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Behavioral Intervention
Mental Imagination for Excessive Pregnancy Weight Gain (MAWI Trial)
N/A
Waitlist Available
Led By Mei-Wei Chang, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-27 week-gestation (t2) to 35-37 week-gestation (t3)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a program of stress management, healthy eating, and physical activity can help prevent excessive weight gain in pregnant women who are overweight or obese.
Who is the study for?
This trial is for overweight or obese pregnant women aged 18-45, living in Franklin County, with access to a smartphone and internet. They must be ≤13 weeks pregnant with a single fetus, have a BMI of 25.0-45.0 kg/m2, and plan to deliver at OSU Wexner Medical Center. Exclusions include hypertension, diabetes, serious diseases like cancer or renal disease, past bariatric surgery, severe psychological disorders, history of multiple miscarriages or eating disorders.
What is being tested?
The 'Moms Are Worth It' study tests if Goal-Oriented Episodic Future Thinking can prevent excessive weight gain during pregnancy by promoting stress management, healthy eating habits and physical activity over a 20-week period through web sessions and health coaching.
What are the potential side effects?
Since the intervention involves lifestyle changes rather than medication there may not be direct side effects; however participants might experience discomfort adjusting to new diet or exercise routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-27 week-gestation (t2) to 35-37 week-gestation (t3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-27 week-gestation (t2) to 35-37 week-gestation (t3)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Body weight
Secondary study objectives
Acceptability
Change in Autonomous Motivation for Healthy Eating
Change in Autonomous Motivation for Physical Activity
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Goal-Oriented Episodic Future Thinking (GOEFT) InterventionExperimental Treatment1 Intervention
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.
Group II: Usual Prenatal CareActive Control1 Intervention
The usual prenatal care group will receive usual care from their providers
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,642 Total Patients Enrolled
23 Trials studying Obesity
3,884 Patients Enrolled for Obesity
Mei-Wei Chang, PhDPrincipal Investigator - Ohio State University
Ohio State University
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Obesity
30 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with high blood pressure and/or type 1 or type 2 diabetes.You have experienced three or more miscarriages in the past, according to what you have personally reported.You are unable to walk due to medical reasons.You have had or currently have an eating disorder.You have used drugs or alcohol excessively in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
- Group 2: Usual Prenatal Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.