Healthy Eating & Active Living Program for Obesity

(HEALTH D&I Trial)

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

624 Participants Needed

Trial Summary

What is the purpose of this trial?

This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH 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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Healthy Eating & Active Living Taught at Home treatment for obesity?

Research shows that educational interventions focusing on healthy eating and regular follow-ups can help people with obesity achieve balanced eating habits and weight loss. Additionally, programs that include behavior modification, nutrition education, and physical activity have been effective in helping children lose weight and improve their health. ^{1 2 3 4 5}

Is the Healthy Eating & Active Living Program for Obesity safe for humans?

The available research on similar programs, like school-based nutrition and activity initiatives, suggests they are generally safe for children, as they focus on education and behavior changes without harmful side effects. ^{4 6 7 8 9}

How does the Healthy Eating & Active Living Taught at Home treatment for obesity differ from other treatments?

The Healthy Eating & Active Living Taught at Home treatment is unique because it focuses on teaching healthy lifestyle habits directly in the home environment, which can lead to more sustainable changes in eating and physical activity. This approach contrasts with other treatments that may rely on external programs or quick-fix solutions, emphasizing long-term behavior change and practical application in daily life. ^{10 11 12 13 14}

Research Team

Rachel G Tabak, PhD, RD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

I am between 18 and 45 years old.

Provide informed consent

Exclusion Criteria

I cannot speak English or Spanish.

I cannot participate in a walking program.

I am 18 years old or older.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Results of educational intervention in obese patients]. [2013]

2. India pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. [2023]

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

Improving diet and physical activity to reduce population prevalence of overweight and obesity: an overview of current evidence. [2022]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of weight reduction on eating behaviors and quality of life: Influence of the obesity degree. [2021]

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

Creating healthful home food environments: results of a study with participants in the expanded food and nutrition education program. [2021]

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

Active generations: an intergenerational approach to preventing childhood obesity. [2016]

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

The Healthy Weight Collaborative: using learning collaboratives to enhance community-based prevention initiatives addressing childhood obesity. [2013]

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

The Health and Obesity: Prevention and Education (HOPE) Curriculum Project--curriculum development. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Clinical practice and variation in care for childhood obesity at seven clinics in California. [2018]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

Use of cognitive-behavioral approach to overweight and obesity therapy in STOB activities. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Parent adoption and implementation of obesity prevention practices through building children's asking skills at family child care homes. [2020]

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

LIFESTEPS: Weight Management Program. [2008]

14. India pubmed.ncbi.nlm.nih.gov

Noni-based nutritional supplementation and exercise interventions influence body composition. [2021]