Lifestyle Intervention for Pregnancy Weight Gain

Recruiting at 3 trial locations

Overseen By Monique M Hedderson, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Multiple births, Moving, Bed rest, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 9 months

1335 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mobile health intervention to help pregnant women who are overweight or obese manage weight gain during pregnancy. The intervention, called a Lifestyle Intervention, includes a mobile app, personalized text messages, and phone coaching sessions with a dietician. It aims to help participants maintain healthy weight gain as recommended by health guidelines, with additional support if needed. Ideal candidates for this trial are pregnant women with a body mass index (BMI) between 25 and 39 who have access to a smartphone. Researchers will compare participants to those receiving usual medical care to determine which approach is more effective. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pregnancy health management.

What prior data suggests that this mHealth intervention is safe for pregnant women?

Research shows that lifestyle changes during pregnancy, like those in this study, are generally easy for participants to manage. Previous studies have found that these changes help women gain a healthy amount of weight during pregnancy, with no major reports of harm or serious side effects.

For example, one study found that lifestyle changes helped women manage their weight better without significant negative effects. Another analysis showed that these programs were linked to healthier weight outcomes for both mothers and babies.

Overall, the safety of such lifestyle changes appears positive, with studies highlighting their benefits and minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this lifestyle intervention for managing pregnancy weight gain because it combines personalized support and technology in a way that current options do not. Unlike traditional methods that rely heavily on in-person consultations, this approach uses a mix of telephone counseling with dieticians trained in motivational interviewing, alongside tech-based tools like automated texts and weekly emails. The intervention is tailored to each individual's progress, offering personalized text messages and one-on-one coaching if needed, which could make it more accessible and adaptable to women's busy lives during pregnancy.

What evidence suggests that this lifestyle intervention is effective for managing gestational weight gain?

Research has shown that lifestyle changes can help control weight gain during pregnancy. In this trial, participants in the Lifestyle Intervention arm will receive support through a mobile health tool, personalized messages, and coaching to manage their weight gain. A study with 17,596 participants found that combining healthy eating and exercise reduced weight gain by about 0.82 kg on average. Another analysis identified certain aspects of these lifestyle changes as particularly effective. This suggests that the approach used in this trial could help women manage their weight gain during pregnancy. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for overweight or obese pregnant women with a pre-pregnancy BMI of 25 to <40, who are patients at Kaiser Permanente in San Francisco or Oakland. Participants must have access to a smartphone and Wi-Fi, understand English, and not be on bed rest or planning to move during the study.

Inclusion Criteria

Provides informed consent to participate.

Women receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians consent to participate

Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record);

Exclusion Criteria

Inability to speak, read, or understand English

I am 15 weeks pregnant.

I am currently on bed rest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mobile health intervention to achieve appropriate gestational weight gain, including personalized text messages and 1:1 telephone coaching sessions

Up to 9 months

1 telephone counseling session, ongoing virtual support

Follow-up

Maternal outcomes are assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Intervention

Trial Overview The trial tests a mobile health intervention aimed at helping participants maintain pregnancy weight gain within recommended limits. It includes an mHealth tool, personalized texts, and telephone coaching sessions for those not meeting guidelines—compared against usual medical care.

How Is the Trial Designed?

Group I: Lifestyle Intervention Experimental Treatment 1 Intervention

The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines.

Group II: Usual Care - Control Active Control 1 Intervention

Usual Medical Care

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552448/

Participant characteristics in the effectiveness of lifestyle ... Combined diet and physical activity interventions in 53 studies (n = 17,596) significantly reduced GWG (MD −0.82 kg; 95% CI: −1.45, −0.18).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06370533

Healthy Gestational Weight Gain Programme This study aims to evaluate the efficacy of a multi-component lifestyle interventions during pregnancy on promoting appropriate gestational weight gain, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2806186

Key Components of Antenatal Lifestyle Interventions to ... This meta-analysis investigates the association of components of antenatal lifestyle interventions with optimized gestational weight gain ...

4. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-025-01182-w

a systematic review and dose-response meta-analysis of data ... Effects of lifestyle intervention on dietary intake, physical activity level, and gestational weight gain in pregnant women with different ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523016465

Effect of lifestyle intervention on dietary habits, physical ... Conclusions: Both lifestyle interventions improved the nutritional habits of obese women during pregnancy. Neither PA nor GWG was affected. Previous article ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11478446/

Lifestyle Intervention to Promote an Adequate Gestational ... In a cohort of obese women, the exposure to an LI was associated with more adequate GWG, reduced insufficient weight gain, and a decreased risk of SGA infants.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522031550

The Behavioral Wellness in Pregnancy study Adequate weight gain during pregnancy is important to both maternal and fetal outcomes. To date, randomized controlled trials have not been effective at ...