Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

Official Title

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

Details

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.

Keywords

Excessive Gestational Weight Gain, Pregnancy, INTUITIVE EATING, Perceived Stress, Prenatal Depression, Anxiety, Diet Quality, Physical Activity, Body Awareness, Obesity, Body Image, Body Appreciation, Gestational Weight Gain, Maternal Health, Anxiety Disorders, Motor Activity, Intuitive Eating Intervention

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego Health accepting new patients
    San Diego California 92182 United States
  • San Diego State University accepting new patients
    San Diego California 92182 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
San Diego State University
ID
NCT07792837
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated