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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

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.

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 groups in NCT04623008
Study groupRoleWhat they receive
Goal-Oriented Episodic Future Thinking (GOEFT) InterventionExperimentalIn 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 CareNo interventionThe 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.

  1. 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)

  2. Percent Change in Body Weight

    Data extracted from electronic medical record

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

  3. 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)
  1. 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)

  2. 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)

  3. 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)

  4. Newborn Body Weight

    Data extracted from electronic medical record. Newborn Body Weight taken at birth.

    Measured: 35-37 week-gestation (T3)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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.

  1. First posted10 Nov 2020
  2. Study start1 Feb 2021
  3. Primary completion30 Jan 2023
  4. Study completion30 Dec 2023

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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MAWI Clinical Trial NCT04623008 | AzTrials