An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Part of paid clinical trials in San Diego, California.
- Sponsor
- San Diego State University
- Study ID
- NCT07792837
- Status
- Recruiting
Conditions
- Anxiety
- Body Awareness
- Diet Quality
- Excessive Gestational Weight Gain
- INTUITIVE EATING
- Perceived Stress
- Physical Activity
- Pregnancy
- Prenatal Depression
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Intuitive Eating Intervention — OTHERThe (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
Study Details
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.
Key Dates
- First listed
- Aug 28, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Intuitive Eating Intervention GroupThe (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.
- No Intervention: Usual Care Group (Waitlist Control)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.
Primary Outcome Measure
Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks [ Time Frame: 8 weeks ]
Central Contacts
- Jeni Green, PhD619-594-6489
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Diego State University | San Diego | California | 92182 | Jeni Green, PhD (PRINCIPAL_INVESTIGATOR) |
| UC San Diego Health | San Diego | California | 92182 |
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