Health Knowledge, Attitudes, PracticeNCT03550248
Healthy Together Program Evaluation (Phase 3)
A study testing Healthy Together in people with Health Knowledge, Attitudes, Practice and Overweight and Obesity, run by University of British Columbia at 1 site in Canada.
Trial summary
Healthy Together is a program that promotes the achievement and maintenance of healthy weights in children and their families. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Overweight and Obesity
- What is being tested?
- Healthy Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Family members who have not participated in any of the HT sessions offered as part of on-going services provided by the partner organization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Weights for Children Project (Phase 3)
Healthy Together is a program that promotes the achievement and maintenance of healthy weights in children and their families.
Read the 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.
- Being tested
- Healthy Together
- Keywords
- Healthy Weights, Health Promotion, Scale-up, Family Health, Prevention, Childhood Obesity, Physical Activity, Cooking Activity, Family education model
- Medical subject headings
- Behavior, Overweight, Obesity, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy TogetherBehavioural
Also called Healthy Together Children's Health Program
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Participants will receive the intervention - Healthy Together (HT). Receives: Behavioral: Healthy Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Physical Activity Behaviour
Godin Physical Activity Leisure Time Questionnaire
Measured: 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)
Changes in Healthy Eating
Self-reported changes in eating behavior because of participation in the HT program using validated survey questions
Measured: 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 outcomes (1)
Knowledge of healthy diet and physical activity behaviors
Self-reported knowledge using validated survey questions
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Mar 2017
- Primary completion30 Apr 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participating organizations will deliver the Healthy Together (HT) program to children/youth and their parents/caregivers. Participants in the program will be invited to complete questionnaires to evaluate the program at mid point (after 15 sessions) and post program (after 30 sessions).
- Masking
- None (open label)
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), The Bridge Youth and Family Services, Kelowna, BC, Canada
- Responsible party
- Principal investigator, Joan Bottorff, University of British Columbia
- Investigators
- Joan L Bottorff, PhD, RN, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550248
- Sponsor's protocol ID
- 1415-HQ-000616.
- Status last verified
- Oct 2020
- First submitted
- 25 May 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bottorff JL, Huisken A, Hopkins M, Nesmith C. A RE-AIM evaluation of Healthy Together: a family-centred program to support children's healthy weights. BMC Public Health. 2020 Nov 23;20(1):1754. doi: 10.1186/s12889-020-09737-8.
PubMed 33225915
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Weights for Children Project (Phase 3)
- ClinicalTrials.gov ID
- NCT03550248
- Acronym / sponsor ID
- 1415-HQ-000616.
- Keywords
- Healthy Weights, Health Promotion, Scale-up, Family Health, Prevention, Childhood Obesity, Physical Activity, Cooking Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), The Bridge Youth and Family Services, Kelowna, BC, Canada
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy Together is a program that promotes the achievement and maintenance of healthy weights in children and their families.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participating organizations will deliver the Healthy Together (HT) program to children/youth and their parents/caregivers. Participants in the program will be invited to complete questionnaires to evaluate the program at mid point (after 15 sessions) and post program (after 30 sessions).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Behavioral: Healthy TogetherParticipants will receive the intervention - Healthy Together (HT). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Family members who have not participated in any of the HT sessions offered as part of on-going services provided by the partner organization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy TogetherAlso: Healthy Together Children's Health ProgramThe 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. | Behavioural | Intervention group |
Primary outcome
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)
Godin Physical Activity Leisure Time Questionnaire
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)
Self-reported changes in eating behavior because of participation in the HT program using validated survey questions
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 33225915Bottorff JL, Huisken A, Hopkins M, Nesmith C. A RE-AIM evaluation of Healthy Together: a family-centred program to support children's healthy weights. BMC Public Health. 2020 Nov 23;20(1):1754. doi: 10.1186/s12889-020-09737-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan L Bottorff, PhD, RN principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Together in people with Health Knowledge, Attitudes, Practice and Overweight and Obesity, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.