100 Participants Needed

Lifestyle Program for Obesity in Pregnancy

(Healthy Mamas Trial)

Recruiting at 1 trial location
MS
AD
LM
Overseen ByLeanne M Redman, Ph.D.
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Pennington Biomedical Research Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.

Will I have to stop taking my current medications?

The trial requires that you stop using medications and supplements known to affect body weight, including over-the-counter options for weight loss.

Is the Lifestyle Program for Obesity in Pregnancy safe for humans?

The studies on lifestyle programs for obesity in pregnancy, which focus on nutrition and physical activity, show they are generally safe for pregnant women, as they help limit weight gain without increasing pregnancy complications.12345

How does the Weight Maintenance Group treatment for obesity in pregnancy differ from other treatments?

The Weight Maintenance Group treatment is unique because it focuses on a lifestyle intervention that includes nutrition and physical activity to help pregnant women with obesity limit their weight gain, rather than relying on medication or surgical options. This approach aims to reduce gestational weight gain and improve maternal and perinatal outcomes without the use of drugs.23467

What data supports the effectiveness of the treatment for the Lifestyle Program for Obesity in Pregnancy?

Research shows that lifestyle interventions, which include nutrition and physical activity, can help pregnant women with obesity limit excessive weight gain during pregnancy. These programs have been effective in reducing gestational weight gain, which is important for improving pregnancy outcomes.12345

Who Is on the Research Team?

Leanne M Redman

Leanne M Redman, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to eat the study foods
I am pregnant and not more than 15 weeks along.
I am willing to be randomly assigned to a treatment group.
See 4 more

Exclusion Criteria

You use tobacco, drugs, or alcohol.
I am not taking any medications or supplements for weight loss.
Have pre-existing diabetes
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a lifestyle program supporting weight maintenance and fat mass loss during pregnancy

From early pregnancy to delivery
Bi-weekly visits until 20 weeks gestation, then monthly until delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 weeks postpartum
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Weight Maintenance Group
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight Maintenance GroupExperimental Treatment1 Intervention
Group II: Provider Directed GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials
314
Recruited
183,000+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

California Polytechnic State University-San Luis Obispo

Collaborator

Trials
33
Recruited
3,400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

In a study involving 1,150 pregnant women with overweight or obesity, lifestyle interventions focusing on diet and physical activity significantly reduced the percentage of women experiencing excess gestational weight gain (GWG) compared to standard care (61.8% vs. 75.0%).
The total GWG was also lower in the intervention group (8.1 kg) compared to the standard care group (9.7 kg), indicating that these behavioral interventions can effectively manage weight gain during pregnancy without negatively impacting pregnancy outcomes like preeclampsia or gestational diabetes.
Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis.Peaceman, AM., Clifton, RG., Phelan, S., et al.[2022]
A lifestyle intervention program for pregnant women with obesity significantly reduced gestational weight gain (GWG) in the per-protocol population, with an average gain of 8.9 kg compared to 11.2 kg in the control group.
The intervention also led to less weight retention postpartum, with women in the intervention group losing an average of 0.3 kg compared to a gain of 1.6 kg in the control group, indicating that lifestyle changes can have lasting benefits beyond pregnancy.
Mighty Mums - a lifestyle intervention at primary care level reduces gestational weight gain in women with obesity.Haby, K., Berg, M., Gyllensten, H., et al.[2022]
A group lifestyle intervention for 60 obese pregnant women led to a higher number of participants meeting the recommended weight gain guidelines compared to controls (35 vs 24), suggesting the intervention's effectiveness.
While the mean gestational weight gain was lower in the intervention group, it wasn't statistically significant; however, attending more educational sessions was linked to a decrease in total weight gained.
The lifestyle modification project: limiting pregnancy weight gain in obese women.Shirazian, T., Faris, BS., Fox, NS., et al.[2015]

Citations

Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. [2022]
Mighty Mums - a lifestyle intervention at primary care level reduces gestational weight gain in women with obesity. [2022]
The lifestyle modification project: limiting pregnancy weight gain in obese women. [2015]
Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP). [2014]
A Pilot Randomized Controlled Trial of a Technology-Based Approach for Preventing Excess Weight Gain during Pregnancy among Women with Overweight. [2023]
Gestational weight change in women attending a group antenatal program aimed at addressing obesity in pregnancy in New South Wales, Australia. [2014]
Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. [2023]
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