancy and postpartum experiences, and feeding experiences with their baby. Exploratory analyses and descriptive statistics will be conducted for these neonatal outcomes and pregnancy, postpartum and feeding experiences.	3 months pp

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Rachel Vanderkruik, PhD, MSc, The Center for Women's Mental Health at Massachusetts General Hospital

Publications and helpful links

General Publications

• Vanderkruik R, Frisch CM, Woodworth EC, Scharner S, Bartels SJ, Freeman MP, Cohen LS, Stice E. The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals. Contemp Clin Trials. 2025 Sep;156:108039. doi: 10.1016/j.cct.2025.108039. Epub 2025 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Eating Disorder; Body Image; Body Dissatisfaction
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding and Eating Disorders
• Other Study ID Numbers: 2023P000630

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No