Lifestyle Program for Obesity in Pregnancy

(Healthy Mamas Trial)

Recruiting at 1 trial location

Overseen By Leanne M Redman, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Weight loss medications

Disqualifiers: Smoking, Diabetes, Hypertension, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: From early pregnancy to delivery

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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. ^{1 2 3 4 5}

Who Is on the Research Team?

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.

Exclusion Criteria

You use tobacco, drugs, or alcohol.

I am not taking any medications or supplements for weight loss.

Have pre-existing diabetes

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?

Group I: Weight Maintenance Group Experimental Treatment 1 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 Group Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lifestyle modification project: limiting pregnancy weight gain in obese women. Shirazian, T., Faris, BS., Fox, NS., et al.[2015]

The Lifestyle in Pregnancy intervention, which included diet counseling and physical activities, significantly reduced insulin resistance in obese pregnant women compared to a control group, indicating improved metabolic health during pregnancy.

Despite the intervention leading to lower gestational weight gain, there were no significant changes in glucose or lipid metabolism between the intervention and control groups, suggesting that weight management alone may not influence these metabolic parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP). Vinter, CA., Jørgensen, JS., Ovesen, P., et al.[2014]

A pilot study involving 41 pregnant women with overweight or obesity found that a lifestyle modification program delivered via phone did not significantly reduce gestational weight gain compared to standard treatment.

Both the intervention and standard treatment groups had similar outcomes in terms of weight gain during pregnancy and postpartum, suggesting that more intensive or earlier interventions may be needed to effectively manage weight during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of a Technology-Based Approach for Preventing Excess Weight Gain during Pregnancy among Women with Overweight. Chao, AM., Srinivas, SK., Studt, SK., et al.[2023]

A group antenatal program in New South Wales, Australia, aimed at helping obese pregnant women manage their weight gain showed that 54% of participants either gained the recommended amount of weight or less, indicating potential effectiveness in limiting gestational weight gain.

The study found that women with higher pre-pregnancy BMIs had significantly lower gestational weight gain, suggesting that the program may help obese women achieve better weight management during pregnancy, although more evidence is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational weight change in women attending a group antenatal program aimed at addressing obesity in pregnancy in New South Wales, Australia. Raymond, JE., Foureur, MJ., Davis, DL.[2014]

Managing obesity in women of childbearing age is crucial, as it involves optimizing weight and medical conditions before and during pregnancy to ensure both maternal and fetal health.

Maternal obesity can lead to negative metabolic effects in offspring, contributing to a cycle of obesity that can affect future generations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. Dutton, H., Borengasser, SJ., Gaudet, LM., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Mighty Mums - a lifestyle intervention at primary care level reduces gestational weight gain in women with obesity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The lifestyle modification project: limiting pregnancy weight gain in obese women. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP). [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of a Technology-Based Approach for Preventing Excess Weight Gain during Pregnancy among Women with Overweight. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Gestational weight change in women attending a group antenatal program aimed at addressing obesity in pregnancy in New South Wales, Australia. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. [2023]