RecruitingRecruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
NCT07792837 · San Diego State University
In plain English
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Official title
Feasibility and Preliminary Effects of an Online Intuitive Eating Intervention on Gestational Weight Gain and Well-Being in Pregnant Women
About this 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.
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
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-09
Estimated completion: 2027-12
Last updated: 2026-09-15
Interventions
Other: Intuitive Eating Intervention
Primary outcomes
- • Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks (8 weeks)
- • Burden of the Intervention at 8 Weeks (8 Weeks)
- • Participant Retention Through the 8-Week Intervention (Baseline through 8 weeks)
Sponsor
San Diego State University · other
With: University of California, San Diego
Contacts & investigators
ContactJeni Green, PhD · contact · jgreen5@sdsu.edu · 619-594-6489
All locations (2)
San Diego State UniversityRecruiting
San Diego, California, United States
UC San Diego HealthRecruiting
San Diego, California, United States