Anxiety, Body Awareness, Diet Quality, Excessive Gestational Weight Gain, INTUITIVE EATING, Perceived Stress, Physical Activity, Pregnancy, Prenatal Depression
Conditions
Keywords
Excessive Gestational Weight Gain, Obesity, Intuitive Eating, Pregnancy, Body Image, Body Appreciation, Gestational Weight Gain, Maternal Health
Brief 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. 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.
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.
Interventions
OTHERIntuitive 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
Sponsors
San Diego State University
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks | 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. |
| Burden of the Intervention at 8 Weeks | 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. |
| Participant Retention Through the 8-Week Intervention | 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). |
| Participant Adherence to the Intervention During the 8-Week Intervention | 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. |
| Participant Engagement with the Intervention During the 8-Week Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Intuitive Eating Scale-3 (IES-3) Score at 8 Weeks | 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. |
| Change from Baseline Health Eating Index (HEI) Score at 8-weeks | 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. |
| Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines | 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. |
| Change from Baseline in Perceived Stress Scale (PSS) Score at 8 Weeks | 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. |
| Change from Baseline in Edinburgh Postnatal Depression Scale, United States Version (EPDS-US) Score at 8 Weeks | 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. |
| Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 8 Weeks | 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. |
| Change from Baseline in Body Appreciation Scale-2 (BAS-2) Score at 8 Weeks | 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. |
Countries
United States
Contacts
CONTACTJeni Green, PhD
Outcome results
None listed