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

San Diego State University80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Interventions

Intuitive Eating InterventionOTHER

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 Hunger \& Principle 3-Make Peace with Food Week 3: Principle 4-Discover the Satisfaction Factor Week 4: Principle 5-Feel Fullness Week 5: Principle 6-Challenge the Food Police Week 6: Principle 7-Cope with Emotions with Kindness Week 7: Principle 8-Respect Body\& Principle 9 -Movement: Feel the Difference Week 8: Principle 10-Honor Health with Gentle Nutrition, wrap-up and conclusion of modules

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Burden of the Intervention at 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.

Time frame: 8 Weeks

Participant Retention Through the 8-Week Intervention

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).

Time frame: Baseline through 8 weeks

Participant Adherence to the Intervention During the 8-Week Intervention

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.

Time frame: Baseline through 8 weeks

Participant Engagement with the Intervention During the 8-Week Intervention

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.

Time frame: Baseline through 8 weeks

Secondary Outcomes

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