HeLP vs Usual Care for Childhood Obesity

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach for treating childhood obesity by comparing two different programs. One group receives standard obesity treatment from their primary care doctors, while the other joins the Healthy Living Program (also known as La Vida Saludable), which includes family-focused sessions at community centers. The trial targets children aged 2-16 identified as overweight or obese by their primary care providers. Families who speak English or Spanish and are not currently in another obesity program may be eligible to join. As an unphased trial, this study offers families the chance to contribute to innovative research that could shape future obesity treatments.

Will I have to stop taking my current medications?

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

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

Research has shown that the Healthy Living Program (HeLP) has collaborated with Hispanic and Latino communities for over ten years to manage childhood obesity. This program involves the whole family and focuses on lifestyle changes with guidance from health educators. Studies have found it to be a safe and lasting way to manage obesity in children. Similar family-focused programs, like La Vida Buena, have not reported any major side effects, suggesting that HeLP is generally well-tolerated.

In contrast, the Recommended Treatment of Obesity in Primary Care (RTOP) involves advice on healthy living from primary care doctors. This common healthcare practice is usually considered safe and well-received by patients.

Overall, both treatments studied in this trial have a strong safety record, with no serious safety concerns reported in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Living Program/La Vida Saludable trial because it offers a fresh approach to tackling childhood obesity by involving families directly in the treatment process. Unlike standard treatments that typically focus on the child alone, this program includes 12 family group sessions, promoting a supportive environment and cultural inclusivity with sessions in both English and Spanish. Additionally, the program extends into community settings like recreation centers, making it more accessible and engaging for families. This holistic and community-based approach could lead to more sustainable lifestyle changes and better health outcomes for children.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare two approaches to childhood obesity intervention. One arm involves a primary care-based intervention, where families receive healthy lifestyle counseling from trained primary care providers and health educators every three months. Studies have shown that involving families in treatment within children's primary care settings leads to better weight loss results for kids. Reviews of these programs highlight the effectiveness of engaging families in lifestyle counseling to tackle childhood obesity.

The other arm of this trial involves the Healthy Living Program (HeLP), a community-based intervention. Research indicates that HeLP is a bilingual program designed for Latinx youth dealing with obesity. This program has collaborated with Hispanic and Latino community partners for over ten years, and studies have shown promising results. By focusing on family involvement and culturally relevant methods, HeLP aims to effectively support weight management in diverse communities. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew A Haemer, MD MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4512668/

A Review of Primary Care-Based Childhood Obesity ... This review aims to identify randomized controlled trials of pediatric primary care-based obesity interventions.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2805906

Family-Based Behavioral Treatment for Childhood Obesity ... Family-based treatment can be successfully implemented in pediatric primary care settings and leads to improved weight loss outcomes.

3. publications.aap.org publications.aap.org/pediatrics/article/151/2/e2022060640/190443/Clinical-Practice-Guideline-for-the-Evaluation-and

Clinical Practice Guideline for the Evaluation and ... The knowledge and skills to treat childhood obesity have become necessities for clinical teams in pediatric primary and subspecialty care.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04196556

Effectiveness of an Intervention Programme for Childhood ... Objectives. To assess the effectiveness of a programmed family/group intervention to reduce weight in the treatment of obesity in children 7 to 12 years old in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950541024000413

A Quality Improvement Initiative in Pediatric Primary Care The USPSTF found that comprehensive intensive health behavior and lifestyle treatment with a total of 26 contact hours had the strongest evidence for the most ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10842075/

Randomized-Controlled Trial of a Whole-Family Obesity ... We describe the rationale and design of a trial of the Healthy Living Program (HeLP), a bilingual whole-family behavioral obesity prevention and treatment ...

7. news.cuanschutz.edu news.cuanschutz.edu/medicine/program-working-with-hispanic-and-latino-community-partners-to-lessen-impact-of-childhood-obesity

Program Working with Hispanic and Latino Community ... The Healthy Living Program (HeLP)/La Vida Saludable is a family-centered childhood weight management program that began more than 10 years ago.

8. link.springer.com link.springer.com/article/10.1186/s12889-019-7081-x

La Vida Buena (The Good Life) evaluation La Vida Buena (The Good Life) is an 8-week family-focused intervention for Latino children 5–8 years old and their parents or caregivers.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000506

Evaluating the Long-Term Effectiveness of a Structured ... Conclusion. A structured telehealth lifestyle intervention is safe, effective, and sustainable for pediatric obesity management. These findings ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36468422/

Results From La Vida Buena (The Good Life) Objective: To evaluate the effectiveness of the 8-week, community health worker (CHW)-led La Vida Buena childhood obesity program among Latino ...