Healthy Lifestyles Project for Youth Mental Health

(HELP Trial)

Overseen By Research Coordinator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

Disqualifiers: Eating disorder, inappropriate health or family status

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

Compensation: Varies

Number of Visits: 6

130 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on an e-intervention for mental health, so it's likely you can continue your medications, but please confirm with the study team.

What data supports the effectiveness of the Healthy Lifestyles Project e-intervention treatment for youth mental health?

Research shows that lifestyle interventions can improve mental health by enhancing physical activity and reducing health risks, as seen in studies with adults and inpatients with serious mental illness. These interventions have been linked to better psychosocial functioning and overall health, suggesting potential benefits for youth mental health as well. ^{1 2 3 4 5}

Is the Healthy Lifestyles Project safe for children?

The Healthy Lifestyles Programme (HeLP) was implemented in schools to prevent obesity in children and involved lessons on nutrition, physical activity, and avoiding harmful substances like tobacco and alcohol. The studies did not report any safety concerns, suggesting it is generally safe for children. ^{6 7 8 9 10}

How is the Healthy Lifestyles Project e-intervention treatment different from other treatments for youth mental health?

The Healthy Lifestyles Project e-intervention is unique because it focuses on creating supportive environments at school and home to change behavior patterns, using dynamic and creative methods. Unlike traditional treatments, it is school-based, making it easily accessible and non-stigmatizing for young people. ^{7 9 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to learn about how healthcare providers can support youths' mental health. The main question\[s\] it aims to answer are: * Do youth (12 to 17 years of age) who engage in the 6-month HELP e-intervention have a larger improvement in emotional health (measured by the Strengths and Difficulties Questionnaire) than youth who do not receive the intervention? * Does engagement in the HELP e-intervention improve lifestyle behaviour (physical activity, sleep or screen time)? * Do youth who engage in the 6-month HELP e-intervention utilize fewer mental healthcare resources, during and for 1 year following study participation, than youth who do not receive the intervention? Participants will receive the HELP intervention for 6 months, either immediately or after waiting 6 months from study enrollment. At 0, 3, 6, and 12 months, participants will answer a series of questionnaires to assess their emotional health and lifestyle behaviors. Researchers will compare the emotional health and lifestyle behaviors of youth who received HELP immediately to those who wait for 6 months prior to the intervention to see if their emotional health or lifestyle behaviors differ.

Research Team

Clare Gray, MD

Principal Investigator

Children's Hospital of Eastern Ontario

Eligibility Criteria

This trial is for youths aged 12-17 experiencing emotional distress, who can interact in English and consent to study participation. They must be willing to complete questionnaires, potentially provide health record data, and possibly engage in behavior measures if chosen.

Inclusion Criteria

I agree to let my mental health records be used for study.

I am between 12-17 years old and seeking support for emotional distress.

I am a teenager between 12-17 years old looking for help with emotional distress.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

Participants receive the HELP e-intervention with kinesiology support for 6 months

6 months

Assessments at 0, 3, and 6 months

Delayed Intervention

Participants receive the HELP e-intervention with kinesiology support after a 6-month delay

6 months

Assessments at 6 and 12 months

Follow-up

Participants are monitored for sustainability of intervention effects and use of mental healthcare resources

6 months

Treatment Details

Interventions

• Healthy Lifestyles Project e-intervention

Trial Overview The HELP e-intervention aims to improve the mental health of young people through a digital platform over six months. The study will assess changes in emotional well-being and lifestyle behaviors like physical activity and screen time.

Participant Groups

Group I: Immediate Intervention Experimental Treatment 1 Intervention

Access to HELP e-intervention from 0 to 6 months with kinesiology support.

Group II: Delayed Intervention Active Control 1 Intervention

Access to HELP e-intervention from 6 to 12 months with kinesiology support.

Who Is Running the Clinical Trial?

Children's Hospital of Eastern Ontario

Lead Sponsor

Trials

134

Recruited

61,000+

Children's Hospital Academic Medical Organization (CHAMO)

Collaborator

Trials

1

Recruited

130+

The Physicians' Services Incorporated Foundation

Collaborator

Trials

165

Recruited

31,700+

Findings from Research

In a study of 126 participants over 6 months, improvements in mental health were linked to better lifestyle choices, such as increased physical activity, reduced calorie intake, and improved sleep, particularly in those whose mental health improved from poor to good.

Participants who maintained good mental health showed significant improvements in physical health markers, including decreased triglycerides and increased HDL cholesterol, highlighting the connection between mental and physical well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relationship between the change of mental health and the improvement of lifestyle and physical health]. Ishihara, R., Babazono, A., Kame, C., et al.[2019]

A multidisciplinary lifestyle enhancement treatment (MULTI) significantly improved physical activity, cardiometabolic risk factors, and psychosocial functioning in inpatients with severe mental illness (SMI) after 18 months, compared to standard treatment (TAU).

The implementation of MULTI faced challenges due to organizational factors, but was supported by positive attitudes from both healthcare professionals and patients, highlighting the importance of engagement in lifestyle changes for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. Deenik, J., Tenback, DE., Tak, ECPM., et al.[2021]

Only three studies were found that assessed physical health interventions for adolescents in mental health inpatient settings, indicating a significant gap in research in this area.

Preliminary results from these studies suggest that lifestyle interventions, such as gym-based activities, sports, and yoga, may improve overall health and physical measurements in adolescent inpatients, highlighting the need for further research to optimize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical health interventions on adolescent mental health inpatient units: A systematic review and call to action. Carney, R., Imran, S., Law, H., et al.[2022]

Lifestyle interventions for individuals with serious mental illness can lead to significant improvements in weight loss and metabolic syndrome risk factors, as shown in 12 out of 23 reviewed studies.

There is a notable lack of representation of racial and ethnic minority groups in these studies, which limits the generalizability of the findings, particularly for Hispanics and Asian Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for adults with serious mental illness: a systematic literature review. Cabassa, LJ., Ezell, JM., Lewis-Fernández, R.[2021]

The 'Meals, Mindfulness, & Moving Forward' (M3) program demonstrated high adherence, with 88% of participants successfully following the 6-week lifestyle intervention designed for youth with a history of psychosis.

Participants in the M3 program showed significant improvements in positive psychotic symptoms compared to controls, indicating the potential efficacy of lifestyle interventions in managing mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meals, Mindfulness, & Moving Forward: A feasibility study to a multi-modal lifestyle approach in early psychosis. Usher, C., Thompson, A., Griebeler, M., et al.[2021]

The HeLP trial is a large-scale, cluster randomized controlled trial aimed at preventing obesity in 9-10 year-old children, focusing on the effectiveness and cost-effectiveness of a school-based intervention.

The study includes detailed statistical analysis plans to ensure robust results, including primary and secondary outcomes, sensitivity analyses, and adherence-adjusted analyses, which will help accurately assess the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children. Creanor, S., Lloyd, J., Hillsdon, M., et al.[2022]

The Healthy Lifestyles Programme (HeLP) is a school-based intervention designed to prevent obesity in children, targeting 1,300 participants aged 9 to 10 years across 32 schools in the southwest of England, with a focus on interactive and creative methods.

The primary outcome of the trial is to measure changes in body mass index (BMI) over 24 months, with secondary outcomes including waist circumference and physical activity levels, aiming to provide evidence on the program's effectiveness and cost-effectiveness in combating childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial. Wyatt, KM., Lloyd, JJ., Abraham, C., et al.[2022]

The 'healthy lifestyle programme' implemented in selected high schools led to significant improvements in students' attitudes and knowledge about health and nutrition over three years.

Students in schools where the programme was well-implemented showed a reduction in cigarette smoking, highlighting the programme's effectiveness in promoting healthier lifestyle choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health lifestyle education in high schools. A three-year follow-up study. Simons, LA., Simons, J.[2021]

The Healthy Lifestyles Programme (HeLP) successfully engaged over 90% of 676 participating children across 16 schools, demonstrating high levels of participation and enjoyment, particularly in interactive activities like drama workshops.

The intervention was delivered with high fidelity (94-100% completion) and was well-received by teachers, indicating that it can be effectively implemented in schools to promote healthy behaviors and prevent obesity among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation. Lloyd, J., Dean, S., Creanor, S., et al.[2022]

A study involving nearly 1700 elementary school children showed that combining increased physical activity with healthy nutrition led to a significant decrease in BMI z-scores, while physical activity alone had little effect and the control group saw an increase in BMI z-scores.

The program's cost-effectiveness was notable, costing only 1 euro per child per day, highlighting the potential for lifestyle interventions to combat childhood obesity in a financially sustainable way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects and costs of The Healthy Primary School of the Future]. van Schayck, CP., Willeboordse, M., Oosterhof, M., et al.[2021]

The COPE Healthy Lifestyles TEEN program significantly improved healthy lifestyle choices and reduced depressive and anxiety symptoms among 19 Hispanic adolescents in a pilot study.

Overweight adolescents in the COPE program showed improvements in physical health, including decreased triglycerides and increased HDL levels, alongside enhanced nutrition knowledge and healthy lifestyle beliefs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the mental health, healthy lifestyle choices, and physical health of Hispanic adolescents: a randomized controlled pilot study. Melnyk, BM., Jacobson, D., Kelly, S., et al.[2021]

Mental disorders significantly impact the health of children and adolescents, making schools an ideal setting for promoting mental health and delivering healthcare services due to their accessibility and community links.

This special issue compiles systematic reviews on various school-based interventions aimed at improving mental health and wellbeing, highlighting the need for European policies to support these initiatives for better outcomes in young people's mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of International Literature on School Interventions to Promote Mental Health and Well-being in Children and Adolescents. Carta, MG., Fiandra, TD., Rampazzo, L., et al.[2022]

The Wave Project, a six-week surfing intervention for 84 young people aged 8 to 18 facing mental health issues, significantly improved their wellbeing and confidence, with effects lasting for at least a year.

After the program, 70% of participants continued to engage with surfing clubs, and parents reported improvements in their children's attitudes, communication, and behavior at home and school, highlighting the intervention's effectiveness in promoting social integration and mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The positive impact of structured surfing courses on the wellbeing of vulnerable young people. Godfrey, C., Devine-Wright, H., Taylor, J.[2015]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Relationship between the change of mental health and the improvement of lifestyle and physical health]. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Physical health interventions on adolescent mental health inpatient units: A systematic review and call to action. [2022]

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

Lifestyle interventions for adults with serious mental illness: a systematic literature review. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

Meals, Mindfulness, & Moving Forward: A feasibility study to a multi-modal lifestyle approach in early psychosis. [2021]

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

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Health lifestyle education in high schools. A three-year follow-up study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Effects and costs of The Healthy Primary School of the Future]. [2021]

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

Improving the mental health, healthy lifestyle choices, and physical health of Hispanic adolescents: a randomized controlled pilot study. [2021]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

An Overview of International Literature on School Interventions to Promote Mental Health and Well-being in Children and Adolescents. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The positive impact of structured surfing courses on the wellbeing of vulnerable young people. [2015]