Health Coaching Strategies for Preventing Postpartum Diabetes

(STRIVE Trial)

Overseen By Kirsten Dorans, ScD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Diabetes, Pregnancy, Moving, others

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

Compensation: Varies

Number of Visits: 25

Duration: 12 months

722 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help new mothers prevent diabetes after childbirth. One group will attend 24 in-person sessions with a health coach, focusing on healthy eating and exercise, as part of the GLB (Diabetes Prevention Program). The other group will participate in 12 in-person sessions and receive additional support through technology, such as apps and online resources, also within the GLB framework. Women who gave birth in the past year and have either obesity or a history of gestational diabetes, but no current diabetes, might be suitable candidates. Participants need access to a smartphone and must be willing to attend sessions at WIC clinics. As an unphased trial, this study provides a unique opportunity to contribute to research that could benefit future mothers.

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's best to discuss this with the study coordinator or your healthcare provider.

What prior data suggests that these health coaching strategies are safe for postpartum women?

Research shows that the Group Lifestyle Balance (GLB) program, used in both health coaching methods, is safe for participants. The in-person health coaching relies on the National Diabetes Prevention Program, which over 300,000 people have used without major safety issues. This program emphasizes lifestyle changes, such as improving diet and exercise, which are generally manageable and rarely cause serious side effects.

The technology-assisted version of the program incorporates digital tools for self-monitoring and communication with coaches. Studies indicate that these digital health tools effectively support diabetes prevention without adding significant safety risks. Both methods focus on behavior changes and monitoring, which are safe and have a proven track record in reducing the risk of diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these health coaching strategies for preventing postpartum diabetes because they offer a personalized approach that combines behavioral intervention with either in-person or tech-assisted support. Unlike traditional methods, which often rely on general lifestyle advice, the in-person strategy provides 24 sessions of customized coaching, focusing heavily on diet, physical activity, and self-monitoring. Meanwhile, the technology-assisted strategy adds a modern twist by incorporating digital tools for self-monitoring and allowing for flexible, asynchronous interaction with both coaches and peers. These approaches aim to make lifestyle changes more accessible and sustainable for new moms, potentially leading to better prevention outcomes.

What evidence suggests that this trial's treatments could be effective for preventing postpartum diabetes?

Research has shown that the Diabetes Prevention Program (DPP), which forms the basis of the Group Lifestyle Balance (GLB) program, effectively improves health. Studies have found that participants in similar programs often lose about 4% of their body weight, aiding in diabetes risk management. For new mothers, these programs can reduce the likelihood of developing type 2 diabetes by promoting healthier eating and exercise habits.

In this trial, participants will follow one of two health coaching strategies. The in-person health coach strategy delivers 24 health coaching sessions over a year. Alternatively, the technology-assisted health coach strategy includes 12 in-person sessions, supplemented with technology support for self-monitoring and coach interaction. Early evidence suggests that technology-assisted delivery can enhance diabetes prevention efforts by simplifying progress tracking and maintaining contact with health coaches. Both approaches use proven strategies to help reduce diabetes risk in new mothers. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for postpartum women who are 18 or older, gave birth within the last year, and have obesity or a history of gestational diabetes. They should not currently have diabetes (except gestational), plan to become pregnant soon, or move away in the next year. Access to a smartphone is required.

Inclusion Criteria

Gave birth in the past 6 weeks to 12 months

Not currently pregnant or planning to become pregnant in the next 6 months

I do not have diabetes, except for gestational diabetes if applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 24 in-person health coaching sessions or 12 in-person sessions with technology support over one year

12 months

24 visits (in-person) or 12 visits (in-person) with additional virtual support

Follow-up

Participants are monitored for sustainability of the implementation strategies 6 months after the intervention

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• In-person health coach delivery of the GLB
• Technology-assisted health coach delivery of the GLB

Trial Overview The STRIVE study compares two ways of delivering a Diabetes Prevention Program: one with an in-person health coach at WIC clinics and another combining in-person sessions with technology support like apps.

How Is the Trial Designed?

Group I: In-person health coach strategy Active Control 1 Intervention

Delivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.

Group II: Multifaceted technology-assisted health coach implementation strategy Active Control 1 Intervention

Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.

In-person health coach delivery of the GLB is already approved in United States for the following indications:

Approved in United States as National Diabetes Prevention Program for:

• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The STAR MAMA trial is testing a 20-week postpartum program based on the Diabetes Prevention Program (DPP) to help low-income minority women with prior gestational diabetes or high BMIs reduce their risk of developing diabetes, targeting 180 women in San Francisco and Sonoma Counties.

Preliminary results show high engagement among participants, with 86% responding to health coaching calls, indicating that community-based adaptations of the DPP can effectively support postpartum women in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking High Risk Postpartum Women with a Technology Enabled Health Coaching Program to Reduce Diabetes Risk and Improve Wellbeing: Program Description, Case Studies, and Recommendations for Community Health Coaching Programs. Athavale, P., Thomas, M., Delgadillo-Duenas, AT., et al.[2021]

Technology-assisted diabetes prevention programs (DPP), including mobile text messaging, apps, and telehealth, have shown potential for clinically meaningful weight loss and cost-effectiveness in preventing type 2 diabetes.

These interventions can be widely distributed and sustained, making them accessible options for individuals at risk for diabetes, although further research is needed to identify the most effective combination of features for these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Technology-Assisted Interventions for Diabetes Prevention. Grock, S., Ku, JH., Kim, J., et al.[2022]

The modified Diabetes Prevention Program (DPP) lifestyle intervention, implemented as a 12-session Group Lifestyle Balance program, effectively reduced weight, waist circumference, and BMI in 93 nondiabetic participants over a 3-month period, with an average weight loss of 7.4 pounds (3.5% relative loss).

Participants in the program also showed significant improvements in cardiovascular risk factors, including reductions in total cholesterol and blood pressure, with over 80% of those achieving a 7% weight loss maintaining it at 6 months post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Kramer, MK., Kriska, AM., Venditti, EM., et al.[2022]

Health coaching can be successfully integrated into primary care clinics in Eastern Ontario, Canada, providing six months of personalized support for patients at risk for or diagnosed with diabetes.

Key factors for successful implementation include physician support, clear understanding of the health coach's role, effective team communication, and consideration of organizational structure and patient readiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching in primary care: a feasibility model for diabetes care. Liddy, C., Johnston, S., Nash, K., et al.[2021]

The National Diabetes Prevention Program (National DPP) is effective in reducing diabetes risk among individuals with prediabetes, but its implementation varies significantly across clinic, community-based, and digital settings, highlighting the need for tailored approaches.

Recruitment and retention of participants are challenging across all settings, requiring significant time and effort, while effective data reporting is facilitated by advanced data management systems and experienced staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current practices, facilitators, and barriers experienced by program providers implementing the National Diabetes Prevention Program in Los Angeles County. Green, G., DeFosset, AR., Sivashanmugam, M., et al.[2021]

The Kaiser Permanente Northern California Division of Research is evaluating two diabetes prevention programs: a telephonic health-coaching program focused on healthy eating and weight loss, and a postpartum glucose screening program for women with gestational diabetes, highlighting the importance of targeted interventions for high-risk populations.

These studies aim to identify effective strategies for diabetes prevention, which can inform healthcare systems and policymakers on how to better support chronic illness prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-plan and employer-based wellness programs to reduce diabetes risk: The Kaiser Permanente Northern California NEXT-D Study. Schmittdiel, JA., Brown, SD., Neugebauer, R., et al.[2022]

The adapted Diabetes Prevention Program (DPP) led to significant weight loss and improvements in A1C levels among incarcerated individuals, with the intervention group losing an average of 12 pounds compared to 5 pounds in the control group after 6 months.

Both the intervention and control groups showed significant decreases in BMI and A1C levels after 12 months, suggesting that even a delayed start to the program can yield beneficial cardiometabolic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention in Prison: The Diabetes Prevention Program in a Correctional Setting. Fine, A., Gallaway, MS., Dukate, A.[2022]

A case study of a 32-year-old woman who gained excess weight during pregnancy showed that a 6-month personalized health planning with integrative health coaching (PHP-IHC) intervention improved her physical activity, energy expenditure, and confidence in health-promoting behaviors.

Although she did not reach her target weight by the end of the coaching sessions, follow-up 8 months later revealed she achieved her goal, suggesting that PHP-IHC can effectively support postpartum weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized health planning with integrative health coaching to reduce obesity risk among women gaining excess weight during pregnancy. Yang, NY., Wroth, S., Parham, C., et al.[2022]

The Group Lifestyle Balance program (GLB), adapted from the Diabetes Prevention Program (DPP), was evaluated in a pilot project using a DVD format with remote support.

Results indicate that the GLB-DVD with remote support could be an effective alternative method for delivering lifestyle intervention programs, potentially improving accessibility for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. Kramer, MK., Kriska, AM., Venditti, EM., et al.[2022]

A qualitative study involving 20 participants from the NHS Diabetes Prevention Program revealed significant variation in understanding self-regulatory behavior change techniques (BCTs), particularly in techniques like action planning and problem solving, which many participants found challenging without additional support.

Participants generally understood and valued BCTs focused on outcomes, such as self-monitoring behaviors and goal setting, indicating that while some techniques are effective, others may require more structured guidance to enhance comprehension and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How is the Behavior Change Technique Content of the NHS Diabetes Prevention Program Understood by Participants? A Qualitative Study of Fidelity, With a Focus on Receipt. Miles, LM., Hawkes, RE., French, DP.[2022]

The Group Lifestyle Balance (GLB) program, based on the Diabetes Prevention Program, effectively reduced the prevalence of prediabetes by 2.0%, obesity by 8.7%, and metabolic syndrome by 6.8% among participants who completed the 12-week intervention.

Despite a high initial attendance of 704 patients, only 52% completed the program, with significant dropouts occurring within the first four weeks, particularly among active duty military members, highlighting the need for strategies to improve retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Group Lifestyle Balance Program in a Military Setting: An Investment Worth Expanding. Wardian, JL., True, MW., Sauerwein, TJ., et al.[2019]

Women with a history of gestational diabetes are at a higher risk of developing type 2 diabetes, highlighting the importance of early intervention.

The article reviews various prevention strategies, including lifestyle changes, medications, and breastfeeding, aimed at reducing the risk of type 2 diabetes in these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoiding the slippery slope: preventing the development of diabetes in women with a history of gestational diabetes. Feig, DS.[2012]

Women with a history of gestational diabetes are at a high risk for developing type 2 diabetes, and should be screened during and after the postpartum period using specific glucose cutoffs to diagnose diabetes or pre-diabetes.

Lifestyle interventions focusing on reducing caloric intake and increasing physical activity are recommended as the first-line strategy to prevent or delay diabetes onset, especially for women with additional risk factors like obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attenuating type 2 diabetes with postpartum interventions following gestational diabetes mellitus. Wasalathanthri, S.[2020]

Citations

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Effectiveness of the National Diabetes Prevention Program ... Outcomes have been well-documented for most participants; e.g., ~4% weight loss overall; ~2% weight loss for younger adults, women, racial and ethnic minority ...

2. tulane.trialstoday.org tulane.trialstoday.org/trial/NCT06116149

Tulane Research - Clinical Translational Unit The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person ...

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Evidence Research studies and evaluations have repeatedly shown that interventions such as the National DPP lifestyle change program improve health outcomes.

4. icer.org icer.org/wp-content/uploads/2020/10/CTAF_DPP_Final_Evidence_Report_072516.pdf

Diabetes Prevention Programs: Effectiveness and Value Among the digital with human coach programs, only the Omada study reported results, but the change in HbA1c (-0.4% at 12 months) was the largest reported of any ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725002839

Co-Designing a postpartum diabetes prevention program ... Evidence indicates that postpartum diabetes prevention programs can reduce the incidence of T2DM in postpartum women after GDM through promoting physical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37928892/

Delivering the National Diabetes Prevention Program We assessed outcomes using data from 333,715 participants who started the 12-month program between January 1, 2012, and December 31, 2018. The ...

7. cdc.gov cdc.gov/diabetes-prevention/php/program-provider/staffing-and-training.html

Staffing and Training for The National Diabetes Prevention ... Find resources and training to help your staff successfully deliver the National Diabetes Prevention Program (National DPP) lifestyle change program.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5088315/

Linking High Risk Postpartum Women with a Technology ... Results from the Diabetes Prevention Program (DPP) suggest that the long-term risk for diabetes postpartum can be reduced through behavior change [12–14].

9. professional.diabetes.org professional.diabetes.org/clinical-support/nationaldpp

National DPP Lifestyle Change Program for At-Risk Adults The National Diabetes Prevention Program (National DPP) lifestyle change program is proven to prevent or delay the onset of type 2 diabetes in adults by 58%.

10. diabetesjournals.org diabetesjournals.org/spectrum/article/31/4/324/32429/Linking-Postpartum-and-Parenting-Women-With-a

Linking Postpartum and Parenting Women With a National ... In the United States, the Diabetes Prevention Program research study resulted in a 58% reduction in type 2 diabetes with intensive lifestyle ...