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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Publications: details revised at 6 of 6 entries
    • Study description expanded, about 1 word
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07792837
Lead Sponsor San Diego State University
Collaborators: University of California, San Diego
Conditions
(from sponsor)
Excessive Gestational Weight Gain, Pregnancy, INTUITIVE EATING, Perceived Stress, Prenatal Depression, Anxiety, Diet Quality, Physical Activity +1 more
Related terms Anxiety Disorders, Gestational Weight Gain, Motor Activity, Obesity
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov