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

The Ohio State University logo

The Ohio State University

Status

Completed

Conditions

Obesity
Weight Gain, Maternal

Treatments

Behavioral: Goal-Oriented Episodic Future Thinking

Study type

Interventional

Funder types

Other

Identifiers

NCT04623008
2019H0441

Details and patient eligibility

About

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)

Full 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.

Enrollment

70 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Participants must be pregnant women ≤ 13 week-gestation with a single fetus as assessed by ultrasound.
  • Participants must also have self-reported pre-pregnancy body mass index (BMI) of 25.0-45.0 kg/m2 and height (height and weight to compute body mass index).
  • Ability to read and speak English,
  • Age of 18-45 years,
  • Access to a working smart phone with unlimited text messaging,
  • Access to internet,
  • Receipt of prenatal care from our collaborating clinics and plan to deliver the baby at The Ohio State University (OSU) Wexner Medical Center,
  • Resident of Franklin Count,
  • Committed to the 20-week intervention.

Exclusion criteria

  • Self-reported history of ≥ 3 miscarriages,
  • Planned termination of the pregnancy,
  • Diagnosed hypertension and/or type 1 or 2 diabetes,
  • History of or current diagnosis of an eating disorder,
  • Serious current physical disease (e.g., renal disease or cancer),
  • Past bariatric surgery,
  • Current or history of substance abuse in the past 6 months,
  • Current treatment for a serious psychological disorder (e.g., schizophrenia and bipolar disorder),
  • Contraindications to walking,
  • Consented women will become not eligible to participate in the study if they are not randomized by 16-week 6 days gestation. This is because the study intervention starts ≤ 17 weeks gestation.
  • Women will become not ineligible for participation if they did not complete the baseline data.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
Experimental group
Description:
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Treatment:
Behavioral: Goal-Oriented Episodic Future Thinking
Usual Prenatal Care
No Intervention group
Description:
The usual prenatal care group will receive usual care from their providers

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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