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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03550248
Other study ID # 1415-HQ-000616.
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date March 30, 2020

Study information

Verified date October 2020
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Healthy Together is a program that promotes the achievement and maintenance of healthy weights in children and their families.


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: 1. Describe the effectiveness of the HT program in relation to knowledge, attitude and behavior change at the individual, family, and community level. 2. Monitor quality and sustainability of HT, when offered as part of core service by organizations to meet diverse community needs and cultural contexts. 3. Create an effective knowledge mobilization framework to increase practice and policy influence of HT, in collaboration with regional, provincial and national networks.


Recruitment information / eligibility

Status Completed
Enrollment 3400
Est. completion date March 30, 2020
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Together
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.

Locations

Country Name City State
Canada Bridge Youth and Family Services Kelowna British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia Public Health Agency of Canada (PHAC), The Bridge Youth and Family Services, Kelowna, BC, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Sustainability assessment (HT program implementation) Perceptions of HT program maintenance and sustainability from directors & facilitators - using semi-structured telephone interviews At HT program completion (i.e., following delivery of 30 weekly sessions) and 1 year follow-up
Other Level of success in increasing practice and policy influence of the HT program Semi-structured interviews with Directors and National Advisory Committee Members Year 1, 2, and 3
Primary Changes in Physical Activity Behaviour Godin Physical Activity Leisure Time Questionnaire 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)
Primary Changes in Healthy Eating Self-reported changes in eating behavior because of participation in the HT program using validated survey questions 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)
Secondary Knowledge of healthy diet and physical activity behaviors Self-reported knowledge using validated survey questions 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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