Feasibility and Preliminary Effects of an Online Intuitive Eating Intervention on Gestational Weight Gain and Well-Being in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intuitive Eating Intervention (Other)
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.
结局指标
主要结局
Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from Baseline in Intuitive Eating Scale-3 (IES-3) Score at 8 Weeks(Baseline and 8 weeks)
- Change from Baseline Health Eating Index (HEI) Score at 8-weeks(Baseline and 8 weeks)
- Proportion of Participants Exceeding Recommended Gestational Weight Gain Guidelines(From baseline through delivery)
- Change from Baseline in Perceived Stress Scale (PSS) Score at 8 Weeks(Baseline and 8 weeks)
- Change from Baseline in Edinburgh Postnatal Depression Scale, United States Version (EPDS-US) Score at 8 Weeks(Baseline and 8 weeks)
- Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 8 Weeks(Baseline and 8 weeks)
- Change from Baseline in Body Appreciation Scale-2 (BAS-2) Score at 8 Weeks(Baseline and 8 weeks)
研究者
Jennifer Green
Assistant Professor
San Diego State University