- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03550248
Healthy Together Program Evaluation (Phase 3)
Healthy Weights for Children Project (Phase 3)
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of the Phase 3 scale up project is to expand the reach and impact of Healthy Together (HT), by supporting the integration of the HT program into core services of organizations serving children (up to 18 years) and families, particularly those from under-served populations across diverse communities and settings in Canada. The HT program offers a flexible, effective, integrated approach, relevant to multiple contexts, creating potential to become a sustainable approach to promoting healthier weights in Canadian children. The objectives of the evaluation for Phase 3 are to:
- Describe the effectiveness of the HT program in relation to knowledge, attitude and behavior change at the individual, family, and community level.
- Monitor quality and sustainability of HT, when offered as part of core service by organizations to meet diverse community needs and cultural contexts.
- Create an effective knowledge mobilization framework to increase practice and policy influence of HT, in collaboration with regional, provincial and national networks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Kelowna, British Columbia, Canada
- Bridge Youth and Family Services
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Community partner organizations with capacity and infrastructure to implement the HT program are eligible to be implementation sites. Priority is given to community organizations serving Indigenous, immigrants/refugees, low income/low literacy groups, and families residing in rural communities. All sites will be required to integrate HT into their existing services.
Inclusion criteria for each participant group are as follows:
Families: HT is designed for children (up to 18 years of age) and families. Children and families participating in programs offered by the partner organizations are eligible to attend HT. All interested families will be able to access the program regardless of their previous knowledge or skill level. Participants do not have to be overweight/obese to participate in sessions.
HT Facilitators: Staff members who are identified by the partner organizations, trained to implement the HT program and directly involved in HT program delivery will be eligible to participate in the evaluation.
Directors of Partner Organizations: Partner organizations will be asked to identify a director (supervisor) that has administrative responsibility for overseeing the delivery of services for children/families that includes the HT program.
National Advisory Committee (NAC): Members of the National Advisory Committee established by The Bridge Youth and Family Service Society for Phase 3 of this project.
Exclusion Criteria:
Family members who have not participated in any of the HT sessions offered as part of on-going services provided by the partner organization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention group
Participants will receive the intervention - Healthy Together (HT).
|
The Healthy Together (HT) program is designed to reduce overweight and obesity among children and youth in priority populations such as Indigenous, immigrant and refugee, and low income families.The HT program consists of 30 sessions, each of which includes cooking and eating together, physical activity and a learning activity covering topics that promote healthy weights.
The HT program is delivered by trained facilitators who are provided with a program manual and resources.
Trained facilitators in participating community organizations offer the HT program by integrating it within core programming.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Physical Activity Behaviour
Time Frame: At mid point in the HT program (i.e., following the first 15 weekly sessions) and at HT program completion (i.e., following the second set of 15 weekly sessions)
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Godin Physical Activity Leisure Time Questionnaire
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At mid point in the HT program (i.e., following the first 15 weekly sessions) and at HT program completion (i.e., following the second set of 15 weekly sessions)
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Changes in Healthy Eating
Time Frame: At mid point in the HT program (i.e., following the first 15 weekly sessions) and at HT program completion (i.e., following the second set of 15 weekly sessions)
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Self-reported changes in eating behavior because of participation in the HT program using validated survey questions
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At mid point in the HT program (i.e., following the first 15 weekly sessions) and at HT program completion (i.e., following the second set of 15 weekly sessions)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of healthy diet and physical activity behaviors
Time Frame: At mid point in the HT program (i.e., following the first 15 weekly sessions) and at HT program completion (i.e., following the second set of 15 weekly sessions)
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Self-reported knowledge using validated survey questions
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At mid point in the HT program (i.e., following the first 15 weekly sessions) and at HT program completion (i.e., following the second set of 15 weekly sessions)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustainability assessment (HT program implementation)
Time Frame: At HT program completion (i.e., following delivery of 30 weekly sessions) and 1 year follow-up
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Perceptions of HT program maintenance and sustainability from directors & facilitators - using semi-structured telephone interviews
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At HT program completion (i.e., following delivery of 30 weekly sessions) and 1 year follow-up
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Level of success in increasing practice and policy influence of the HT program
Time Frame: Year 1, 2, and 3
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Semi-structured interviews with Directors and National Advisory Committee Members
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Year 1, 2, and 3
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joan L Bottorff, PhD, RN, University of British Columbia
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1415-HQ-000616.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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