Lifestyle Program for Obesity in Pregnancy

(Healthy Mamas Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a lifestyle program designed to help pregnant women with obesity manage their weight and reduce fat during pregnancy. Researchers aim to assess the impact on the mother's weight, fat, and health risks, as well as the baby's growth and the likelihood of pregnancy complications such as gestational diabetes or high blood pressure. Participants will either follow a special program with food and counseling (the Weight Maintenance Group) or continue with their regular prenatal care. Women who are less than 15 weeks pregnant, have a BMI between 31 and 55, and are open to adopting new eating habits may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how lifestyle changes can benefit both mother and baby during pregnancy.

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.

What prior data suggests that this lifestyle program is safe for pregnant women with obesity?

Research has shown that lifestyle programs can help pregnant women with obesity manage their weight. These programs are generally safe and can lead to less weight gain during pregnancy. For instance, one study found that these programs reduced weight gain, lowering the risk of issues like gestational diabetes and high blood pressure.

Reports of serious side effects from these lifestyle programs do not exist. They focus on healthy eating and regular check-ins, which most people find easy to follow. Participants receive support to maintain a healthy weight, reducing the risk of complications for both mother and baby. Overall, evidence suggests that these programs are safe and can help manage weight during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Program for Obesity in Pregnancy because it offers a comprehensive behavioral approach that combines direct food provision with regular lifestyle counseling, a step beyond standard prenatal care. Unlike typical methods that rely heavily on general dietary advice and physical activity recommendations, this program provides specific foods to support weight maintenance and fat loss throughout pregnancy. By integrating personalized counseling sessions and continuous weight monitoring, it aims to create sustainable lifestyle changes during pregnancy, potentially leading to healthier outcomes for both the mother and the baby.

What evidence suggests that this lifestyle program is effective for obesity in pregnancy?

Research has shown that lifestyle programs can help manage obesity in pregnant women. In this trial, the Weight Maintenance Group will receive a comprehensive behavioral fat mass loss intervention with food provision, aiming to support weight maintenance and body fat loss throughout pregnancy. Studies have found that such programs can reduce negative outcomes for both mother and baby. For example, lifestyle changes can lower the risk of having a very large baby and improve overall pregnancy health. Programs focusing on diet and exercise have successfully helped women lose weight after giving birth. These findings suggest that maintaining a healthy weight during pregnancy benefits both mother and child. ^{1 4 6 7 8}

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

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]

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 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]

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 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]

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