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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13-16 weeks gestation and 35-37 weeks gestation
Awards & highlights

Healthy Mamas Trial 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.Check my eligibility
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.See study design
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.

Healthy Mamas Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant and not more than 15 weeks along.
Select...
My BMI is between 35.0 and 55.0.

Healthy Mamas Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Healthy Mamas 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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
974 Previous Clinical Trials
7,385,812 Total Patients Enrolled
29 Trials studying Obesity
9,246 Patients Enrolled for Obesity
Pennington Biomedical Research CenterLead Sponsor
305 Previous Clinical Trials
181,936 Total Patients Enrolled
64 Trials studying Obesity
117,465 Patients Enrolled for Obesity
California Polytechnic State University-San Luis ObispoOTHER
29 Previous Clinical Trials
3,187 Total Patients Enrolled
8 Trials studying Obesity
1,299 Patients Enrolled for Obesity

Media Library

Weight Maintenance Group (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04731688 — N/A
Obesity Research Study Groups: Weight Maintenance Group, Provider Directed Group
Obesity Clinical Trial 2023: Weight Maintenance Group Highlights & Side Effects. Trial Name: NCT04731688 — N/A
Weight Maintenance Group (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731688 — N/A

Frequently Asked Questions

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

Is it possible for me to partake in this research?

"This medical study requires that 100 participants aged 18-45 with obesity must also fulfill specific conditions, such as enrolling their newborn in the trial and having a BMI range of 35.0 to 55.0 inclusive. Furthermore, they must receive approval from an obstetrician for participation and be randomized into one of two groups."

Answered by AI

Are there still vacancies for participants in this medical experiment?

"As per clinicaltrials.gov, this medical trial is presently accepting patients; the initial posting was on March 10th 2021 and records were last updated on September 26th 2022."

Answered by AI

Are elderly individuals being considered as candidates in this research?

"This clinical trial is only available to patients between the ages of 18 and 45. On the other hand, 242 trials are accessible for participants below 18 years old, while 658 studies cater for those above 65."

Answered by AI

What is the participant quota for this clinical investigation?

"Yes, the records hosted on clinicaltrials.gov verify that this medical trial is presently enrolling patients. The study was first advertised on March 10th 2021 and most recently updated September 26th 2022; it currently seeks 100 individuals at 2 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
California
How old are they?
18 - 65
What site did they apply to?
California Polytechnic State University
Pennington Biomedical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Does it include a diet plan and/or medication?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I just eat too much sugar. I have struggled with keep weight off all my life.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Leanne Redman 2021. "A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04731688.
All > Weight Gain > Pregnancy
~35 spots leftby Dec 2025
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