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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 below

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I speak English.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year postpartum for reporting.

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,342,041 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,342 Total Patients Enrolled

Michele Levine, PhDPrincipal Investigator - University of Pittsburgh

University of Pittsburgh

2 Previous Clinical Trials

65 Total Patients Enrolled

Media Library

HABITpreg Clinical Trial Eligibility Overview. Trial Name: NCT03069690 — N/A

Pregnancy Research Study Groups: HABITpreg; TAUpost, HABITpreg, HABITpost, TAUpreg; HABITpost, TAUpreg; TAUpost

Pregnancy Clinical Trial 2023: HABITpreg Highlights & Side Effects. Trial Name: NCT03069690 — N/A

HABITpreg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03069690 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment currently have people joining its ranks?

"Yes, the data on clinicaltrials.gov confirms that recruitment for this trial is presently underway. It was first posted in February 1st 2017 and newly updated on February 28th 2022. 300 participants are sought from a single medical facility."

Answered by AI

To what extent is the patient population for this research expanding?

"Correct. According to the information provided on clinicaltrials.gov, this experiment is currently recruiting patients. It was first posted on February 1st 2017 and most recently updated on February 28th 2022; with a total of 300 participants needed from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Health From Pregnancy Through One Year Postpartum

Michele Levine 2017. "Optimizing Health From Pregnancy Through One Year Postpartum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03069690.

All > Obesity > Pregnancy