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Feasibility and Preliminary Effects of an Online Intuitive Eating Intervention on Gestational Weight Gain and Well-Being in Pregnant Women

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
San Diego State University
RECRUITING
San Diego
UC San Diego Health
RECRUITING
San Diego
Contact Information
Primary
Jeni Green, PhD
jgreen5@sdsu.edu
619-594-6489
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
Experimental: Intuitive Eating Intervention Group
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego
Leads: San Diego State University

This content was sourced from clinicaltrials.gov

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