Physical Activity Program for Childhood Obesity

(ACTIVE Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: Organized physical activity, Child protection, others

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

Compensation: Varies

Number of Visits: Unknown

1400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help newcomer families in Hamilton, Ontario, access resources for healthy, active living. Researchers seek to determine if these resources change children's perceptions of physical activity and encourage greater participation. The program includes physical activity sessions, guidance from a navigator, and health promotion messages. Families who have been in Canada for 10 years or less, with children aged 5 to 11, and who are not already engaged in frequent organized sports, might be a good fit for this trial. As an unphased study, this trial offers families a unique opportunity to enhance their children's health and activity levels through tailored support and resources.

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 physical activity program is safe for children?

Research has shown that exercise programs are generally safe for children. One study found that exercise reduced body fat in overweight and obese children by 0.4%. Another study discovered that even light to moderate exercise improved children's health. Importantly, these programs reported no serious side effects. High-intensity exercise also improved body shape and insulin use in teenagers with severe obesity, and they tolerated it well. Overall, physical activity is a safe and effective way to support healthy growth in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Physical Activity Program for Childhood Obesity because it offers a comprehensive approach to tackling obesity in kids. Unlike traditional treatments that often focus solely on diet or medication, this program combines physical activity with supportive services like navigator assistance and health promotion messaging. This holistic method is designed to engage children more actively and sustainably, potentially leading to better long-term health outcomes by instilling healthy habits early on.

What evidence suggests that this physical activity program is effective for childhood obesity?

Research has shown that exercise programs can help reduce obesity in children. One study found that physical activity at school improved children's body mass index (BMI), a measure of body fat. Another study demonstrated that these programs effectively prevent and treat obesity, especially when widely implemented. Additionally, combining exercise with behavioral changes helped reduce belly fat. Overall, these findings suggest that increasing physical activity is a powerful way to manage childhood obesity. Participants in this trial will receive a comprehensive intervention that includes physical activity programming, navigator services, and health promotion messaging. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The SCORE! ACTIVE trial is for newcomer families with young children in Hamilton who may not have easy access to healthy active living (HAL) activities. The goal is to see if providing these resources can change the children's views on physical activity and increase their participation in HAL behaviors.

Inclusion Criteria

At least one parent/guardian born outside of Canada and residing in Canada for 10 years or less

Families must be living in one of the designated neighbourhood clusters

I am a newcomer in Canada, living in Hamilton with a child aged 5 to 11.

Exclusion Criteria

Families with involvement with child protection services and/or foster care

My child is in a sports or physical activity program 3+ times a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial baseline measures are taken in each community before the intervention

1-2 weeks

Intervention

Implementation of physical activity programming, navigator services, and health promotion messaging

18 months

Follow-up

Participants are monitored for changes in physical activity self-efficacy and behaviors

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health promotion
• Navigation
• Physical activity program

Trial Overview This study tests a program that includes physical activity, health promotion, and navigation support designed for newcomer families. It aims to assess whether this intervention can positively influence children's attitudes towards physical activity and encourage more active lifestyles.

How Is the Trial Designed?

Group I: SCORE! ACTIVE Experimental Treatment 3 Interventions

This is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Published Research Related to This Trial

A community-based physical activity intervention program in Nanjing, China, significantly increased physical activity levels by an average of 33.13 minutes per week among students, while control group activity levels decreased.

The intervention group showed a smaller increase in body mass index (BMI) and a lower likelihood of obesity at the study's end, indicating the program's effectiveness in preventing obesity among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood obesity prevention through a community-based cluster randomized controlled physical activity intervention among schools in china: the health legacy project of the 2nd world summer youth olympic Games (YOG-Obesity study). Wang, Z., Xu, F., Ye, Q., et al.[2019]

Increasing physical activity is crucial in treating childhood obesity, as it not only helps with weight management but also improves metabolic health and psychological well-being.

The paper provides practical recommendations for healthcare providers to encourage obese children and their families to engage in daily activities, participate in sports, reduce sedentary behaviors, and involve their social circles in supporting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity-key issues in treatment of childhood obesity. Nowicka, P., Flodmark, CE.[2015]

A two-week weight-management camp followed by a 10-week community intervention significantly reduced BMI in overweight and obese Qatari children (n=300), demonstrating effective weight management strategies.

The combination of cognitive behavioral therapy and behavior change techniques in the community program helped maintain weight loss achieved during the camp, indicating its potential for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a multicomponent lifestyle intervention for combatting childhood obesity. Vlaev, I., Taylor, MJ., Taylor, D., et al.[2021]

A community-based program for obese children, which included group counseling and nutrition education, effectively stabilized or reduced weight gain, with participants gaining only 0.28 kg/month compared to 0.62 kg/month in matched controls.

43% of the children in the program showed clinically significant differences in weight gain, and 8 participants even lost weight, highlighting the program's potential effectiveness in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

YMCA program for childhood obesity: a case series. McCormick, DP., Ramirez, M., Caldwell, S., et al.[2022]

This project aims to adapt and evaluate the effectiveness of Physical Activity on Prescription (PAP) for approximately 60 children aged 6 to 12 with obesity, focusing on their physical activity levels and health outcomes over a 12-month period.

The study will assess not only clinical outcomes like BMI and metabolic risk factors but also the feasibility and acceptability of PAP through various implementation metrics, providing insights into how to effectively integrate this intervention into pediatric healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of physical activity on prescription for children with obesity in paediatric health care (IMPA): protocol for a feasibility and evaluation study using quantitative and qualitative methods. Bernhardsson, S., Boman, C., Lundqvist, S., et al.[2022]

A four-phase physical activity intervention for 73 overweight children led to significant weight loss and reduced body fat, which were maintained after one year.

The program combined progressive exercise with motivational strategies, resulting in improved physical activity patterns and the preservation of lean body mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating the obese child to move: the role of structured exercise in pediatric weight management. Sothern, MS., Hunter, S., Suskind, RM., et al.[2019]

A structured weight management program for obese children and adolescents led to significant reductions in body weight, BMI, and BMI percentiles after just 3 months, with continued improvements observed at 6 and 12 months for those who maintained participation.

Children who participated in the program showed improved fitness levels, while control group participants experienced weight gain and increased BMI, highlighting the program's effectiveness in promoting healthier outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined nutritional-behavioral-physical activity intervention for the treatment of childhood obesity--a 7-year summary. Nemet, D., Levi, L., Pantanowitz, M., et al.[2014]

A moderate intensity, progressive resistance training program for obese preadolescent children was implemented safely, with no reported injuries and full compliance over 10 weeks.

Significant reductions in weight, body mass index, and body fat were observed after 10 weeks, and these improvements were maintained at a 1-year follow-up, alongside increases in height and lean body mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of resistance exercise in a multidisciplinary outpatient treatment program for preadolescent obese children. Sothern, MS., Loftin, JM., Udall, JN., et al.[2019]

An integrative review of 55 studies from 2012 to 2022 highlights that increasing physical activity and reducing sedentary behavior in obese children can lead to significant improvements in body composition and cardiometabolic indicators, such as BMI and blood pressure.

Physical activity is identified as a crucial intervention for managing obesity-related health risks in children, emphasizing its role in enhancing overall health outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Health in Pediatric Obesity: A Decade's Research of Physical Activity's Influence on Cardiometabolic Parameters. Gesek, M., Fornal, AD., Zarzycka, D.[2023]

This study aims to evaluate a parental support program designed to promote healthy eating and physical activity in six-year-old children, involving 242 participants from diverse socio-economic backgrounds over a six-month period.

The intervention includes health information, motivational interviewing for parents, and classroom activities, with the goal of improving children's physical activity and dietary habits, potentially providing insights for effective obesity prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A healthy school start - parental support to promote healthy dietary habits and physical activity in children: design and evaluation of a cluster-randomised intervention. Nyberg, G., Sundblom, E., Norman, A., et al.[2022]

Exercise programs combined with dietary changes are effective in treating obesity in children and adolescents, as supported by a review of 13 controlled studies.

There is a need for more research on exercise interventions for obesity, particularly considering factors like adherence, diet, age, gender, and type of exercise to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in treating obesity in children and adolescents. Epstein, LH., Coleman, KJ., Myers, MD.[2019]

A systematic review of 85 studies confirmed that physical activity is effective in reducing overweight and obesity in children and adolescents, with the best results coming from programs that combine aerobic and anaerobic exercises.

For optimal results, it is recommended that children and adolescents engage in at least 180 minutes of moderate-intensity exercise per week, and that family involvement in weight reduction programs significantly enhances effectiveness compared to standard nutrition education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity programmes to reduce overweight and obesity in children and adolescents; a systematic review]. Aguilar Cordero, MJ., Ortegón Piñero, A., Mur Vilar, N., et al.[2022]

Participation in an 8-day summer camp for children with obesity led to a significant increase in moderate- to vigorous-intensity physical activity (MVPA) for male participants, while female participants did not show a similar increase, highlighting a gender difference in response to the camp activities.

The study suggests that summer camps can effectively improve physical activity levels in obese children, but special attention should be given to female participants to enhance their engagement and reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively Measured Physical Activity Increases Only in Males During a Summer Camp for Obese Children. Izzicupo, P., Di Blasio, A., Di Credico, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3782715/

The effect of school-based physical activity interventions on ... This study reviewed the effectiveness of school-based physical activity interventions aimed at reducing overweight, obesity and hypertension in children.

2. sciencedirect.com sciencedirect.com/science/article/pii/S221133552200393X

Outcomes of a 24-month childhood obesity prevention ... The primary outcome was change in child body mass index (BMI) z-score at 24 months. Secondary outcomes included number of positive child and parent changes in ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/oby.23695

Effectiveness of a population‐scaled, school‐based ... The population-scaled, school-based PA intervention was effective in preventing and treating obesity. The effects were the greatest in children initially ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832548

Interventions for Childhood Central Obesity: A Systematic ... Combining dietary changes with physical activity, as well as standalone behavioral interventions, was associated with significantly reduced central obesity.

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1504279/full

Comparative effectiveness of school-based obesity ... Results: The results illustrated that the physical activity (PA) only arm was the most effective intervention in improving BMI (MD: −0.42, 95% credible interval ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7096559/

Exercise in the treatment of childhood obesity - PMC In a meta-analysis study conducted with overweight and obese children, it was found that a 0.4% (0.1–0.7%) reduction in body fat occurred with moderate-high ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-23413-9

Impact of exercise on anthropometric outcomes in children ... Exercise improves anthropometric outcomes in children and adolescents who are overweight or obese. Moderate-to-low-intensity aerobic exercise

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000348

Effect and safety of a physical exercise-based intervention ... High-intensity exercise program improved body composition and insulin resistance in adolescents with severe obesity (SOb). •. Adolescents with SOb responded ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7674497/

Physical Activity in the Prevention of Childhood Obesity Results from meta-analysis show that school-based interventions have positive effects on adiposity-related outcomes in 76 of 115 studies, but 42 ...

10. cdc.gov cdc.gov/nccdphp/divisions-offices/about-the-division-of-nutrition-physical-activity-and-obesity.html

About the Division of Nutrition, Physical Activity, and Obesity Providing data on behaviors related to nutrition and physical activity among children, and how states promote healthy growth and obesity ...