ObesityMAWINCT04623008
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
A study testing Goal-Oriented Episodic Future Thinking in people with Obesity and Weight Gain, Maternal, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain, Maternal
- What is being tested?
- Goal-Oriented Episodic Future Thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- Obesity, Weight Gain, Maternal
- Being tested
- Goal-Oriented Episodic Future Thinking
- Keywords
- pregnant women, intervention
- Medical subject headings
- Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Oriented Episodic Future ThinkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Goal-Oriented Episodic Future Thinking |
| Usual Prenatal Care | No intervention | The usual prenatal care group will receive usual care from their providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight
Data extracted from electronic medical record
Measured: 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
Measured: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percent Change in Body Weight
Data extracted from electronic medical record
Measured: 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
Data extracted from electronic medical record. Percentage of participants who were diagnosed with Gestational Diabetes during the study timeframe.
Measured: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percentage of Participants Diagnosed With Gestational Hypertension
Data extracted from electronic medical record. Percentage of participants diagnosed with Gestational Hypertension in the study timeframe.
Measured: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percentage of Participants With Cesarean Delivery
Data extracted from electronic medical record. Percentage of participants who experienced Cesarean Delivery.
Measured: 35-37 week-gestation (T3)
Newborn Body Weight
Data extracted from electronic medical record. Newborn Body Weight taken at birth.
Measured: 35-37 week-gestation (T3)
Percentage of Participants With Premature (<37 Weeks Gestation) Births
Gestational age for each participant was extracted from electronic medical record and births before 37 weeks gestation were considered to be premature. The number of premature births was averaged within the study groups.
Measured: 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Fat (gm)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetables (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetable (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)
Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars (teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed.
Only participants who completed 2 days worth of dietary data were included in this analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day).
The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical.
Only participants who completed the minimum requirement for reporting [wear at the wrist at least seven consecutive days (≥ 10 hours/per day)] were included in the analysis.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day).
The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods.
Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical.
Only participants who completed the minimum requirement for reporting [wear at the wr
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Emotion Regulation
The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Emotion Regulation
The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
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.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Executive Function - Behavior Regulation
The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T2 to evaluate the effect of the intervention.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Executive Function - Behavioral Regulation
The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T3 to evaluate the effect of the intervention.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Executive Function - Metacognition
The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function [31]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T2 to evaluate the effect of the intervention.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Executive Function - Metacognition
The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function [31]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T3 to evaluate the effect of the intervention.
Measured: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Feb 2021
- Primary completion30 Jan 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Wei Chang, Ohio State University
- Investigators
- Mei-Wei Chang, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623008
- Sponsor's protocol ID
- 2019H0441
- Acronym
- MAWI
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2020
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT04623008
- Acronym / sponsor ID
- MAWI / 2019H0441
- Conditions
- Obesity, Weight Gain, Maternal
- Keywords
- pregnant women, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-Oriented Episodic Future Thinking (GOEFT) Intervention | Experimental | Behavioral: Goal-Oriented Episodic Future ThinkingIn 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. |
| Usual Prenatal Care | No intervention | –The usual prenatal care group will receive usual care from their providers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-Oriented Episodic Future ThinkingIndividuals 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. | Behavioural | Goal-Oriented Episodic Future Thinking (GOEFT) Intervention |
Primary outcome
Percent Change in Body Weight
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Data extracted from electronic medical record
Percent Change in Body Weight
Time frame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Data extracted from electronic medical record
Percent Change in Body Weight
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Data extracted from electronic medical record
37 secondary outcomes
Percentage of Participants Diagnosed With Gestational Diabetes
Time frame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percentage of Participants Diagnosed With Gestational Hypertension
Time frame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percentage of Participants With Cesarean Delivery
Time frame: 35-37 week-gestation (T3)
Newborn Body Weight
Time frame: 35-37 week-gestation (T3)
Percentage of Participants With Premature (<37 Weeks Gestation) Births
Time frame: 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Fat (gm)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Autonomous Motivation for Physical Activity
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Autonomous Motivation for Physical Activity
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Autonomous Motivation for Stress Management
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Autonomous Motivation for Stress Management
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Autonomous Motivation for Healthy Eating
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Autonomous Motivation for Healthy Eating
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Healthy Eating Self-efficacy
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Healthy Eating Self-efficacy
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Coping Self-efficacy
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Coping Self-efficacy
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Physical Activity Self-efficacy
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Physical Activity Self-efficacy
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Emotion Regulation
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Emotion Regulation
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Perceived Stress
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Perceived Stress
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Executive Function - Behavior Regulation
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Executive Function - Behavioral Regulation
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Executive Function - Metacognition
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Executive Function - Metacognition
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Wei Chang, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Oriented Episodic Future Thinking in people with Obesity and Weight Gain, Maternal, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight (time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.