Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women (MAWI)
Primary Purpose
Obesity, Weight Gain, Maternal
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal-Oriented Episodic Future Thinking
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring pregnant women, intervention
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.
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
Usual Prenatal Care
Arm 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.
The usual prenatal care group will receive usual care from their providers
Outcomes
Primary Outcome Measures
Change in Body weight
Data extracted from electronic medical record
Change in Body weight
Data extracted from electronic medical record
Change in Body weight
Data extracted from electronic medical record
Secondary Outcome Measures
Change in Gestational Diabetes status
Data extracted from electronic medical record
Change in Gestational Hypertension status
Data extracted from electronic medical record
Mode of Delivery
Data extracted from electronic medical record
Newborn body weight
Data extracted from electronic medical record.
Gestational age at birth
Data extracted from electronic medical record.
The higher value, the higher gestational age
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04623008
Brief Title
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Acronym
MAWI
Official Title
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Gain, Maternal
Keywords
pregnant women, intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual Prenatal Care
Arm Type
No Intervention
Arm Description
The usual prenatal care group will receive usual care from their providers
Intervention Type
Behavioral
Intervention Name(s)
Goal-Oriented Episodic Future Thinking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body weight
Description
Data extracted from electronic medical record
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Body weight
Description
Data extracted from electronic medical record
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Body weight
Description
Data extracted from electronic medical record
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Secondary Outcome Measure Information:
Title
Change in Gestational Diabetes status
Description
Data extracted from electronic medical record
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Gestational Hypertension status
Description
Data extracted from electronic medical record
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Mode of Delivery
Description
Data extracted from electronic medical record
Time Frame
35-37 week-gestation (T3)
Title
Newborn body weight
Description
Data extracted from electronic medical record.
Time Frame
35-37 week-gestation (T3)
Title
Gestational age at birth
Description
Data extracted from electronic medical record.
The higher value, the higher gestational age
Time Frame
35-37 week-gestation (T3)
Title
Change in Dietary Intake Behaviors
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Dietary Intake Behaviors
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Dietary Intake Behaviors
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Physical Activity
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Physical Activity
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Physical Activity
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Autonomous Motivation for Stress Management
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Autonomous Motivation for Healthy Eating
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Autonomous Motivation for Physical Activity
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Autonomous Motivation for Stress Management
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Autonomous Motivation for Healthy Eating
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Autonomous Motivation for Physical Activity
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Autonomous Motivation for Stress Management
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Autonomous Motivation for Healthy Eating
Description
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
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Autonomous Motivation for Physical Activity
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Coping Self-efficacy
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Coping Self-efficacy
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Coping Self-efficacy
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Healthy Eating Self-efficacy
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Healthy Eating Self-efficacy
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Healthy Eating Self-efficacy
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Physical Activity Self-efficacy
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Physical Activity Self-efficacy
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Physical Activity Self-efficacy
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Emotion Regulation
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Emotion Regulation
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Emotion Regulation
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Perceived Stress
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Perceived Stress
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Perceived Stress
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Change in Executive Function
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Title
Change in Executive Function
Description
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.
Time Frame
24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Title
Change in Executive Function
Description
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.
Time Frame
Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Title
Acceptability
Description
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.
Time Frame
35-37 week-gestation (T3)
Title
Process evaluation
Description
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.
Time Frame
35-37 week-gestation (T3)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants need to be pregnant women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Wei Chang, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
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