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NCT Number: NCT07792837

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

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.

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Key information

Conditions

Excessive Gestational Weight Gain Anxiety Anxiety Disorders Behavior Body Awareness Body Weight Body Weight Changes Diet Quality Gestational Weight Gain INTUITIVE EATING Mental Disorders Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Perceived Stress Physical Activity Pregnancy Prenatal Depression Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University, San Diego, California, United States

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About this study

This study is designed as a pilot feasibility trial. We plan to enroll 80 participants (40 per group; 1:1 randomization).

The purpose of this study is to evaluate the feasibility and preliminary effects of an evidence-based Intuitive Eating (IE) intervention, adapted from the Tribole and Resch framework, among pregnant individuals with obesity. Feasibility will be determined based on acceptability and demand scores. Acceptability will be assessed through satisfaction, perceived appropriateness, burden, and intent to continue use. Demand will be defined as retention and adherence to the intervention and participant engagement. Preliminary effects of the IE intervention will be explored in relation to the prevention of excessive gestational weight gain, intuitive eating behaviors, dietary quality, mental health, body image, and perceived stress.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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.

  2. Burden of the Intervention at 8 Weeks

    Time frame: 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.

  3. Participant Retention Through the 8-Week Intervention

    Time frame: Baseline through 8 weeks

    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).

  4. Participant Adherence to the Intervention During the 8-Week Intervention

    Time frame: Baseline through 8 weeks

    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.

  5. Participant Engagement with the Intervention During the 8-Week Intervention

    Time frame: Baseline through 8 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline and 8 weeks

    Intuitive eating will be assessed using the Intuitive Eating Scale-3 (IES-3). The IES-3 assesses individuals' tendency to eat in response to physiological hunger and satiety cues rather than external or emotional cues. Higher scores indicate greater levels of intuitive eating. Change in IES-3 score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.

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

    Time frame: Baseline and 8 weeks

    Diet quality will be assessed using the Healthy Eating Index (HEI), calculated from dietary intake data collected using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. The HEI assesses alignment with the Dietary Guidelines for Americans, with total scores ranging from 0 to 100. Higher scores indicate greater adherence to dietary recommendations and better overall diet quality.

  3. Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines

    Time frame: From baseline through delivery

    Gestational weight gain will be evaluated relative to recommended ranges based on pre-pregnancy body mass index (BMI) using Institute of Medicine (IOM) gestational weight gain guidelines. Excessive gestational weight gain (EGWG) will be defined as total gestational weight gain exceeding the recommended range for the participant's pre-pregnancy BMI category. The proportion of participants with EGWG will be compared between the intervention and wait-list control groups.

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

    Time frame: Baseline and 8 weeks

    Perceived stress will be assessed using the Perceived Stress Scale (PSS-10), which measures the degree to which situations in one's life are perceived as stressful. The PSS-10 produces a total score ranging from 0 to 40. Higher scores indicate greater perceived stress. Change in PSS score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.

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

    Time frame: Baseline and 8 weeks

    Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale, United States version (EPDS-US). The EPDS is a self-report measure designed to assess symptoms of depression during the perinatal period. The 10-item scale produces a total score ranging from 0 to 30, with higher scores indicating greater depressive symptom severity. Change in EPDS-US score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.

  6. Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 8 Weeks

    Time frame: Baseline and 8 weeks

    Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity. Change in GAD-7 score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.

  7. Change from Baseline in Body Appreciation Scale-2 (BAS-2) Score at 8 Weeks

    Time frame: Baseline and 8 weeks

    Body appreciation will be assessed using the Body Appreciation Scale-2 (BAS-2), a 10-item measure assessing acceptance of, favorable opinions toward, and respect for one's body. Items are rated on a 5-point scale, and an overall score is calculated by averaging item responses, resulting in scores ranging from 1-5. Higher scores indicate greater body appreciation. Change in BAS-2 score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeni Green, PhD

CONTACT

[email protected]

619-594-6489

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • University of California, San Diego

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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