Clinical trial NCT04623008: Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Official title: Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Gain, Maternal
Keywords: pregnant women
intervention
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Body Weight
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percent Change in Body Weight
timeFrame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
measure: Percent Change in Body Weight
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary outcomes:
measure: Percentage of Participants Diagnosed With Gestational Diabetes
timeFrame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
measure: Percentage of Participants Diagnosed With Gestational Hypertension
timeFrame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
measure: Percentage of Participants With Cesarean Delivery
timeFrame: 35-37 week-gestation (T3)
measure: Newborn Body Weight
timeFrame: 35-37 week-gestation (T3)
measure: Percentage of Participants With Premature (<37 Weeks Gestation) Births
timeFrame: 35-37 week-gestation (T3)
measure: Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percentage of Change in Dietary Intake Behaviors - Fat (gm)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Autonomous Motivation for Physical Activity
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Autonomous Motivation for Physical Activity
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Autonomous Motivation for Stress Management
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Autonomous Motivation for Stress Management
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Autonomous Motivation for Healthy Eating
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Autonomous Motivation for Healthy Eating
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Healthy Eating Self-efficacy
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Healthy Eating Self-efficacy
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Coping Self-efficacy
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Coping Self-efficacy
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Physical Activity Self-efficacy
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Physical Activity Self-efficacy
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Emotion Regulation
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Emotion Regulation
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Perceived Stress
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Perceived Stress
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Executive Function - Behavior Regulation
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Executive Function - Behavioral Regulation
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
measure: Change in Executive Function - Metacognition
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
measure: Change in Executive Function - Metacognition
timeFrame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Mei-Wei Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: