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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year postpartum
Awards & highlights
HABIT Trial Summary
This trial will study the effect of different combinations of interventions on pregnant women's weight gain. Women will be randomly assigned to receive different interventions during and after pregnancy, or usual care.
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.Check my eligibility
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.See study design
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.
HABIT Trial 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.
HABIT Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maternal weight
Secondary outcome measures
Depressive symptoms
Maternal inflammatory markers
Maternal lipids
Other outcome measures
Gestational Weight Gain
HABIT 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.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,136 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,817,936 Total Patients Enrolled
Michele Levine, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
2 Previous Clinical Trials
65 Total Patients Enrolled
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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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