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

Obesity Clinical Trial

— MAWI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04623008
• Other study ID #: 2019H0441
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Obesity
• Overweight
• Weight Gain
• Weight Gain, Maternal

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change in Body weight	Data extracted from electronic medical record	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Primary	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	Change in Gestational Diabetes status	Data extracted from electronic medical record	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Gestational Hypertension status	Data extracted from electronic medical record	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Mode of Delivery	Data extracted from electronic medical record	35-37 week-gestation (T3)
Secondary	Newborn body weight	Data extracted from electronic medical record.	35-37 week-gestation (T3)
Secondary	Gestational age at birth	Data extracted from electronic medical record.; The higher value, the higher gestational age	35-37 week-gestation (T3)
Secondary	Change in Dietary Intake Behaviors	Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants will complete 24-hour Recalls on two random days over a week. The variables of interest include calories, fat, sugary drinks, fruit and vegetable intakes. The higher scores indicate higher caloric, fat, sugary drinks, fruit and vegetable intakes.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Dietary Intake Behaviors	Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants will complete 24-hour Recalls on two random days over a week. The variables of interest include calories, fat, sugary drinks, fruit and vegetable intakes. The higher scores indicate higher caloric, fat, sugary drinks, fruit and vegetable intakes.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Dietary Intake Behaviors	Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants will complete 24-hour Recalls on two random days over a week. The variables of interest include calories, fat, sugary drinks, fruit and vegetable intakes. The higher scores indicate higher caloric, fat, sugary drinks, fruit and vegetable intakes.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Physical Activity	Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators will distribute the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (= 10 hours/per day). The higher score, the higher physical activity.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Physical Activity	Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators will distribute the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (= 10 hours/per day). The higher score, the higher physical activity.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Physical Activity	Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators will distribute the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (= 10 hours/per day). The higher score, the higher physical activity.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Autonomous Motivation for Stress Management	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for stress management.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Autonomous Motivation for Healthy Eating	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for Healthy Eating.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Autonomous Motivation for Physical Activity	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for Physical Activity.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Autonomous Motivation for Stress Management	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Stress Management (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for Stress Management.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Autonomous Motivation for Healthy Eating	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for Healthy Eating.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Autonomous Motivation for Physical Activity	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for physical activity.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Autonomous Motivation for Stress Management	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items); Values are: 1 - Not At AllTrue, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for stress managment.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Autonomous Motivation for Healthy Eating	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for Healthy Eating	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Autonomous Motivation for Physical Activity	Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items); Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True; The investigators will sum 6 items to create a composite score, ranging from 6 to 42.; Higher scores indicate higher autonomous motivation for Physical Activity.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Coping Self-efficacy	Will be measured using a "Survey for Coping Self-efficacy" (10 items); Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum 10 items to create a composite score, ranging from 10 to 40.; Higher scores indicate higher coping self-efficacy.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Coping Self-efficacy	Will be measured using a "Survey for Coping Self-efficacy" (10 items); Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum 10 items to create a composite score, ranging from 10 to 40.; Higher scores indicate higher coping self-efficacy.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Coping Self-efficacy	Will be measured using a "Survey for Coping Self-efficacy" (10 items); Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum 10 items to create a composite score, ranging from 10 to 40.; Higher scores indicate higher coping self-efficacy.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Healthy Eating Self-efficacy	Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items); Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident.; The investigators will sum all 8 items to create a composite score, ranging from 8 to 32.; The higher score, the higher healthy eating self-efficacy.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Healthy Eating Self-efficacy	Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items); Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum all 8 items to create a composite score, ranging from 8 to 32.; The higher score, the higher healthy eating self-efficacy.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Healthy Eating Self-efficacy	Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items); Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Physical Activity Self-efficacy	Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity.; Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Physical Activity Self-efficacy	Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity.; Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Physical Activity Self-efficacy	Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity.; Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident; The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Emotion Regulation	Will be measured using the Emotion Regulation Questionnaire (10 items) that assess emotion regulatory process using reappraisal, suppression and regulating negative emotion. The questionnaire has 2 subscales: reappraisal (6 items, items 1-6) and suppression (4 items, items 7-10, 4 ); Values are: 1 - Strongly Disagree, 2 - Mostly Disagree, 3 - Somewhat Disagree, 4 - Neither Agree or Disagree, 5 - Somewhat Agree, 6 - Mostly Agree, 7 - Strongly Agree; The investigators will sum 6 items to create a composite score for reappraisal, ranging from 6 to 42.; The higher score, the higher appraisal.; The investigators will sum 4 items to create a composite score for suppression, ranging from 4 to 28.; The higher score, the higher suppression.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Emotion Regulation	Will be measured using the Emotion Regulation Questionnaire (10 items) that assess emotion regulatory process using reappraisal, suppression and regulating negative emotion. The questionnaire has 2 subscales: reappraisal (6 items, items 1-6) and suppression (4 items, items 7-10, 4 ); Values are: 1 - Strongly Disagree, 2 - Mostly Disagree, 3 - Somewhat Disagree, 4 - Neither Agree or Disagree, 5 - Somewhat Agree, 6 - Mostly Agree, 7 - Strongly Agree; The investigators will sum 6 items to create a composite score for reappraisal, ranging from 6 to 42.; The higher score, the higher appraisal.; The investigators will sum 4 items to create a composite score for suppression, ranging from 4 to 28.; The higher score, the higher suppression.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Emotion Regulation	Will be measured using the Emotion Regulation Questionnaire (10 items) that assess emotion regulatory process using reappraisal, suppression and regulating negative emotion. The questionnaire has 2 subscales: reappraisal (6 items, items 1-6) and suppression (4 items, items 7-10, 4 ); Values are: 1 - Strongly Disagree, 2 - Mostly Disagree, 3 - Somewhat Disagree, 4 - Neither Agree or Disagree, 5 - Somewhat Agree, 6 - Mostly Agree, 7 - Strongly Agree; The investigators will sum 6 items to create a composite score for reappraisal, ranging from 6 to 42.; The higher score, the higher appraisal.; The investigators will sum 4 items to create a composite score for suppression, ranging from 4 to 28.; The higher score, the higher suppression.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Perceived Stress	Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful.; Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often; The investigators will sum 10 items to create a composite score, ranging from 0 to 40.; The higher score, the higher levels of perceived stress.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Perceived Stress	Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful.; Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often; The investigators will sum 10 items to create a composite score, ranging from 0 to 40.; The higher score, the higher levels of perceived stress.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Perceived Stress	Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful.; Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often; The investigators will sum 10 items to create a composite score, ranging from 0 to 40.; The higher score, the higher levels of perceived stress.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Change in Executive Function	Will be measured using The Behavior Rating Inventory of Executive Function-Adults (BRIEF-A, 75 items). This survey measures an adult's executive function in her everyday environment: for example, inhibitory control, self-monitoring, plan/organization, and organization of materials.; Values are: 0 - Never, 1 - Sometimes, 2 - Often; The investigators will sum 75 items to create a composite score, ranging from 0 to 150.; The higher score, the lower executive function.	Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Secondary	Change in Executive Function	Will be measured using The Behavior Rating Inventory of Executive Function-Adults (BRIEF-A, 75 items). This survey measures an adult's executive function in her everyday environment: for example, inhibitory control, self-monitoring, plan/organization, and organization of materials.; Values are: 0 - Never, 1 - Sometimes, 2 - Often; The investigators will sum 75 items to create a composite score, ranging from 0 to 150.; The higher score, the lower executive function.	24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Secondary	Change in Executive Function	Will be measured using The Behavior Rating Inventory of Executive Function-Adults (BRIEF-A, 75 items). This survey measures an adult's executive function in her everyday environment: for example, inhibitory control, self-monitoring, plan/organization, and organization of materials.; Values are: 0 - Never, 1 - Sometimes, 2 - Often; The investigators will sum 75 items to create a composite score, ranging from 0 to 150.; The higher score, the lower executive function.	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary	Acceptability	Investigators will ask participants to evaluate the following: the usefulness (12 items) and satisfaction (12 items) of each intervention component.; Values are: 1 - not useful at all/not satisfy at all, 2, 3, 4 - very useful/very satisfy.; The investigators will sum the 12 items to create a composite score, ranging from 12 to 48.; The higher the score, the higher acceptability.	35-37 week-gestation (T3)
Secondary	Process evaluation	Investigators will use 8 items to conduct process evaluation. Investigators will ask all study participants' receipt of stress or emotion management, healthy eating, and physical activity counseling from their clinicians, midwifes and dietitians (Yes = 1/No =0). If yes, they will be asked about the frequency and length. Participants will also be asked if they have joined/received other programs to manage stress better, eat healthier, and be more physically active.; The investigators will sum 8 items to create a composite score, ranging from 0 to 8). The higher score, the more consultation received from clinicians, midwifes and dietitians.	35-37 week-gestation (T3)