Healthy Eating & Active Living Program for Obesity

(HEALTH D&I Trial)

No longer recruiting at 1 trial location

Overseen By Cindy D Schwarz, MPH, MS, RD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, Non-English/Spanish, Walking inability

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 25

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a home-based program designed to prevent weight gain and promote weight loss for individuals with obesity. The program focuses on teaching healthy eating and active living habits through home visits, which may reduce risks for chronic diseases like heart disease and diabetes. It compares the new program, called Healthy Eating & Active Living Taught at Home, with usual care practices to determine which is more effective. This trial is ideal for individuals who are overweight or obese, speak English or Spanish, and participate in the Parents as Teachers program. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the "Healthy Eating & Active Living Taught at Home" program, based on a lifestyle change strategy from the Diabetes Prevention Program, is promising for weight loss and maintenance. Previous studies have found that participants, including overweight mothers, lost significant weight without major side effects.

The program teaches healthy eating and active living habits at home, often through home visits. These habits are practical and easy to integrate into daily life, reducing potential risks.

By focusing on lifestyle changes instead of medication, the program generally presents fewer safety concerns. Participants typically report positive experiences, emphasizing the program's focus on real-world, lasting health improvements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Healthy Eating & Active Living Program for Obesity is unique because it integrates lifestyle change strategies directly into participants' home lives through personalized visits. Unlike typical obesity treatments that often involve medication or structured programs at clinics, this approach empowers individuals by embedding healthy habits as part of their everyday routine. Researchers are excited about this method because it combines evidence-based strategies with the supportive environment of home visits, which can potentially lead to sustainable weight management and improved overall health outcomes.

What evidence suggests that the Healthy Eating & Active Living Program is effective for obesity?

Research has shown that the Healthy Eating & Active Living Taught at Home (HEALTH) program, which participants in this trial may receive, helps people lose weight and maintain it. Studies have found that lifestyle changes from this program improve weight control. The HEALTH program uses proven methods to guide participants in making healthier choices, teaching these methods during home visits to integrate them into everyday life. Although some studies reported mixed results, the overall evidence suggests it can positively affect obesity and related health issues like heart disease and diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Rachel G Tabak, PhD, RD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-45 who are overweight or obese, with a BMI of 25-45 kg/m2. They must be English or Spanish speakers participating in the Parents as Teachers program at a study site and willing to do so for two years. Pregnant individuals or those planning pregnancy within the next 24 months cannot join.

Inclusion Criteria

able to give informed consent for participation

Provide informed consent

Deliver PAT at a site participating in the study

Exclusion Criteria

I cannot speak English or Spanish.

I cannot participate in a walking program.

currently pregnant or planning to become pregnant in the next 24 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Parent educators receive training in the HEALTH curriculum to implement lifestyle change strategies

2-4 years

Ongoing training sessions

Intervention

Participants receive usual care PAT plus evidence-based lifestyle change strategies during home visits

24 months

Up to 25 home visits per year

Follow-up

Participants are monitored for changes in weight and other health outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Eating & Active Living Taught at Home
• Usual Care

Trial Overview The HEALTH intervention, which aims to prevent weight gain and promote weight loss through home-based education on healthy eating and active living, is being tested against usual care. The study also examines how well this program works when taught by trained instructors in real-world settings.

How Is the Trial Designed?

Group I: Healthy Eating & Active Living Taught at Home Experimental Treatment 1 Intervention

PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy). Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.

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+

Published Research Related to This Trial

In a study involving 116 patients over two years, educational measures and regular follow-ups significantly contributed to weight loss, with 5.1% achieving a weight reduction of at least 10%.

Patients who voluntarily discharged themselves showed the largest decrease in BMI (12.8), highlighting the importance of personal motivation in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. Díaz Gómez, J., Armero Fuster, M., Calvo Viñuela, I., et al.[2013]

The HOP'N Home project successfully engaged parents in obesity prevention practices by teaching children to ask for healthful changes at home, with 100% of parents adopting the program and over 90% implementing changes.

The percentage of overweight or obese children decreased from 50% at the start of the program to 29% post-intervention, indicating a positive trend in obesity prevention, although the results were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent adoption and implementation of obesity prevention practices through building children's asking skills at family child care homes. Walch, TJ., Rosenkranz, RR., Schenkelberg, MA., et al.[2020]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

The modified EFNEP curriculum, which included videos and interactive discussions, led to a significant decrease in BMI for the intervention group, highlighting its effectiveness in obesity prevention among participants.

Both the intervention and control groups showed improvements in dietary habits and psychosocial factors, but only the intervention group experienced a notable reduction in BMI, suggesting that the enhanced curriculum may be particularly beneficial for managing weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating healthful home food environments: results of a study with participants in the expanded food and nutrition education program. Cullen, KW., Lara Smalling, A., Thompson, D., et al.[2021]

A randomized control trial involving 60 obese students showed that a self-empowerment-based coaching program significantly reduced total body fat and improved healthy behavior habits compared to a control group.

The intervention group also reported greater improvements in satisfaction related to hobbies, exercise, sleep, and spiritual well-being, indicating a holistic benefit of the coaching approach in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. Dewi, DK., Sekartini, R., Sunardi, D., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03758638

Healthy Eating and Active Living Taught at Home (HEALTH ... This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6934432/

Weight gain prevention content delivered to mothers: Lessons ... This is a secondary analysis from the Healthy Eating and Active Living Taught at Home (HEALTH) randomized trial. HEALTH is a weight gain prevention intervention ...

3. prcstl.wustl.edu prcstl.wustl.edu/does-the-neighborhood-built-environment-moderate-the-effectiveness-of-a-weight-loss-intervention-for-mothers-with-overweight-or-obesity-findings-from-the-healthy-eating-and-active-living-taught-at-ho/

Does the neighborhood built environment moderate ... Lifestyle interventions such as the Healthy Eating and Active Living Taught at Home (HEALTH) study have been effective for weight loss; however ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404618307875

The Impact of a Healthy Weight Intervention Embedded in ... The reviewed studies reported almost no significant effects on child weight-based outcomes. Only two studies (one was an underpowered pilot study) resulted in ...

5. clinicaltrials.gov clinicaltrials.gov/show/NCT01567033

Healthy Eating and Active Living Taught at Home (HEALTH) The purpose of this research study is to evaluate two different Parents as Teachers curriculums taught by parent educators, during home visits.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01567033

Healthy Eating and Active Living Taught at Home (HEALTH) The primary aim is to test Healthy Eating & Active Living Taught at Home (HEALTH), which adapts and integrates the Diabetes Prevention Program lifestyle ...

7. obesityprevention.wustl.edu obesityprevention.wustl.edu/items/healthy-eating-and-active-living-at-home-health/

Healthy Eating and Active Living Taught at Home (HEALTH) Diabetes intervention plus home visits boosts weight loss in mothers with overweight, obesity. By Melissa J. Webb on April 11, 2018. Diabetes intervention ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8313625/

A practical approach to obesity prevention: Healthy home ... Nurse practitioners can encourage families to participate in healthy habits by addressing areas of growth for obesity prevention within the home.

9. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-022-01368-z

Does the neighborhood built environment moderate the ... This study examined whether characteristics of the neighborhood built environment modified effectiveness of the HEALTH study on weight loss.