HeLP vs Usual Care for Childhood Obesity

Recruiting at 1 trial location

Overseen By Emily J Steen, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Severe depression, Type 2 diabetes, others

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

Compensation: Varies

Number of Visits: 15

Duration: 18 months

554 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment HeLP for childhood obesity?

Family-based behavioral interventions, which are part of the HeLP program, have been shown to be effective in treating childhood obesity. These programs focus on involving the family in making lifestyle changes, such as improving diet and increasing physical activity, which have been proven to help manage obesity in children. ^{1 2 3 4 5}

Is the HeLP program safe for treating childhood obesity?

Family-based behavioral interventions, like the HeLP program, are considered safe for treating childhood obesity and are recommended as a first-line treatment option. ^{1 3 4 5 6}

How is the HeLP treatment for childhood obesity different from other treatments?

The HeLP treatment for childhood obesity is unique because it involves a comprehensive approach that integrates primary care with community resources, focusing on healthy lifestyle promotion and community program referrals, rather than relying solely on clinical interventions or medications. ^{1 3 4 7 8}

Research Team

Matthew A Haemer, MD MPH

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for children aged 2-16 with obesity, referred by their primary care provider. It's designed for Hispanic families and those on Medicaid. The child must be able to walk and talk, not have severe depression or other serious health issues related to obesity. Parents need to speak Spanish or English.

Inclusion Criteria

My BMI is above the 85th percentile, indicating overweight or obesity.

Up to two of my siblings can join the study, regardless of their weight.

My child is between 2 and 16 years old.

Exclusion Criteria

I am a parent not fluent in Spanish or English.

Current participation in a clinically referred obesity treatment program

My child does not have severe obesity-related conditions like Type 2 diabetes, high blood pressure, high cholesterol, or severe sleep apnea.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in either the Healthy Living Program (HeLP) or Recommended Treatment of Obesity in Primary Care (RTOP). HeLP includes 12 family group sessions at community recreation centers, while RTOP involves enhanced primary care visits every 3 months.

18 months

12 sessions (HeLP), every 3 months (RTOP)

Booster Sessions

Participants in the HeLP group receive three group booster sessions occurring every 6 months.

12 months

3 booster sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of BMI, food security, and other health metrics.

6 months

Treatment Details

Interventions

• Recommended Treatment of Obesity in Primary Care
• The Healthy Living Program/La Vida Saludable

Trial Overview The study compares the 'Healthy Living Program' (HeLP), a family-inclusive program held at recreation centers, against enhanced usual care called RTOP in clinics. HeLP includes intensive sessions and follow-ups led by health educators.

Participant Groups

Group I: Community based childhood obesity intervention Experimental Treatment 1 Intervention

A novel family-inclusive childhood obesity treatment program consisting of 12 family group sessions delivered in English and Spanish by health educators at community recreation centers, followed by three group booster sessions occurring every 6 months.

Group II: Primary care based childhood obesity intervention Active Control 1 Intervention

A healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months.

Recommended Treatment of Obesity in Primary Care is already approved in United States for the following indications:

Approved in United States as RTOP for:

• Childhood obesity

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

Findings from Research

Primary care providers can play a crucial role in preventing and treating childhood obesity by integrating efforts in both clinical and community settings, as highlighted by a review of 96 articles published between 2005 and 2012.

The review outlines nine key strategies for providers, including weight monitoring, promoting healthy lifestyles, and advocating for policies, which align with recommendations from major health organizations to enhance the effectiveness of obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the role of primary care in the prevention and treatment of childhood obesity: a review of clinic- and community-based recommendations and interventions. Vine, M., Hargreaves, MB., Briefel, RR., et al.[2023]

In a randomized controlled trial involving 72 obese children, family-based behavioral treatment (FBBT) showed no significant difference in BMI reduction compared to a waiting-list control group, indicating that both groups experienced similar improvements in weight.

The treatment group did report significant reductions in systolic blood pressure and improvements in quality of life and eating attitudes, with no adverse effects noted, suggesting that while FBBT may not lead to greater weight loss, it can have positive health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. Croker, H., Viner, RM., Nicholls, D., et al.[2022]

The US medical system currently struggles to effectively address childhood obesity, with primary care practices often not aligning with evidence-based recommendations for prevention and treatment.

Collaboration between childhood obesity specialists and primary care providers has shown promise in improving the quality of care for obesity prevention and treatment, highlighting the importance of systematic approaches to tackle this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. Haemer, M., Cluett, S., Hassink, SG., et al.[2022]

A study involving 549 obese children aged 6 to 12 years showed that computerized clinical decision support (CDS) for pediatric clinicians significantly reduced BMI over one year compared to usual care, with a decrease of -0.51 in BMI for the CDS group.

The addition of individualized family coaching to CDS also improved care quality, leading to better adherence to obesity management guidelines, but had a smaller effect on BMI reduction (-0.34) compared to CDS alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial. Taveras, EM., Marshall, R., Kleinman, KP., et al.[2022]

Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.

Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]

Implementing evidence-based guidelines for childhood obesity identification and prevention in primary care significantly increased the identification of at-risk children, with a notable improvement in documentation (p < .0001).

The use of a tracking form during preventative care visits enhanced the delivery of obesity prevention education through motivational interviewing, leading to better engagement with families (p < .05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of childhood obesity identification and prevention strategies in primary care: A quality improvement project. Rankin, A., Blood-Siegfried, J., Vorderstrasse, A., et al.[2023]

Pediatric obesity is a growing global issue, and early identification and treatment of obesity and its related health complications are crucial for improving outcomes in affected children.

Multidisciplinary, behavior-based treatment programs, along with potential options like medication and bariatric surgery, can be effective in managing pediatric obesity, highlighting the need for trained healthcare practitioners in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric obesity: looking into treatment. Pietrobelli, A., Rugolotto, S., Cristofaro, PD., et al.[2021]

A pilot study involving 22 families showed that low-intensity interventions (≤25 contact hours over 6 months) in primary care can effectively reduce children's standardized body mass index (z-BMI).

The study found significant decreases in both z-BMI and the consumption of sugar-sweetened beverages over time, suggesting that these interventions can lead to healthier behaviors in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effect of three low-intensity pediatric obesity interventions: a pilot randomized controlled trial. Looney, SM., Raynor, HA.[2014]

References

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

Expanding the role of primary care in the prevention and treatment of childhood obesity: a review of clinic- and community-based recommendations and interventions. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. [2022]

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

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. [2022]

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

Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial. [2022]

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

Current approaches to the management of pediatric overweight and obesity. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of childhood obesity identification and prevention strategies in primary care: A quality improvement project. [2023]

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

Pediatric obesity: looking into treatment. [2021]

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

Examining the effect of three low-intensity pediatric obesity interventions: a pilot randomized controlled trial. [2014]