NCT04623008

Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Moms Are Worth It is a lifestyle behavior intervention study aims to prevent excessive gestational weight gain in overweight or obese pregnant women through promotion of the stress management, healthy eating, and physical activity. Eligible women will be randomly assigned to a usual care or an intervention plus usual care group. The intervention will last 20 weeks and will be delivered via weekly web and individual health coaching session (10 of them)

Detailed description

Current effective lifestyle behavior intervention studies aimed to prevent excessive gestational weight gain (EGWG) in overweight or obese pregnant women have limited practicality, scalability, and sustainability because of high participant burden and excessive cost for clinical practice. Also, prior studies paid little or no attention to motivation, emotion and cognition, all of which are critical to motivate and enable individuals to engage in healthy lifestyle behaviors and achieve positive health outcomes. A promising approach to prevent EGWG in overweight or obese pregnant women is through goal-oriented episodic future thinking (GOEFT). This pilot randomized controlled trial, aims to prevent EGWG in overweight or obese pregnant women. The proposed self-directed, web-based GOEFT intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (executive function, ExF), thus promoting healthy lifestyle behaviors. This will lead to prevention of EGWG and a reduced rate of gestational diabetes, gestational hypertension, cesarean delivery and fetal macrosomia. Our intervention will last 20 weeks (starting at 17 week-gestation). Participants (N = 90; 50% White, 50% minority) will be recruited and enrolled from prenatal care clinics at The Ohio State University Wexner Medical Center and be randomly assigned to our GOEFT intervention (n = 45) or usual care (n = 45). All participants will be assessed at baseline (\<17 week-gestation, T1), 24-27 week-gestation (T2) and 35-37 week-gestation (T3). Specific aims are (1) to determine feasibility of the GOEFT intervention: recruitment, randomization, retention and intervention implementation, (2) to investigate the potential efficacy of the intervention on gestational weight gain and maternal and birth outcomes, (3) to investigate the potential impact of the intervention on lifestyle behaviors and (4) to investigate the potential impact of the intervention on motivation, emotion and cognition.

Conditions

• Obesity
• Weight Gain, Maternal

Interventions

Type	Name	Description
BEHAVIORAL	Goal-Oriented Episodic Future Thinking	Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-01-30
• Completion: 2023-12-30
• First posted: 2020-11-10
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

1 site across 1 country: United States