Healthy Lifestyle Program for Childhood Obesity and Asthma

(CHAMPION Trial)

Overseen By Sheila Kelly, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Anorexia nervosa, Pregnant, others

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

Compensation: Varies

Number of Visits: 2

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a program called CHAMPION in helping children with obesity and asthma manage their conditions. It compares two delivery methods: telehealth (online) and in-person sessions. The trial includes monthly individual and group sessions for six months, followed by maintenance with regular coaching calls for another six months. Children aged 6 to 17, diagnosed with asthma and having a BMI at or above the 85th percentile, are ideal candidates for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve health outcomes for children with similar conditions.

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 prior data suggests that this program is safe for children with obesity and asthma?

Research shows that the CHAMPION program, available through telehealth or in person, focuses on lifestyle and asthma management for children who are overweight and have ongoing asthma. Similar programs, like CHAMP (Childhood Health and Asthma Management Program), have been studied and found to be generally well-received. No major reports of negative effects have emerged, suggesting that the CHAMPION program is likely safe for participants.

Since this study does not test a new drug or medical device but instead focuses on lifestyle and behavior changes, the risks are low. The program includes regular individual and group visits to help manage weight and asthma symptoms. This method has successfully improved health outcomes for children with similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHAMPION program because it offers a fresh approach to managing childhood obesity and asthma by integrating lifestyle changes through telehealth and in-person sessions. Unlike traditional treatments that might focus solely on medication or isolated lifestyle advice, CHAMPION combines personalized virtual or in-person visits with regular health coaching calls. This dual approach is designed to be more accessible and engaging for families, potentially leading to better adherence and more sustainable health improvements. By offering both telehealth and in-person options, CHAMPION also provides flexibility, catering to different needs and preferences, which is especially important for maintaining long-term lifestyle changes in children.

What evidence suggests that the CHAMPION program is effective for childhood obesity and asthma?

Research has shown that the CHAMPION program, which emphasizes healthy living and asthma management, holds promise for treating childhood obesity and asthma. Studies have found that family-based lifestyle programs like CHAMP can help children better control their asthma and reduce obesity. The program includes both individual and group sessions to support behavior changes, which have succeeded in similar programs. Previous participants in these interventions have demonstrated improvements in asthma and weight management. In this trial, participants will be assigned to either the online or in-person version of CHAMPION, both designed to provide these benefits. Early results suggest that both versions effectively manage these conditions. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 6-17.9 years with asthma and a BMI in the 85th percentile or higher, indicating overweight or obesity. It's designed to help them manage their weight and asthma either through an online program or in person.

Inclusion Criteria

I am between 6 and 17 years old.

My BMI is in the top 15% for my age and height.

My child has been diagnosed with asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Treatment

Participants receive intensive health behavior and lifestyle treatment, with monthly individual and group visits

6 months

1 individual visit monthly, 1 group visit monthly (virtual or in-person depending on the arm)

Maintenance

Participants continue with maintenance phase, including monthly individual visits and health coaching calls

6 months

1 individual visit monthly, 2 health coaching calls per month (virtual or in-person depending on the arm)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHAMPION

Trial Overview The CHAMPION program is being tested to see if it can effectively help kids with both obesity and asthma. The study compares two ways of delivering this health and lifestyle treatment: face-to-face sessions versus online telehealth sessions.

How Is the Trial Designed?

Group I: CHAMPION via Telehealth Experimental Treatment 1 Intervention

* Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual) * Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month

Group II: CHAMPION via In-Person Active Control 1 Intervention

* Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person) * Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 530 urban children with persistent asthma, those who were overweight or obese experienced more asthma symptoms and activity limitations compared to their normal weight peers, with an average of 4.25 days of symptoms versus 3.42 days in normal weight children.

Overweight/obese children were also more likely to utilize healthcare services, with 47% having visited the emergency department or been hospitalized, yet they did not show an increased use of daily preventive inhaled corticosteroids, indicating a gap in effective asthma management for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma and overweight/obese: double trouble for urban children. Wiesenthal, EN., Fagnano, M., Cook, S., et al.[2018]

The 12-week Living Healthy with Asthma intervention showed significant improvements in children's health, including reduced BMI z-scores and enhanced quality of life for both children and parents, indicating its effectiveness in promoting healthy lifestyle behaviors alongside asthma management.

The intervention was found to be feasible and not inferior to a single asthma self-management intervention, suggesting that combining healthy lifestyle changes with asthma care can be a practical approach for managing multiple health issues in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of a combined lifestyle behaviors and asthma self-management intervention for school-aged children. Horner, SD., Timmerman, GM., McWilliams, BC.[2019]

A multidisciplinary pediatric weight management program showed a small but significant decrease in BMI z-score among high-risk children after 9 months, indicating some improvement in weight status.

The program also led to significant improvements in cardiovascular risk factors, such as total cholesterol and triglyceride levels, highlighting its effectiveness in addressing obesity-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pediatric weight management program for high-risk populations: a preliminary analysis. Skelton, JA., DeMattia, LG., Flores, G.[2009]

A systematic review of 11 studies involving 997 overweight and obese children found no significant short-term improvements in quality of life (QoL) from multidisciplinary intervention (MI) programs compared to control groups.

Long-term results suggested a slight trend towards improved QoL in children participating in MI programs, but this was not statistically significant, indicating that more research is needed to determine the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of multidisciplinary interventions on quality of life in obese children: a systematic review and meta-analysis. Ligthart, KA., Paulis, WD., Djasmo, D., et al.[2022]

In a study of 6454 children and adolescents with obesity, participation in pediatric weight management programs led to a modest median decrease in body mass index (BMI), with significant improvements observed over 12 months.

Factors such as older age (≥12 years), greater severity of obesity, and Hispanic ethnicity were linked to better outcomes in BMI reduction, which also correlated with improvements in cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. Kumar, S., King, EC., Christison, AL., et al.[2020]

Parents of children with obesity reported positive experiences from a web-based intervention aimed at improving healthy behaviors and reducing BMI-SDS, highlighting its effectiveness in promoting lifestyle changes for the entire family.

The study, which involved interviews with 14 parents after a family-based treatment that included group sessions and 12 weeks of online support, revealed themes of increased parental awareness and the introduction of new routines, although some parents also felt guilt and faced challenges in addressing their child's obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Now she prefers jeans, like everyone else…' - Parents' experiences of group- and web-based treatment of children's obesity. Thorén, A., Janson, A., Persson, M.[2021]

In a study of pediatric patients aged 7-18 with persistent asthma, no significant differences were found in asthma control measures (like medication use and lung function) between normal weight, overweight, and obese children.

Interestingly, overweight children had the highest mean FEV1 % (a measure of lung function), suggesting that despite reporting more symptoms, obesity did not correlate with worse asthma control in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric obesity and its effects on asthma control. Giese, JK.[2021]

Children with both asthma and obesity had significantly higher body mass index (BMI) scores and lower sleep duration compared to those with obesity alone, indicating a greater risk for health issues.

While there was a trend towards lower physical activity levels in the asthma and obesity group, dietary intake, health-related quality of life, and parent distress were similar between the two groups, suggesting that asthma may complicate the health challenges faced by obese youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of comorbid asthma and obesity: assessing differences in physical activity, sleep duration, health-related quality of life and parental distress. Fedele, DA., Janicke, DM., Lim, CS., et al.[2014]

Families managing weight in children with asthma are influenced by their perceptions of asthma risks and control, highlighting the need for tailored support that addresses these concerns.

Participants expressed a desire for individualized weight management strategies that consider the unique interaction between asthma and obesity, which could help reduce stigma and promote healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"He's not fat, he just has asthma": a qualitative study exploring weight management in families living with pediatric asthma. Clarke, R., Heath, G., Nagakumar, P., et al.[2022]

The WAVES intervention, a school and family-based healthy lifestyle program aimed at preventing childhood obesity, did not show a statistically significant impact on BMI z scores in children after 15 and 30 months, suggesting limited effectiveness in combating obesity on its own.

Despite the intervention's focus on promoting healthy eating and physical activity, the results indicate that schools alone may not be sufficient to address the childhood obesity epidemic without broader support from various sectors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study). Adab, P., Pallan, MJ., Lancashire, ER., et al.[2022]

In a study of 137 obese children attending a UK hospital-based obesity service, 70% achieved reductions in Body Mass Index Standard Deviation Score (BMI SDS), with 18% reaching the target reduction of -0.5 or greater, indicating that lifestyle modifications can be effective.

Younger children showed the most significant improvements in BMI SDS, particularly boys without a parental history of obesity, suggesting that early intervention is crucial for successful weight management in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which factors are associated with a successful outcome in a weight management programme for obese children? Sabin, MA., Ford, A., Hunt, L., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02303561

The Childhood Health and Asthma Management Program The aims of this study are to develop and test the Childhood Health and Asthma Management Program (CHAMP), a behavioral family-based lifestyle intervention ...

2. trialx.com trialx.com/clinical-trials/listings/322628/comparative-effectiveness-of-a-healthy-lifestyle-and-asthma-management-program-in-person-vs-online/

Comparative-effectiveness of a Healthy Lifestyle and ... Overview. The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma ...

3. withpower.com withpower.com/trial/phase-asthma-6-2024-11dfb

Healthy Lifestyle Program for Childhood Obesity and Asthma The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420301993

A community-based asthma program: Study design and ... The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30416909/

A Behavioral Family Intervention for Children with Overweight ... Methods: A sample of 24 children (Mage = 8.67) with asthma and a BMI ≥ 85th percentile and their caregivers participated in a pilot randomized controlled trial.

6. medicalnewstoday.com medicalnewstoday.com/articles/how-tennessee-champ-program-has-improved-life-for-children-with-asthma

Children with asthma: How Tennessee CHAMP program ... The CHAMP program aims to improve asthma management for children who experience frequent and severe asthma exacerbations and preventable hospital visits.

7. healthvermont.gov healthvermont.gov/media/current-news-releases/schools-are-taking-steps-create-asthma-friendly-environments

Schools Are Taking Steps to Create Asthma-Friendly ... The Asthma-friendly Schools Program works with schools to make it easier to support the health of all students. Steps schools can take include:.