NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingNA

Sponsor: San Diego State University

Conditions: Excessive Gestational Weight Gain, Pregnancy, INTUITIVE EATING, Perceived Stress, Prenatal Depression

Interventions: Intuitive Eating Intervention

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

San Diego, California, United States
San Diego, California, United States