Healthy Mamas Study

Study Type

Women's Health

Study Purpose

Maternal obesity and excess weight gain in pregnancy are the leading causes of maternal and fetal complications, and more research is needed to test the health effects of lifestyle interventions in women with obesity. The purpose of the Healthy Mamas research study is to determine the health effects of a lifestyle program that supports weight maintenance during pregnancy in women with obesity.

About the Study

Study participants will complete 4 clinic visits and 3 or 4 short safety visits in the Pennington Biomedical outpatient clinic throughout pregnancy until 2 weeks postpartum.

Study participants will be randomly assigned to either the Provider Directed Group or the Weight Maintenance Group. The chance to end up in one group or the other is random and 50%. Study participants will be asked to complete the following:

  • Provider Directed Group
    • Receive standard care through their prenatal care providers during pregnancy.
  • Weight Maintenance Group
    • Receive standard care from their prenatal care providers during pregnancy.
    • Eat provided meals and snacks (at no cost to you) to support healthy weight maintenance with loss of body fat throughout pregnancy.
    • Attend behavioral counseling sessions throughout pregnancy. Study participants will be provided a scale to help keep track of their weight during pregnancy and will return the scale after pregnancy.

Study Design

Number of Visits:

  • 1 screening visit
  • 6 or 7 clinic visits during pregnancy (depending on gestational age at time of enrollment)
  • 1 clinic visit around 2 weeks postpartum

Procedures

  • Body measurements (height, weight, waist and hip circumferences)
  • Vital signs (blood pressure, pulse)
  • Questionnaires
  • Finger stick test for diabetes
  • Blood collection
  • Skinfold thickness (to measure body fat)
  • BODPOD scan (to measure body fat)
  • Total body water by urine collection
  • Physical activity monitoring
  • Diet recall
  • Fetal ultrasound
  • DXA scan (to measure amount of bone, muscle, and body fat) – around 2 weeks postpartum only

Infants born to mothers enrolled in the study will be asked to complete procedures at the clinic visit around 2 weeks postpartum. The study team will go over this information in detail.

Study Qualifications

To qualify for this study, participants should:

  • Be a woman less than 15 weeks pregnant
  • Be 18-45 years old
  • Have a Body Mass Index between 35.0 and 55.0 calculate your BMI
  • Be expecting only one baby
  • Be willing to eat study foods
  • Be willing to enroll their infant for study procedures after birth

You may not qualify for this study based on other eligibility criteria not listed. The study team will go over this information in detail.

Study Duration

Participation in this research study will last approximately 8 months.

Compensation

Participants will receive up to $400 upon completion of the study. Participants who are randomly assigned to the Weight Maintenance Group will also receive study foods at no cost.

Study Contact

If you are interested in volunteering for the Healthy Mamas study, click here to screen online, call 225-326-0546 or email moms@pbrc.edu.

If you think you may be eligible, please click the button below to screen online.

GET STARTED

Please do not fill out this questionnaire for anyone other than yourself unless you are their legal guardian.
If you know someone who may be interested please direct them to the site or have them call us directly at 225-763-3000.

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