Recruiting

PIE-I

Sponsor:

San Diego State University

Code:

NCT07792837

Conditions

Excessive Gestational Weight Gain

Pregnancy

INTUITIVE EATING

Perceived Stress

Prenatal Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intuitive Eating Intervention

Study Details

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

Study ID

NCT07792837

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Intuitive Eating Intervention

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

Primary outcome measure

  • Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks [ Time Frame: 8 weeks ]
  • Burden of the Intervention at 8 Weeks [ Time Frame: 8 Weeks ]
  • Participant Retention Through the 8-Week Intervention [ Time Frame: Baseline through 8 weeks ]
  • Participant Adherence to the Intervention During the 8-Week Intervention [ Time Frame: Baseline through 8 weeks ]
  • Participant Engagement with the Intervention During the 8-Week Intervention [ Time Frame: Baseline through 8 weeks ]

Central Contacts and Locations

Central contacts

Jeni Green, PhD

619-594-6489jgreen5@sdsu.edu

Locations

San Diego State University

Recruiting

San Diego, California, United States, 92182

Contacts

Jeni Green, PhD

619-594-6489jgreen5@sdsu.edu

Principal Investigator:

Jeni Green, PhD

UC San Diego Health

Recruiting

San Diego, California, United States, 92182

Contacts

Jeni Green, PhD

619-594-6489jgreen5@sdsu.edu

More Information

Sponsor

San Diego State University

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by San Diego State University on 2026-08-28.