Excessive Gestational Weight GainNCT07792837
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
A study testing Intuitive Eating Intervention in people with Excessive Gestational Weight Gain and Pregnancy, run by San Diego State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Excessive Gestational Weight Gain, Pregnancy, INTUITIVE EATING
- What is being tested?
- Intuitive Eating Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
San Diego State University
San Diego, California, 92182
Jeni Green, PhD, 619-594-6489, jgreen5@sdsu.edu
Jeni Green, PhD
- Recruiting
UC San Diego Health
San Diego, California, 92182
Jeni Green, PhD, 619-594-6489, jgreen5@sdsu.edu
About this study
Official title: 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?
Read more
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.
Read the detailed description
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.
- Conditions
- Excessive Gestational Weight Gain, Pregnancy, INTUITIVE EATING, Perceived Stress, Prenatal Depression, Anxiety
- Being tested
- Intuitive Eating Intervention
- Keywords
- Excessive Gestational Weight Gain, Obesity, Intuitive Eating, Pregnancy, Body Image, Body Appreciation, Gestational Weight Gain, Maternal Health
- Medical subject headings
- Anxiety Disorders, Motor Activity, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intuitive Eating InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intuitive Eating Intervention Group | Experimental | 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. Receives: Other: Intuitive Eating Intervention |
| Usual Care Group (Waitlist Control) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 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.
Measured: 8 weeks
Burden of the Intervention at 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.
Measured: 8 Weeks
Participant Retention Through the 8-Week Intervention
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).
Measured: Baseline through 8 weeks
Participant Adherence to the Intervention During the 8-Week Intervention
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.
Measured: Baseline through 8 weeks
Participant Engagement with the Intervention During the 8-Week Intervention
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.
Measured: Baseline through 8 weeks
Secondary outcomes (7)
Change from Baseline in Intuitive Eating Scale-3 (IES-3) Score at 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.
Measured: Baseline and 8 weeks
Change from Baseline Health Eating Index (HEI) Score at 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.
Measured: Baseline and 8 weeks
Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines
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.
Measured: From baseline through delivery
Change from Baseline in Perceived Stress Scale (PSS) Score at 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.
Measured: Baseline and 8 weeks
Change from Baseline in Edinburgh Postnatal Depression Scale, United States Version (EPDS-US) Score at 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.
Measured: Baseline and 8 weeks
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 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.
Measured: Baseline and 8 weeks
Change from Baseline in Body Appreciation Scale-2 (BAS-2) Score at 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Excessive Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Jennifer Green, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792837
- Sponsor's protocol ID
- IRB-25-0479
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Meyer M, Carter J, Woodworth E, Miller B, Vanderkruik R, Lopez N, Papini N. Postpartum Body Image and Eating Behaviors: Receptivity to Nondiet Approaches in a Qualitative Study of Perinatal Women. J Nutr Educ Behav. 2026 Jul 17:S1499-4046(26)00149-1. doi: 10.1016/j.jneb.2026.05.018. Online ahead of print.
PubMed 42467026Mehta UJ, Siega-Riz AM, Herring AH. Effect of body image on pregnancy weight gain. Matern Child Health J. 2011 Apr;15(3):324-32. doi: 10.1007/s10995-010-0578-7.
PubMed 20204481Samura T, Steer J, Michelis LD, Carroll L, Holland E, Perkins R. Factors Associated With Excessive Gestational Weight Gain: Review of Current Literature. Glob Adv Health Med. 2016 Jan;5(1):87-93. doi: 10.7453/gahmj.2015.094. Epub 2016 Jan 1.
PubMed 26937318Blau LE, Hormes JM. Preventing Excess Gestational Weight Gain and Obesity in Pregnancy: the Potential of Targeting Psychological Mechanisms. Curr Obes Rep. 2020 Dec;9(4):522-529. doi: 10.1007/s13679-020-00415-9. Epub 2020 Nov 4.
PubMed 33145706Green J, Larkey L, Leiferman JA, Buman M, Oh C, Huberty J. Prenatal yoga and excessive gestational weight gain: A review of evidence and potential mechanisms. Complement Ther Clin Pract. 2022 Feb;46:101551. doi: 10.1016/j.ctcp.2022.101551. Epub 2022 Feb 9.
PubMed 35152057Rezende F, Oliveira BMPM, Poinhos R. Assessment of Intuitive Eating and Mindful Eating among Higher Education Students: A Systematic Review. Healthcare (Basel). 2024 Feb 29;12(5):572. doi: 10.3390/healthcare12050572.
PubMed 38470683