Eating DisordersNCT06659354
Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals
A study testing Pregnant Body Project (PBP) and Pregnancy Health Education (PHE) in people with Eating Disorders and Body Dissatisfaction, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Disorders, Body Dissatisfaction
- What is being tested?
- Pregnant Body Project (PBP) and Pregnancy Health Education (PHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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).
- Conditions
- Eating Disorders, Body Dissatisfaction
- Being tested
- Pregnant Body Project (PBP), Pregnancy Health Education (PHE)
- Keywords
- Eating Disorder, Body Dissatisfaction, Body Image, Pregnancy
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant Body Project (PBP)Behavioural
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.
Pregnancy Health Education (PHE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Body Project (PBP) | Experimental | 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. Receives: Behavioral: Pregnant Body Project (PBP) |
| Pregnancy Health Education (PHE) | Placebo comparator | 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. Receives: Behavioral: Pregnancy Health Education (PHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
The investigators will consider the program feasible if the investigators meet recruitment targets (N=60).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months pp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start6 Jun 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Vanderkruik, Massachusetts General Hospital
- Investigators
- Rachel Vanderkruik, PhD, MSc, Principal investigator, The Center for Women's Mental Health at Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659354
- Sponsor's protocol ID
- 2023P000630
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40752822
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Health and Resilience for Individuals With a Vulnerable Eating History (THRIVE)
- ClinicalTrials.gov ID
- NCT06659354
- Acronym / sponsor ID
- 2023P000630
- Conditions
- Eating Disorders, Body Dissatisfaction
- Keywords
- Eating Disorder, Body Dissatisfaction, Body Image, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Body Project (PBP) | Experimental | 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. |
| Pregnancy Health Education (PHE) | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pregnant Body Project (PBP) |
| 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. | Behavioural | Pregnancy Health Education (PHE) |
Primary outcome
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.
14 secondary outcomes
Thin Ideal Internalization Scale
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Dutch Restrained Eating Scale
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
The Satisfaction and Dissatisfaction with Body Parts Scale
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Body Image in Pregnancy Scale (BIPS)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Eating Disorder Examination Questionnaire (EDEQ)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Prenatal Eating Behaviors Screening (PEBS)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Intuitive Eating Scale-3 (IES-3)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Eating Disorder Diagnostic Scale (EDDS)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 0 weeks, 6 weeks, 3 months pp, 6 months pp
Participant Feedback
Time frame: 6 weeks
Facilitator Feedback
Time frame: Through the intervention program completion, approximately 1 year
Neonatal Outcomes
Time frame: 3 months pp
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 40752822Vanderkruik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Vanderkruik, PhD, MSc principal investigator
The Center for Women's Mental Health at Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnant Body Project (PBP) and Pregnancy Health Education (PHE) in people with Eating Disorders and Body Dissatisfaction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 0 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06659354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.