Health Interventions for Obesity During Pregnancy

(CHIME Trial)

Overseen By Jennifer Woo Baidal Associate Professor, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Underweight, Gastrointestinal, Psychiatric, others

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

Compensation: Varies

Number of Visits: 5

795 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum. The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum. Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group. Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention. Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of: * Questionnaires * Dietary recalls * In-depth interviews * Anthropometric measurements * Collection of blood via finger stick or blood panel

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Community-Based, Self-Management for obesity during pregnancy?

Research on weight management interventions for pregnant women with obesity suggests that these programs can help reduce body mass index (BMI) 12 months after giving birth, indicating potential effectiveness in managing weight during and after pregnancy. ^{1 2 3 4 5}

Is the community-based, self-management intervention for obesity during pregnancy safe for humans?

The research on community-based interventions for managing obesity during pregnancy, such as the 'Healthy Eating and Lifestyle in Pregnancy (HELP)' trial, suggests that these programs are generally safe for pregnant women. They focus on healthy eating and lifestyle changes, which are typically safe and beneficial for both mother and baby. ^{3 6 7 8 9}

How is the Community-Based, Self-Management treatment for obesity during pregnancy different from other treatments?

This treatment is unique because it focuses on community engagement and self-management, encouraging pregnant women to participate in local initiatives like community gardens and physical activity programs, which are tailored to their needs and preferences. Unlike traditional medical treatments, it emphasizes collective community action and support to promote healthy behaviors during pregnancy. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for pregnant individuals dealing with obesity or chronic diseases like diabetes. They should be interested in managing their weight during and after pregnancy. Participants will need to commit from early pregnancy until 12 months postpartum, completing questionnaires, dietary recalls, interviews, measurements, and blood tests.

Inclusion Criteria

I am 18 years old or older.

Plans to continue receiving antenatal care at the recruitment site/network

Maternal characteristics include at least one of the following: Self identifies as Black/African American, Self identifies as Hispanic/Latino/a/e/x, Insured by Medicaid, Maternal ability to speak English or Spanish, Completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization)

Exclusion Criteria

Underweight (BMI <18 kg/m2) at pre-pregnancy period

Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)

Multiple gestations

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in one of the study interventions from early pregnancy until 12 months postpartum, including nutrition and physical activity counseling

12 months

5 visits (in-person)

Follow-up

Participants are monitored for maternal postpartum weight retention and other health outcomes

4 weeks

Treatment Details

Interventions

• Community-Based
• Self-Management

Trial Overview The CHIME trial compares three approaches: usual care versus two multi-level interventions aimed at reducing maternal weight retention a year after giving birth. One intervention focuses on self-management while the other is community-based; both include nutrition and activity counseling.

Participant Groups

Group I: Self-Management Experimental Treatment 1 Intervention

A self-management intervention through direct provision of social needs supports (grocery, physical activity, and transportation support) with self-directed behavior change tools and usual care.

Group II: Community-Based Experimental Treatment 1 Intervention

A community-based intervention for active social needs referrals assistance with health coaching and active lifestyle intervention and usual care.

Group III: Usual Care Active Control 1 Intervention

Patients randomized to the usual care control group will not receive the study interventions. Instead, these patients will receive usual care which includes social needs screening in the clinical setting, targeted community service and program referrals, clinical decision support tools for social needs support in the electronic health record, and routine clinical care with provider-based lifestyle counseling.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

A review of randomized controlled trials found that dietary and lifestyle interventions during pregnancy for overweight or obese women did not show significant benefits compared to standard care for maternal or infant health outcomes.

Only two trials were identified, indicating a lack of sufficient research on the effectiveness and safety of these interventions, highlighting the need for more robust studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. Dodd, JM., Crowther, CA., Robinson, JS.[2022]

The IMPACT DIABETES Bump2Baby study is testing a mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) for women at risk of gestational diabetes, aiming to improve health behaviors during pregnancy and postpartum through personalized coaching and support.

This multicenter randomized controlled trial will involve 800 women across four countries and is designed to evaluate both the feasibility and effectiveness of the intervention, with results expected in 2024, marking it as the first hybrid effectiveness-implementation study of its kind in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study. O'Reilly, SL., Laws, R., Maindal, HT., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum. [2023]

2. Scotland pubmed.ncbi.nlm.nih.gov

Physical activity in pregnant women with Class III obesity: A qualitative exploration of attitudes and behaviours. [2022]

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

Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy. [2022]

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

Barriers to weight management in pregnant mothers with obesity: a qualitative study on mothers with low socioeconomic background. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Maternal obesity support services: a qualitative study of the perspectives of women and midwives. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Diet, Physical Activity and Gestational Weight Gain Patterns among Pregnant Women Living with Obesity in the North East of England: The GLOWING Pilot Trial. [2022]

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

Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Weight management in Pregnancy: Participants' experiences of 'Healthy Eating and Lifestyle in Pregnancy (HELP)', a maternity care intervention for obese pregnant women. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The design of a community lifestyle programme to improve the physical and psychological well-being of pregnant women with a BMI of 30 kg/m2 or more. [2021]

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

Community Coalitions for Change and the Policy, Systems, and Environment Model: A Community-Based Participatory Approach to Addressing Obesity in Rural Tennessee. [2020]

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

Infant Obesity Prevention Programs for Underrepresented Mothers in a Home Visiting Program: A Qualitative and Community-Engaged Needs Assessment. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Community-based service provision for the prevention and management of maternal obesity in the North East of England: a qualitative study. [2022]

14. Australia pubmed.ncbi.nlm.nih.gov

Attendance rates and characteristics of women with obesity referred to the dietitian for individual weight management advice during pregnancy. [2021]