Healthy Kids+ Program for Health Behaviors in Children

Recruiting at 1 trial location

Overseen By Dejan Magoc, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: New Mexico State University

Disqualifiers: Not enrolled in program

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

Compensation: Varies

Number of Visits: 3

Duration: 30 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years.

Do I have to stop taking my current medications for the trial?

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

What data supports the idea that Healthy Kids+ Program for Health Behaviors in Children is an effective treatment?

The available research shows that similar programs focusing on improving children's nutrition and physical activity have been effective. For example, a 3-year school-based intervention in rural, low-socioeconomic status elementary schools significantly improved children's health behaviors. The percentage of children meeting nutrition recommendations increased from 11% to 23% for girls and 12% to 23% for boys. Physical activity recommendations were met by 16% of girls and 7% of boys, up from 1% and 3%, respectively. This suggests that programs like Healthy Kids+ can effectively promote healthier behaviors in children. ^{1 2 3 4 5}

What safety data exists for the Healthy Kids+ treatment?

The provided research does not directly mention safety data for the Healthy Kids+ program. However, similar programs like Healthy Caregivers-Healthy Children (HC2) and Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) focus on obesity prevention through nutrition and physical activity interventions in childcare settings. These studies emphasize the importance of parental involvement and culturally sensitive strategies, but they do not provide specific safety data for the interventions. ^{6 7 8 9 10}

Is the Healthy Kids+ treatment a promising treatment for improving health behaviors in children?

Yes, the Healthy Kids+ treatment is promising because it focuses on improving physical activity and nutrition in children, which can lead to better fitness, healthier eating habits, and reduced risk of lifestyle-related diseases. ^{11 12 13 14 15}

Research Team

Dejan Magoc, PhD

Principal Investigator

New Mexico State University

Jason Mendoza, PhD

Principal Investigator

Fred Hutch

Eligibility Criteria

This trial is for children aged 8-11 years who are enrolled in the after-school program at certain locations. It's not open to kids who aren't part of these programs.

Inclusion Criteria

Children ages 8-11 years enrolled in the after-school program at the selected sites.

Exclusion Criteria

Children not enrolled in the after-school program at the selected sites.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Healthy Kids+ program three times a week for 30 weeks, focusing on lifestyle behaviors such as physical activity, dietary intake, and sleep

30 weeks

3 sessions per week

Midyear Assessment

A midyear assessment is conducted to evaluate progress in lifestyle behaviors and psychosocial variables

1 week

Follow-up

Participants are monitored for sustained effects on lifestyle behaviors and psychosocial outcomes after the program

4 weeks

Treatment Details

Interventions

• Healthy Kids +

Trial Overview The 'Healthy Kids+' initiative is being tested to see if its weekly activities can improve lifestyle habits, self-confidence, and readiness for change in young children.

Participant Groups

Group I: Healthy Kids + Experimental Treatment 1 Intervention

Three times a week for 30 weeks with each session lasting 1 hour.

Who Is Running the Clinical Trial?

New Mexico State University

Lead Sponsor

Trials

10

Recruited

2,100+

Fred Hutch

Collaborator

Trials

1

Recruited

60+

Findings from Research

The Stanford GOALS trial is a three-year randomized controlled study involving overweight and obese children aged 7 to 11 from low-income Latino neighborhoods, testing a comprehensive intervention aimed at reducing body mass index (BMI) and improving health outcomes.

The intervention includes a combination of community sports programs, family-based strategies to improve diet and reduce screen time, and primary care counseling, making it a multi-faceted approach to tackle childhood obesity in a targeted population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Robinson, TN., Matheson, D., Desai, M., et al.[2022]

A 3-year school-based health promotion intervention significantly improved children's nutrition and physical activity behaviors in four rural, low-socioeconomic elementary schools, with nearly doubling the percentage of children meeting nutrition recommendations (from 11% to 23% for girls and 12% to 23% for boys) and a notable increase in physical activity recommendations (from 1% to 16% for girls and 3% to 7% for boys).

The study suggests that engaging parents and community partnerships can enhance the effectiveness of health interventions, indicating that a broader approach beyond just children-focused education is beneficial for promoting healthy behaviors in disadvantaged populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a 3-year, nutrition and physical activity intervention for children in rural, low-socioeconomic status elementary schools. King, KM., Ling, J.[2022]

The IMPROVE study is a cluster-randomized controlled trial involving 30 schools and approximately 1400 families, designed to evaluate the effectiveness of two different bundles of implementation strategies for the Healthy School Start program over 12 and 24 months.

The study aims to enhance intervention fidelity and monitor health outcomes related to childhood obesity and type 2 diabetes risk in parents, providing insights into effective implementation strategies tailored to specific school contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial. Elinder, LS., Wiklund, CA., Norman, Å., et al.[2021]

The school-based program led to significant reductions in unhealthy nutrients in school lunches, with total fat decreasing by 15.5% and sodium by 40.2% in intervention schools, showing that healthier meal options can be effectively implemented.

Students in intervention schools increased their engagement in moderate-to-vigorous physical activity during physical education classes from less than 10% to about 40% of class time, indicating that structured programs can enhance physical activity levels among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting physical activity and a healthful diet among children: results of a school-based intervention study. Simons-Morton, BG., Parcel, GS., Baranowski, T., et al.[2019]

In a study involving 183 preschoolers from 23 daycare facilities, those who adhered to more than 50% of a physical activity intervention increased their moderate to vigorous physical activity by 9 minutes per day and decreased sedentary time by 19 minutes after 12 months.

The results suggest that significant improvements in physical activity levels are only achieved with at least 50% adherence to the intervention, highlighting the importance of consistent participation for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of "JolinchenKids-Fit and Healthy in Daycare" on Children's Objectively Measured Physical Activity: A Cluster-Controlled Study. Brandes, B., Buck, C., Wright, MN., et al.[2023]

The Healthy Caregivers-Healthy Children (HC2) intervention significantly improved the nutrition environment in childcare centers, with nearly double the changes in nutrition scores compared to control centers over two years.

While the physical activity environment showed only slight improvements, the overall combined scores for nutrition and physical activity were higher in intervention centers, indicating that obesity prevention programs can effectively promote healthier environments for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster-randomised trial of the impact of an obesity prevention intervention on childcare centre nutrition and physical activity environment over 2 years. Natale, R., Atem, FD., Lebron, C., et al.[2023]

The Healthy Homes/Healthy Kids Preschool pilot program showed high completion and satisfaction rates among 60 parent-child dyads, indicating that a pediatric primary care-based approach to obesity prevention is feasible and acceptable.

While the overall intervention did not show a significant effect on BMI for all participants, it was particularly effective for children who were already overweight at baseline, suggesting targeted interventions may be beneficial for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study. Sherwood, NE., JaKa, MM., Crain, AL., et al.[2018]

The Healthy School Start Plus intervention, involving 352 six-year-old children across 17 schools, aims to prevent obesity by promoting healthy eating and physical activity through parental involvement and support from teachers and school nurses.

This 6-month program is based on Social Cognitive Theory and includes health information for parents, motivational interviewing, classroom activities, and a web-based diabetes risk self-test, with the expectation that it will be more effective than standard care in improving children's dietary habits and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial. Elinder, LS., Patterson, E., Nyberg, G., et al.[2019]

The home-based program, which required parental involvement, led to more significant dietary changes in third-grade students, including reduced fat intake and increased complex carbohydrates, compared to the school-based program.

Despite initial success in changing dietary habits, these changes did not persist after one year, highlighting the need for ongoing support and engagement to maintain healthy behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent involvement with children's health promotion: a one-year follow-up of the Minnesota home team. Perry, CL., Luepker, RV., Murray, DM., et al.[2019]

The Healthy Caregivers, Healthy Children (HC) Phase 2 project is evaluating how childcare center nutrition and physical activity policies affect preschoolers' dietary habits, activity levels, and body mass index (BMI) in 24 centers serving low-resource families.

The intervention includes a comprehensive curriculum for teachers and parents, along with policies on snacks, beverages, and physical activity, aiming to establish evidence-based practices that could significantly improve child health outcomes in childcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy caregivers-healthy children (HC2) phase 2: Integrating culturally sensitive childhood obesity prevention strategies into childcare center policies. Messiah, SE., Lebron, C., Moise, R., et al.[2018]

The 12-week 'Be a Fit Kid' program successfully improved children's physical activity and nutrition, leading to significant enhancements in body composition, fitness, and dietary habits.

Children who participated in at least 75% of the program experienced notable reductions in total cholesterol and triglyceride levels, indicating potential long-term health benefits and a lower risk of lifestyle-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting healthy lifestyles in children: a pilot program of be a fit kid. Slawta, J., Bentley, J., Smith, J., et al.[2016]

The study involving 383 children and their mothers in Tehran found that mothers' knowledge and positive attitudes towards oral health significantly correlate with better oral health outcomes in their children.

Improving children's oral health may require educational interventions targeting both mothers and children, as mothers' behaviors and attitudes play a crucial role in their children's oral hygiene practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of mothers' lifestyle and health behavior on their children: an exploration for oral health. Nourijelyani, K., Yekaninejad, MS., Eshraghian, MR., et al.[2021]

The Active Healthy Kids Canada (AHKC) Report Card has been instrumental in highlighting the decline in physical activity among Canadian children and youth, providing annual assessments based on research and expert reviews to drive policy change.

The influence of the AHKC Report Card has extended beyond Canada, inspiring similar initiatives in regions like Saskatchewan, Ontario, Louisiana, South Africa, Mexico, and Kenya, demonstrating its effectiveness in promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model of knowledge translation in health: the Active Healthy Kids Canada Report Card on physical activity for children and youth. Colley, RC., Brownrigg, M., Tremblay, MS.[2022]

The Healthy Kids Initiative (HKI) achieved a high completion rate of 89.7% among 1995 obese youth participants over a 12-week program, indicating its effectiveness in engaging youth in health improvement activities.

Participants showed significant improvements in aerobic fitness, depressed mood, and health-related quality of life, suggesting that the program effectively enhances physical and mental health outcomes for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Kids Initiative: Results from the First 2000 Participants. Lemstra, M., Rogers, M.[2022]

Childhood obesity is a major health issue in the U.S., affecting 32.2% of children and adolescents aged 2 to 19, with significant rates of obesity and extreme obesity reported between 2011-2014.

Implementing healthful lifestyle behaviors, including improved nutrition and increased physical activity, is crucial for reducing the risk of chronic diseases like obesity and diabetes in children, highlighting the need for effective community-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Healthy Living Medicine, With a Focus on K-12, Physical Education, and Nutrition. Wong, SS.[2019]

References

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

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. [2022]

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

Results of a 3-year, nutrition and physical activity intervention for children in rural, low-socioeconomic status elementary schools. [2022]

3. England pubmed.ncbi.nlm.nih.gov

IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial. [2021]

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

Promoting physical activity and a healthful diet among children: results of a school-based intervention study. [2019]

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

Impact of "JolinchenKids-Fit and Healthy in Daycare" on Children's Objectively Measured Physical Activity: A Cluster-Controlled Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Cluster-randomised trial of the impact of an obesity prevention intervention on childcare centre nutrition and physical activity environment over 2 years. [2023]

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

Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial. [2019]

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

Parent involvement with children's health promotion: a one-year follow-up of the Minnesota home team. [2019]

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

Healthy caregivers-healthy children (HC2) phase 2: Integrating culturally sensitive childhood obesity prevention strategies into childcare center policies. [2018]

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

Promoting healthy lifestyles in children: a pilot program of be a fit kid. [2016]

12. Estonia pubmed.ncbi.nlm.nih.gov

The influence of mothers' lifestyle and health behavior on their children: an exploration for oral health. [2021]

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

A model of knowledge translation in health: the Active Healthy Kids Canada Report Card on physical activity for children and youth. [2022]

14. New Zealand pubmed.ncbi.nlm.nih.gov

The Healthy Kids Initiative: Results from the First 2000 Participants. [2022]

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

Community-Based Healthy Living Medicine, With a Focus on K-12, Physical Education, and Nutrition. [2019]