An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being

NCT07792837 | Recruiting

• 1 other identifier: IRB-25-0479
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this feasibility randomized controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity. The main questions we aim to answer are: RQ1: What is the feasibility (acceptability and demand) of implementing an Intuitive Eating Intervention among pregnant and postpartum women? RQ2: How does participation in the Pregnancy Intuitive Eating Intervention (PIE-I) impact key maternal health outcomes (i.e., gestational weight gain, intuitive eating behaviors, dietary quality, body image, and mental health) compared to a wait-list control? Researchers will compare the Pregnancy Intuitive Eating Intervention (PIE-I) intervention group with the wait-list control to see what impact the PIE-I has on maternal well-being. Participants randomized to the intervention group will complete the 8 week asynchronous IE intervention and have an opportunity to interview at the end of the study.

Conditions

Excessive Gestational Weight Gain; Pregnancy; INTUITIVE EATING; Perceived Stress; Prenatal Depression; Anxiety; Diet Quality; Physical Activity; Body Awareness

Keywords

Excessive Gestational Weight Gain; Obesity; Intuitive Eating; Pregnancy; Body Image; Body Appreciation; Gestational Weight Gain; Maternal Health

Outcome Measures

Primary Outcomes (5)

• Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks

  Intervention acceptability will be assessed using a post-intervention satisfaction survey administered at 8 weeks. Participants will rate satisfaction with the intervention, intention to continue using intuitive eating principles, and perceived appropriateness of the intervention content for pregnancy on a 1-5 scale. The feasibility benchmark will be met if ≥70% of participants provide a rating of ≥4 for each indicator.

  8 weeks

• Burden of the Intervention at 8 Weeks

  Perceived intervention burden will be assessed using a post-intervention survey on a 1-5 scale, with higher scores indicating greater perceived burden. The feasibility benchmark will be a mean burden rating of ≤2.5.

  8 Weeks

• Participant Retention Through the 8-Week Intervention

  Retention will be calculated as the proportion of enrolled participants who complete the intervention and 8-week post-intervention assessment. The feasibility benchmark is ≥80% retention (≥64 of 80 enrolled participants).

  Baseline through 8 weeks

• Participant Adherence to the Intervention During the 8-Week Intervention

  Intervention adherence will be assessed using Moodle analytics. Participants will be considered adherent if they complete at least 6 of the 8 intervention modules. The feasibility benchmark will be met if ≥70% of participants meet this adherence criterion.

  Baseline through 8 weeks

• Participant Engagement with the Intervention During the 8-Week Intervention

  Participant engagement will be assessed using Moodle and Zoom analytics. Platform interactions will include logins, module views, and attendance at weekly Zoom office hours. The feasibility benchmark will be a median of ≥1 platform interaction per participant per week during the 8-week intervention.

  Baseline through 8 weeks

Secondary Outcomes (7)

• Change from Baseline in Intuitive Eating Scale-3 (IES-3) Score at 8 Weeks

  Baseline and 8 weeks

• Change from Baseline Health Eating Index (HEI) Score at 8-weeks

  Baseline and 8 weeks

• Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines

  From baseline through delivery

• Change from Baseline in Perceived Stress Scale (PSS) Score at 8 Weeks

  Baseline and 8 weeks

• Change from Baseline in Edinburgh Postnatal Depression Scale, United States Version (EPDS-US) Score at 8 Weeks

  Baseline and 8 weeks

Study Arms (2)

Intuitive Eating Intervention Group

EXPERIMENTAL

The (PIE-I) will be based on the IE Book \& Workbook published by RDNs Evelyn Tribole \& Elyse Resch. Each week, participants will be asked to watch 20 minute online modules and complete 1-2 workbook pages (workbook provided for free). Optional weekly office hours will be held by Certified Intuitive Eating Counselors. Participants in the PIE-I will complete two online surveys - one at baseline (upon enrollment) and one after 8 weeks (the same surveys and time schedules as the intervention group). Each completed survey will earn participants an e-gift card as compensation for their time. Participants will also have an opportunity to complete a virtual interview at the end of the 8-week study.

Other: Intuitive Eating Intervention

Usual Care Group (Waitlist Control)

NO INTERVENTION

Participants assigned to the Wait-List Control Group will continue their usual daily habits and routines during the 8-week study period. They will not receive access to the Intuitive Eating modules or workbook materials until the completion of their participation. During the 8-week study period, control participants will complete two online surveys - one at baseline (upon enrollment) and one after 8 weeks (the same surveys and time schedules as the intervention group). Each completed survey will earn participants an e-gift card as compensation for their time. Control participants may contact the study team via the study email at any time with questions or concerns.

Interventions

Intuitive Eating Intervention OTHER

The (PIE-I) will be based on the IE Book \& Workbook published by RDNs Evelyn Tribole \& Elyse Resch. Each week, participants will be asked to watch 20 minute online modules and complete 1-2 workbook pages. Optional office hours will be held by Certified Intuitive Eating Counselors. The online modules are as follows: Week 1: Orientation of IE framework, overview of 10 Intuitive Eating Principles, and Principle 1-Reject Diet Culture Week 2: Principle 2-Honor Your Hunger \& Principle 3-Make Peace with Food Week 3: Principle 4-Discover the Satisfaction Factor Week 4: Principle 5-Feel Your Fullness Week 5: Principle 6-Challenge the Food Police Week 6: Principle 7-Cope with Your Emotions with Kindness Week 7: Principle 8-Respect Your Body\& Principle 9 -Movement: Feel the Difference Week 8: Principle 10-Honor Your Health with Gentle Nutrition, wrap-up and conclusion of modules

Intuitive Eating Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Pregnant women between 12 weeks and \<22 weeks gestation
• Pre-pregnancy BMI 30.0 kg/m² or greater
• Able to read and understand English (for intervention materials and questionnaires)
• Receiving prenatal care at UC San Diego Health (UCSD)
• Reliable access to a device (e.g., smartphone, tablet, or computer) with internet connection

You may not qualify if:

• Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder, ARFID)
• High-risk pregnancy or medical complications that may significantly affect diet, physical activity, or weight gain (e.g., gestational diabetes requiring insulin, preeclampsia, hyperemesis gravidarum)
• Multiple gestation pregnancy (e.g., twins or higher-order multiples)
• Current participation in another nutrition, weight management, or behavioral intervention study
• Severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or current substance use disorder that would interfere with participation
• Inability to provide informed consent or comply with study procedures

Sponsors & Collaborators

• San Diego State University: lead
• University of California, San Diego: collaborator

Study Sites (2)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

UC San Diego Health

San Diego, California, 92182, United States

RECRUITING

Related Publications (6)

• Meyer M, Carter J, Woodworth E, Miller B, Vanderkruik R, Lopez N, Papini N. Postpartum Body Image and Eating Behaviors: Receptivity to Nondiet Approaches in a Qualitative Study of Perinatal Women. J Nutr Educ Behav. 2026 Jul 17:S1499-4046(26)00149-1. doi: 10.1016/j.jneb.2026.05.018. Online ahead of print.

  PMID: 42467026 BACKGROUND

• Mehta UJ, Siega-Riz AM, Herring AH. Effect of body image on pregnancy weight gain. Matern Child Health J. 2011 Apr;15(3):324-32. doi: 10.1007/s10995-010-0578-7.

  PMID: 20204481 BACKGROUND

• Samura T, Steer J, Michelis LD, Carroll L, Holland E, Perkins R. Factors Associated With Excessive Gestational Weight Gain: Review of Current Literature. Glob Adv Health Med. 2016 Jan;5(1):87-93. doi: 10.7453/gahmj.2015.094. Epub 2016 Jan 1.

  PMID: 26937318 BACKGROUND

• Blau LE, Hormes JM. Preventing Excess Gestational Weight Gain and Obesity in Pregnancy: the Potential of Targeting Psychological Mechanisms. Curr Obes Rep. 2020 Dec;9(4):522-529. doi: 10.1007/s13679-020-00415-9. Epub 2020 Nov 4.

  PMID: 33145706 BACKGROUND

• Green J, Larkey L, Leiferman JA, Buman M, Oh C, Huberty J. Prenatal yoga and excessive gestational weight gain: A review of evidence and potential mechanisms. Complement Ther Clin Pract. 2022 Feb;46:101551. doi: 10.1016/j.ctcp.2022.101551. Epub 2022 Feb 9.

  PMID: 35152057 BACKGROUND

• Rezende F, Oliveira BMPM, Poinhos R. Assessment of Intuitive Eating and Mindful Eating among Higher Education Students: A Systematic Review. Healthcare (Basel). 2024 Feb 29;12(5):572. doi: 10.3390/healthcare12050572.

  PMID: 38470683 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Motor Activity; Obesity; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Central Study Contacts

Jeni Green, PhD

CONTACT

619-594-6489; jgreen5@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)