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NCT07792837NARecruiting

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

San Diego State University

Start Date

9/1/2026

Completion Date

12/1/2027

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 research questions 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.

Detailed Description

This study is designed as a pilot feasibility trial with a target enrollment of 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Intuitive Eating Intervention

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Conditions

Excessive Gestational Weight GainPregnancyINTUITIVE EATINGPerceived StressPrenatal DepressionAnxietyDiet QualityPhysical ActivityBody Awareness

Locations

San Diego State University

San Diego, California 92182

United States

UC San Diego Health

San Diego, California 92182

United States