An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jeni Green, PhD
- Número de teléfono: 619-594-6489
- Correo electrónico: jgreen5@sdsu.edu
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92182
- Reclutamiento
- San Diego State University
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Contacto:
- Jeni Green, PhD
- Número de teléfono: 619-594-6489
- Correo electrónico: jgreen5@sdsu.edu
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Investigador principal:
- Jeni Green, PhD
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San Diego, California, Estados Unidos, 92182
- Reclutamiento
- UC San Diego Health
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Contacto:
- Jeni Green, PhD
- Número de teléfono: 619-594-6489
- Correo electrónico: jgreen5@sdsu.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
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 |
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Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks
Periodo de tiempo: 8 weeks
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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.
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8 weeks
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Burden of the Intervention at 8 Weeks
Periodo de tiempo: 8 Weeks
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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.
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8 Weeks
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Participant Retention Through the 8-Week Intervention
Periodo de tiempo: Baseline through 8 weeks
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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).
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Baseline through 8 weeks
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Participant Adherence to the Intervention During the 8-Week Intervention
Periodo de tiempo: Baseline through 8 weeks
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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.
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Baseline through 8 weeks
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Participant Engagement with the Intervention During the 8-Week Intervention
Periodo de tiempo: Baseline through 8 weeks
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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.
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Baseline through 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Intuitive Eating Scale-3 (IES-3) Score at 8 Weeks
Periodo de tiempo: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Change from Baseline Health Eating Index (HEI) Score at 8-weeks
Periodo de tiempo: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines
Periodo de tiempo: From baseline through delivery
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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.
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From baseline through delivery
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Change from Baseline in Perceived Stress Scale (PSS) Score at 8 Weeks
Periodo de tiempo: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Change from Baseline in Edinburgh Postnatal Depression Scale, United States Version (EPDS-US) Score at 8 Weeks
Periodo de tiempo: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 8 Weeks
Periodo de tiempo: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Change from Baseline in Body Appreciation Scale-2 (BAS-2) Score at 8 Weeks
Periodo de tiempo: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Blau 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.
- 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.
- Mehta 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.
- Samura 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.
- Green 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.
- Rezende 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Cambios en el peso corporal
- Exceso de peso
- Aumento de peso
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Aumento de peso gestacional
- Obesidad
- Desórdenes de ansiedad
- Actividad del motor
Otros números de identificación del estudio
- IRB-25-0479
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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