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N/A N=70 Randomized Prevention

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

Obesity · Weight Gain, Maternal

Enrolled (actual)
70
Serious AEs
4.3%
Results posted
Jan 2025
Primary outcome: Primary: Percent Change in Body Weight — 10.9; 9.6 percentage change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Goal-Oriented Episodic Future Thinking (Behavioral)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Ohio State University
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Body Weight
24.9; 23.5
PRIMARY
Percent Change in Body Weight
24.9; 23.5
PRIMARY
Percent Change in Body Weight
24.9; 23.5
SECONDARY
Percentage of Participants Diagnosed With Gestational Diabetes
4; 5
SECONDARY
Percentage of Participants Diagnosed With Gestational Hypertension
4; 2
SECONDARY
Percentage of Participants With Cesarean Delivery
9; 9
SECONDARY
Newborn Body Weight
3493; 3503
SECONDARY
Percentage of Participants With Premature (<37 Weeks Gestation) Births
0; 3
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
98.34; -217
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Fat (gm)
9.89; -0.84
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)
0.63; -0.25
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)
0.18; 0.22
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)
2.35; -2.99
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
98.34; -217
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)
15.18; -11.1
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)
0.12; 0.19
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)
-0.11; 0.08
SECONDARY
Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)
3.08; -2.28
SECONDARY
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
3.06; 1.13
SECONDARY
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
3.06; 1.13
SECONDARY
Change in Autonomous Motivation for Physical Activity
-1.60; -1.26
SECONDARY
Change in Autonomous Motivation for Physical Activity
-1.60; -1.26
SECONDARY
Change in Autonomous Motivation for Stress Management
-0.27; -0.68
SECONDARY
Change in Autonomous Motivation for Stress Management
-0.27; -0.68
SECONDARY
Change in Autonomous Motivation for Healthy Eating
-0.93; -2.95
SECONDARY
Change in Autonomous Motivation for Healthy Eating
-0.93; -2.95
SECONDARY
Change in Healthy Eating Self-efficacy
2.80; 0.84
SECONDARY
Change in Healthy Eating Self-efficacy
2.80; 0.84
SECONDARY
Change in Coping Self-efficacy
4.07; 1.21
SECONDARY
Change in Coping Self-efficacy
4.07; 1.21
SECONDARY
Change in Physical Activity Self-efficacy
1.40; 2.00
SECONDARY
Change in Physical Activity Self-efficacy
1.40; 2.00
SECONDARY
Change in Emotion Regulation
2.73; -1.53
SECONDARY
Change in Emotion Regulation
2.73; -1.53
SECONDARY
Change in Perceived Stress
-1.60; 0.72
SECONDARY
Change in Perceived Stress
-1.60; 0.72
SECONDARY
Change in Executive Function - Behavior Regulation
0.36; 1.88
SECONDARY
Change in Executive Function - Behavioral Regulation
-0.43; -0.17
SECONDARY
Change in Executive Function - Metacognition
-5.86; -1.78
SECONDARY
Change in Executive Function - Metacognition
-5.86; -1.78

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)

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04623008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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