HEALTH-P2 Intervention for Preventing Obesity During and After Pregnancy

(HEALTH-P2 Trial)

Overseen By Cindy Schwarz, MPH,MS,RD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy plans, Walking inability

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

784 Participants Needed

Trial Summary

What is the purpose of this trial?

This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the HEALTH-P2 treatment for preventing obesity during and after pregnancy?

Research shows that interventions combining diet and physical activity are more effective for weight loss in postpartum women. Additionally, health coaching has been shown to help women return to pre-pregnancy weight after gaining excess weight during pregnancy. ^{1 2 3 4 5}

Is the HEALTH-P2 Intervention safe for preventing obesity during and after pregnancy?

The available research on health coaching interventions, similar to HEALTH-P2, suggests they are generally safe for use during and after pregnancy. These interventions focus on improving diet, physical activity, and weight management, which are typically safe and beneficial for most people. ^{2 3 6 7 8}

How is the HEALTH-P2 treatment different from other treatments for preventing obesity during and after pregnancy?

The HEALTH-P2 treatment is unique because it focuses on both the pregnancy and postpartum periods, using a comprehensive approach that may include personalized health coaching and lifestyle changes. Unlike many other interventions that target only one stage, this treatment aims to provide continuous support throughout the entire perinatal period. ^{2 3 6 8 9}

Research Team

Rachel G Tabak, PhD, RD

Principal Investigator

Washington University School of Medicine

Debra Haire-Joshu, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for pregnant women aged 18-45 who are overweight or obese, speak English or Spanish, and are willing to participate in a program called Parents as Teachers (PAT) until their baby turns one. They must not plan another pregnancy before their current baby's first birthday and should be able to engage in walking.

Inclusion Criteria

Deliver PAT at a site participating in the study

overweight or obese (BMI over 25 kg/m2) before becoming pregnant

I speak English or Spanish.

Exclusion Criteria

I am 18 years old or older.

I cannot participate in a walking program.

planning to become pregnant again before their baby turns 1

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the HEALTH-P2 intervention through trained parent educators as part of routine practice

12 months

Regular visits as part of routine practice

Follow-up

Participants are monitored for weight change and other health outcomes postpartum

12 months

Implementation Evaluation

Evaluation of implementation outcomes such as fidelity, acceptability, and feasibility

2-4 years

Treatment Details

Interventions

• HEALTH-P2
• Usual Care

Trial Overview The study tests the HEALTH-P2 intervention aimed at preventing excessive weight gain during pregnancy through the first year postpartum. It compares this with usual care and assesses how well it works when applied by PAT, focusing on outcomes like obesity prevention and chronic disease impact.

Participant Groups

Group I: HEALTH-P2 Experimental Treatment 1 Intervention

Along with PAT National Center, parent educators affiliated with PAT sites in HEALTH-P2; with be trained to use the HEALTH-P2 training curriculum (implementation strategy).

Group II: Usual Care Active Control 1 Intervention

Participants at usual care PAT sites will receive PAT as usual.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

This systematic review analyzed 38 studies on interventions aimed at preventing obesity in high-risk infants, revealing that nearly all effective interventions focused on improving infant and maternal nutrition.

Nine interventions showed some success in improving weight trajectories, particularly those that involved longer engagement with parents and support from health professionals, although the positive effects often decreased over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing obesity in the first 1000 days in high risk infants: Systematic review. Rossiter, C., Cheng, H., Appleton, J., et al.[2021]

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 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]

A systematic review of 46 studies involving 1,892 postpartum women found that lifestyle interventions incorporating self-monitoring led to significantly greater weight loss compared to those without self-monitoring, with an average loss of 4.61 kg versus 1.34 kg.

Combining diet and physical activity was more effective for weight loss than physical activity alone, resulting in an average weight loss of 3.24 kg compared to 1.63 kg, highlighting the importance of a comprehensive approach to postpartum weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective strategies for weight loss in post-partum women: a systematic review and meta-analysis. Lim, S., O'Reilly, S., Behrens, H., et al.[2018]

A low-intensity self-management intervention during pregnancy significantly reduced postpartum weight retention in women at risk of gestational diabetes, with a notable difference of 1.45 kg less weight gain compared to the control group by 6 weeks postpartum.

The intervention was particularly effective for overweight women, and factors such as higher baseline BMI and age were linked to lower weight retention, suggesting that targeted strategies could enhance antenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limiting postpartum weight retention through early antenatal intervention: the HeLP-her randomised controlled trial. Harrison, CL., Lombard, CB., Teede, HJ.[2022]

The mums OnLiNE intervention, which included an online calorie tracking program and dietitian support, led to a significant reduction in waist circumference among first-time mothers, decreasing by 6.4 cm compared to control groups.

While the intervention showed promise in waist circumference reduction, it did not result in significant changes in postpartum weight retention, diet, physical activity, or sedentary behavior, indicating the need for further research on effective strategies for weight management in postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot intervention to reduce postpartum weight retention and central adiposity in first-time mothers: results from the mums OnLiNE (Online, Lifestyle, Nutrition & Exercise) study. van der Pligt, P., Ball, K., Hesketh, KD., et al.[2019]

A study of 39 women living with obesity showed that their postnatal diet and physical activity levels were below national guidelines, particularly in fruit and vegetable intake and overall activity intensity.

Women who gained excessive weight during pregnancy had less postnatal weight loss compared to those who did not, indicating that interventions focusing on gestational weight gain could be crucial for improving outcomes in future pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal Obesity and Patterns in Postnatal Diet, Physical Activity and Weight among a Highly Deprived Population in the UK: The GLOWING Pilot Trial. Heslehurst, N., Cullen, E., Flynn, AC., et al.[2023]

The HIPP Study will evaluate the effectiveness of a specialized health coaching intervention in preventing excessive weight gain during pregnancy and postpartum weight retention, involving 220 women with a BMI over 18.5.

The study aims to assess not only weight management outcomes but also psychological factors like motivation and body dissatisfaction, providing insights into how health coaching can support women during and after pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study. Skouteris, H., McCabe, M., Milgrom, J., et al.[2021]

Lifestyle interventions that include both dietary changes and physical activity can effectively reduce postpartum weight retention, as shown in 7 out of 11 studies reviewed, primarily randomized controlled trials.

While postpartum weight loss is achievable and important for preventing obesity in mothers, the best methods for delivering these interventions and their optimal duration remain uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of lifestyle interventions to limit postpartum weight retention: implications for future opportunities to prevent maternal overweight and obesity following childbirth. van der Pligt, P., Willcox, J., Hesketh, KD., et al.[2022]

References

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

Addressing obesity in the first 1000 days in high risk infants: Systematic review. [2021]

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

Personalized health planning with integrative health coaching to reduce obesity risk among women gaining excess weight during pregnancy. [2022]

3. 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]

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

Effective strategies for weight loss in post-partum women: a systematic review and meta-analysis. [2018]

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

Limiting postpartum weight retention through early antenatal intervention: the HeLP-her randomised controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A pilot intervention to reduce postpartum weight retention and central adiposity in first-time mothers: results from the mums OnLiNE (Online, Lifestyle, Nutrition & Exercise) study. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Maternal Obesity and Patterns in Postnatal Diet, Physical Activity and Weight among a Highly Deprived Population in the UK: The GLOWING Pilot Trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study. [2021]

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

Systematic review of lifestyle interventions to limit postpartum weight retention: implications for future opportunities to prevent maternal overweight and obesity following childbirth. [2022]