What side effects are associated with this type of intervention?

Common treatments for managing gestational weight gain primarily involve behavioral and nutritional strategies. Dietary modifications can sometimes lead to nutrient deficiencies if not well-balanced. Physical activity is generally safe but may cause musculoskeletal discomfort or fatigue. Pharmacological interventions, though less common, can have side effects such as gastrointestinal disturbances or metabolic imbalances. Overall, these strategies are aimed at promoting healthy weight gain and minimizing risks to both mother and fetus.

What prior FDA approvals exist?

FDA-approved treatments for weight management in the general population include GLP-1 receptor agonists such as liraglutide and semaglutide, which are effective for weight loss and offer additional benefits for glycemia and cardiovascular health. However, specific FDA approvals for weight management interventions during pregnancy are not detailed in the provided context. It is essential to consult healthcare providers for personalized treatment plans during pregnancy.

What other types of research exist?

Promising novel alternatives to traditional gestational weight management interventions for pregnancy patients in 2024 include: 1) Digital health interventions such as smartphone apps and telehealth services that provide personalized guidance and support. 2) Pharmacological options like the use of safe medications under medical supervision to manage weight gain. 3) Integrative approaches combining physical exercise, dietary therapy, and psychological support to address multiple aspects of weight management. These alternatives offer innovative ways to support pregnant women in managing their weight effectively.

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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 below

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I speak English.

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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:

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I had weight loss surgery within the last 3 years.

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I do not have urgent mental health issues needing immediate care.

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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

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

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

0 / 5Eligibility criteria met

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.