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

10 september 2026 uppdaterad av: Jennifer Green, San Diego State University

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • San Diego, California, Förenta staterna, 92182
        • Rekrytering
        • San Diego State University
        • Kontakt:
        • Huvudutredare:
          • Jeni Green, PhD
      • San Diego, California, Förenta staterna, 92182
        • Rekrytering
        • UC San Diego Health
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intuitive Eating Intervention Group

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 (workbook provided for free). Optional weekly office hours will be held by Certified Intuitive Eating Counselors.

Participants in the PIE-I will complete two online surveys - one at baseline (upon enrollment) and one after 8 weeks (the same surveys and time schedules as the intervention group). Each completed survey will earn participants an e-gift card as compensation for their time. Participants will also have an opportunity to complete a virtual interview at the end of the 8-week study.
Övrig: Intuitive Eating Intervention

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
Inget ingripande: Usual Care Group (Waitlist Control)

Participants assigned to the Wait-List Control Group will continue their usual daily habits and routines during the 8-week study period. They will not receive access to the Intuitive Eating modules or workbook materials until the completion of their participation.

During the 8-week study period, control participants will complete two online surveys - one at baseline (upon enrollment) and one after 8 weeks (the same surveys and time schedules as the intervention group). Each completed survey will earn participants an e-gift card as compensation for their time.

Control participants may contact the study team via the study email at any time with questions or concerns.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks
Tidsram: 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.
8 weeks
Burden of the Intervention at 8 Weeks
Tidsram: 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.
8 Weeks
Participant Retention Through the 8-Week Intervention
Tidsram: Baseline through 8 weeks
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).
Baseline through 8 weeks
Participant Adherence to the Intervention During the 8-Week Intervention
Tidsram: Baseline through 8 weeks
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.
Baseline through 8 weeks
Participant Engagement with the Intervention During the 8-Week Intervention
Tidsram: Baseline through 8 weeks
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.
Baseline through 8 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline in Intuitive Eating Scale-3 (IES-3) Score at 8 Weeks
Tidsram: Baseline and 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.
Baseline and 8 weeks
Change from Baseline Health Eating Index (HEI) Score at 8-weeks
Tidsram: Baseline and 8 weeks
Diet quality will be assessed using the Healthy Eating Index (HEI), calculated from dietary intake data collected using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. The HEI assesses alignment with the Dietary Guidelines for Americans, with total scores ranging from 0 to 100. Higher scores indicate greater adherence to dietary recommendations and better overall diet quality.
Baseline and 8 weeks
Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines
Tidsram: From baseline through delivery
Gestational weight gain will be evaluated relative to recommended ranges based on pre-pregnancy body mass index (BMI) using Institute of Medicine (IOM) gestational weight gain guidelines. Excessive gestational weight gain (EGWG) will be defined as total gestational weight gain exceeding the recommended range for the participant's pre-pregnancy BMI category. The proportion of participants with EGWG will be compared between the intervention and wait-list control groups.
From baseline through delivery
Change from Baseline in Perceived Stress Scale (PSS) Score at 8 Weeks
Tidsram: Baseline and 8 weeks
Perceived stress will be assessed using the Perceived Stress Scale (PSS-10), which measures the degree to which situations in one's life are perceived as stressful. The PSS-10 produces a total score ranging from 0 to 40. Higher scores indicate greater perceived stress. Change in PSS score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.
Baseline and 8 weeks
Change from Baseline in Edinburgh Postnatal Depression Scale, United States Version (EPDS-US) Score at 8 Weeks
Tidsram: Baseline and 8 weeks
Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale, United States version (EPDS-US). The EPDS is a self-report measure designed to assess symptoms of depression during the perinatal period. The 10-item scale produces a total score ranging from 0 to 30, with higher scores indicating greater depressive symptom severity. Change in EPDS-US score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.
Baseline and 8 weeks
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 8 Weeks
Tidsram: Baseline and 8 weeks
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity. Change in GAD-7 score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.
Baseline and 8 weeks
Change from Baseline in Body Appreciation Scale-2 (BAS-2) Score at 8 Weeks
Tidsram: Baseline and 8 weeks
Body appreciation will be assessed using the Body Appreciation Scale-2 (BAS-2), a 10-item measure assessing acceptance of, favorable opinions toward, and respect for one's body. Items are rated on a 5-point scale, and an overall score is calculated by averaging item responses, resulting in scores ranging from 1-5. Higher scores indicate greater body appreciation. Change in BAS-2 score from baseline to the 8-week post-intervention assessment will be compared between the intervention and wait-list control groups.
Baseline and 8 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

San Diego State University

Samarbetspartners

University of California, San Diego

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 augusti 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

25 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

25 augusti 2026

Första postat (Faktisk)

28 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB-25-0479

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

There is no plan to share individual participant-level data. Study results will be reported and disseminated in aggregate form only, with identifying information removed to protect participant confidentiality.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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