N/A
N=70
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Obesity · Weight Gain, Maternal
Bottom Line
View on ClinicalTrials.gov: NCT04623008 ↗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
| Outcome | Result | p-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.
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.