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Behavioral Intervention

Lifestyle Program for Obesity in Pregnancy (Healthy Mamas Trial)

N/A

Recruiting

Led By Leanne M Redman, Ph.D.

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are pregnant less than or equal to 15 weeks gestation at screening

Have a body mass index between 35.0 and 55.0 inclusive

Must not have

Have pre-existing hypertension

Have severe anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13-16 weeks gestation and 35-37 weeks gestation

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a lifestyle program on pregnant women with obesity. The program is designed to help with weight maintenance and fat loss, and researchers will track changes in weight, fat mass, cardiometabolic risk factors, and safety measures like fetal and neonatal growth. They will also study the factors that affect how well the program works, and whether the fat loss leads to better obstetrical outcomes.

Who is the study for?

This trial is for pregnant women with obesity, having a BMI between 35.0 and 55.0, who are less than or equal to 15 weeks into their pregnancy with a single baby. They must be cleared by their prenatal care provider, willing to eat study foods, and agree to random group assignment. Excluded are those with mental health issues, eating disorders, certain medical histories like pre-eclampsia or diabetes, substance use, or planning to move soon.

What is being tested?

The trial tests a lifestyle program aimed at maintaining weight and reducing fat mass during pregnancy in obese women. It examines the impact on maternal weight/fat loss and cardiometabolic risk factors while ensuring fetal safety. The study also looks at how this intervention might reduce adverse obstetrical outcomes.

What are the potential side effects?

Since this is a lifestyle-based intervention focusing on diet and possibly exercise rather than medication or surgery, side effects may include typical discomforts associated with dietary changes such as gastrointestinal upset but should generally be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am pregnant and not more than 15 weeks along.

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My BMI is between 35.0 and 55.0.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high blood pressure.

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I have severe anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13-16 weeks gestation and 35-37 weeks gestation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13-16 weeks gestation and 35-37 weeks gestation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13-16 weeks gestation and 35-37 weeks gestation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body weight change from early pregnancy to approximately 2 weeks postpartum

Body weight change from early pregnancy to end of pregnancy

Fat mass change from early pregnancy to approximately 2 weeks postpartum

+5 more

Awards & 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: Weight Maintenance GroupExperimental Treatment1 Intervention

Individuals in this group will receive all aspects of the Provider Directed Group plus a comprehensive behavioral fat mass loss intervention with food provision. Individuals in this group will be provided foods to eat to support weight maintenance and loss of body fat throughout pregnancy. They will be asked to attend two behavioral counseling sessions at the beginning of the study to help learn the program and set goals. They will return for brief visits with a lifestyle counselor every two weeks until 20 weeks gestation and at least once a month until delivery. Individuals will be provided a scale to help keep track of weight during pregnancy.

Group II: Provider Directed GroupActive Control1 Intervention

Individuals in this group will receive what is standard practice by their prenatal care providers during pregnancy. In addition, individuals in this group will be asked to attend a brief session at the time of randomization to familiarize with the study and what is expected. They will also be provided with materials describing healthy behaviors in pregnancy.

0 / 4Eligibility criteria met