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

NCT04623008 | Completed Results

• 1 other identifier: 2019H0441
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Obesity; Weight Gain, Maternal

Keywords

pregnant women; intervention

Outcome Measures

Primary Outcomes (3)

• Percent Change in Body Weight

  Data extracted from electronic medical record

  Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)

• Percent Change in Body Weight

  Data extracted from electronic medical record

  24-27 week-gestation (T2) to 35-37 week-gestation (T3)

• Percent Change in Body Weight

  Data extracted from electronic medical record

  Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)

Secondary Outcomes (37)

• Percentage of Participants Diagnosed With Gestational Diabetes

  24-27 week-gestation (T2) to 35-37 week-gestation (T3)

• Percentage of Participants Diagnosed With Gestational Hypertension

  24-27 week-gestation (T2) to 35-37 week-gestation (T3)

• Percentage of Participants With Cesarean Delivery

  35-37 week-gestation (T3)

• Newborn Body Weight

  35-37 week-gestation (T3)

• Percentage of Participants With Premature (<37 Weeks Gestation) Births

  35-37 week-gestation (T3)

Study Arms (2)

Goal-Oriented Episodic Future Thinking (GOEFT) Intervention

EXPERIMENTAL

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.

Behavioral: Goal-Oriented Episodic Future Thinking

Usual Prenatal Care

NO INTERVENTION

The usual prenatal care group will receive usual care from their providers

Interventions

Goal-Oriented Episodic Future Thinking BEHAVIORAL

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.

Goal-Oriented Episodic Future Thinking (GOEFT) Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants need to be pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Obesity; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Results Point of Contact

• Title: Mei-Wei Chang, PhD
• Organization: Ohio State University College of Nursing

chang.1572@osu.edu

614-247-7211

Study Officials

• Mei-Wei Chang, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoicate Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 10, 2020
• Study Start: February 1, 2021
• Primary Completion: January 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)