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Health Interventions for Pregnancy Weight Management (HABIT Trial)
N/A
Waitlist Available
Led By Michele Levine, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are English speaking
Have a prenatal BMI ≥ 25
Must not have
Previous bariatric surgery in the previous 3 years
Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year postpartum
Awards & highlights
No Placebo-Only Group
Summary
This trial will test weight management programs for overweight or obese pregnant women. The programs aim to help women control their weight by teaching them self-regulation skills and providing educational support. The goal is to see if these programs can help women maintain a healthier weight during and after pregnancy.
Who is the study for?
This trial is for English-speaking pregnant women with a BMI ≥ 25, who are less than 18 weeks and 4 days into a singleton pregnancy. It's not suitable for those with acute psychiatric symptoms needing immediate treatment, multiple gestations, preexisting diabetes, recent bariatric surgery within the last three years, or on weight-affecting medications.
What is being tested?
The study tests two interventions: HABITpreg during pregnancy and HABITpost after delivery. Participants will be randomly assigned to either receive these interventions at specific times or continue with their usual care to see how it affects weight gain during and after pregnancy.
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medication, side effects may include typical discomforts related to changes in diet or exercise routines but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English.
Select...
My BMI was 25 or higher before I got pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had weight loss surgery within the last 3 years.
Select...
I do not have urgent mental health issues needing immediate care.
Select...
I have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maternal weight
Secondary study objectives
Depressive symptoms
Maternal inflammatory markers
Maternal lipids
Other study objectives
Gestational Weight Gain
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: TAUpreg; HABITpostExperimental Treatment1 Intervention
Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period.
Group II: HABITpreg; TAUpostExperimental Treatment1 Intervention
Participants will receive study intervention during pregnant and treatment as usual postpartum.
Group III: HABITpreg, HABITpostExperimental Treatment2 Interventions
Participants will receive study intervention during pregnancy and study intervention during the postpartum period.
Group IV: TAUpreg; TAUpostActive Control1 Intervention
Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HABITpost
2017
N/A
~320
HABITpreg
2017
N/A
~320
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for managing weight gain during pregnancy primarily involve behavioral and nutritional strategies. Behavioral strategies include lifestyle modifications such as increased physical activity and structured exercise programs.
Nutritional strategies focus on balanced diets that limit excessive calorie intake while ensuring adequate nutrient supply. These interventions are crucial for maintaining a healthy weight, supporting fetal development, and reducing the risk of complications like gestational diabetes, hypertension, and large-for-gestational-age infants.
By controlling weight gain, these strategies help improve overall pregnancy outcomes and maternal health.
Antenatal interventions for overweight or obese pregnant women: a systematic review of randomised trials.
Antenatal interventions for overweight or obese pregnant women: a systematic review of randomised trials.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,773 Previous Clinical Trials
16,352,318 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,913 Previous Clinical Trials
47,757,437 Total Patients Enrolled
Michele Levine, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English.I had weight loss surgery within the last 3 years.My BMI was 25 or higher before I got pregnant.I do not have urgent mental health issues needing immediate care.I have diabetes.I am not on medications that can change my weight.
Research Study Groups:
This trial has the following groups:- Group 1: HABITpreg; TAUpost
- Group 2: HABITpreg, HABITpost
- Group 3: TAUpreg; HABITpost
- Group 4: TAUpreg; TAUpost
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.
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