Obesity PreventionNCT06777888
Childhood Obesity Management Using Innovative Digital Technology
A study testing Family Healthy Living Program weekly group sessions and Self-guided Web Portal Resources Only in people with Obesity Prevention and Child Behaviour, run by University of Victoria at 1 site in Canada.
Trial summary
The project will evaluate the short- and long-term effects of a 10-week Family Healthy Living Program (FHLP). The program is designed for families with children ages 8-12 years old who are at risk for being above a healthy weight and who would like support with healthy living habits such as physical activity and… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Obesity Prevention, Child Behaviour, Health Behaviour Change
- What is being tested?
- Family Healthy Living Program weekly group sessions and Self-guided Web Portal Resources Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2021to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must be aged 8-12 years with at least one primary caregiver who agrees to participate with them. More than one child per parent will be able to participate if the child meets the inclusion criteria.
- Children must have a BMI ≥ 85th percentile for age and sex.
Who cannot join
- Children below the 85th percentile BMI.
- The inability to communicate (speak, read, and write) in English.
- Any conditions that prevent children from being physically active.
Trial locations and contacts
1 site in 1 country.
About this study
The project will evaluate the short- and long-term effects of a 10-week Family Healthy Living Program (FHLP). The program is designed for families with children ages 8-12 years old who are at risk for being above a healthy weight and who would like support with healthy living habits such as physical activity and healthy eating.
Families will participate together, with both parents and children being involved in the program. FHLP participants will receive 9 weekly 2-hour online group sessions with a facilitation team as well as additional web-based resources. They will be compared to a control group of participating families who will be offered only the self-guided web-based resources. This will help us see the impact of offering facilitated FHLP group sessions versus only offering resources online. The FHLP is 10 weeks long, but participants will be followed for 12 months in total so that researchers can look at the long-term impact of participation.
Read more
All participating families from both groups will be asked to complete surveys and provide child height and weight measurements at four timepoints: before beginning the program, immediately after completing the program, at 6-months post-program, and at 12-months post-program. Children will also be given FitBit activity watches to measure their daily step counts at each timepoint.
Researchers will compare survey responses, child growth patterns, and FitBit step counts between the FHLP participants and the control group to see whether participating in the FHLP helps families improve their healthy living habits more than only offering a similar curriculum of healthy living resources online for families to access on their own.
- Conditions
- Obesity Prevention, Child Behaviour, Health Behaviour Change, Obesity and Overweight, Physical Activity
- Being tested
- Family Healthy Living Program weekly group sessions, Self-guided Web Portal Resources Only
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Healthy Living Program weekly group sessionsBehavioural
Also called Family Healthy Living Intervention, Early Intervention Program, Generation Health Community
Children aged 8-12 and at least one caregiver will meet for 9 weekly virtual group intervention sessions (2 hours per session) with program facilitators and will also have access to a virtual Q and A session and up to 3 virtual cooking classes with a Registered Dietician. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions.
Self-guided Web Portal Resources OnlyBehavioural
Children aged 8-12 and at least one caregiver will be offered access to digital educational content and downloadable resources on topics such as physical activity, healthy eating, and positive mental well-being.
| Study group | Role | What they receive |
|---|---|---|
| Family Healthy Living Program Intervention Group | Experimental | Not described Receives: Behavioral: Family Healthy Living Program weekly group sessions |
| Self-Guided Web Only Group | Other | Not described Receives: Behavioral: Self-guided Web Portal Resources Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI Z-scores
Participants will be asked to self-report measurements of each child's height, weight and age to calculate BMI. Children's BMI z-scores will be calculated based on the World Health Organization criteria. This data will be collected at baseline, 10-week, 6-month and 12-month assessments.
Measured: From enrollment to 12 month follow-up
Secondary outcomes (2)
Improving lifestyle behaviours and quality of life in children
Parents will complete a questionnaire assessing parent support for healthy family lifestyle environment and changes in their child's health-related quality of life. Children will complete questionnaires to assess their physical activity behaviours and dietary behaviours. These questionnaires will be completed at baseline, 10-week, 6-month and 12-month assessments.
Measured: From enrollment to 12 month follow-up
Child physical activity measurements
Changes in physical activity for the child will be measured using FitBit activity trackers. One week of daily step counts will be captured at baseline, 10-week, 6-month and 12-month assessments.
Measured: From enrollment to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Dec 2021
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
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 Obesity PreventionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Liu, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777888
- Sponsor's protocol ID
- H20-00759
- Other IDs
- PJT - 169013
- Status last verified
- Jan 2025
- First submitted
- 2 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be shared with co-investigators.
Publications
Jantzen RR, Naylor PJ, Strange K, Ball GDC, Masse LC, Rhodes RE, Zhang X, Nolan RP, Zheng S, Rac V, Liu S. Evaluating the Effectiveness of a Family-Based Lifestyle Intervention for Managing Childhood Overweight: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 14;14:e76837. doi: 10.2196/76837.
PubMed 41085996
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Obesity Management Using Innovative Digital Technology
- ClinicalTrials.gov ID
- NCT06777888
- Acronym / sponsor ID
- H20-00759
- Conditions
- Obesity Prevention, Child Behaviour, Health Behaviour Change, Obesity and Overweight, Physical Activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Jan 2025 (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.
The project will evaluate the short- and long-term effects of a 10-week Family Healthy Living Program (FHLP). The program is designed for families with children ages 8-12 years old who are at risk for being above a healthy weight and who would like support with healthy living habits such as physical activity and healthy eating.
Families will participate together, with both parents and children being involved in the program. FHLP participants will receive 9 weekly 2-hour online group sessions with a facilitation team as well as additional web-based resources. They will be compared to a control group of participating families who will be offered only the self-guided web-based resources. This will help us see the impact of offering facilitated FHLP group sessions versus only offering resources online. The FHLP is 10 weeks long, but participants will be followed for 12 months in total so that researchers can look at the long-term impact of participation.
All participating families from both groups will be asked to complete surveys and provide child height and weight measurements at four timepoints: before beginning the program, immediately after completing the program, at 6-months post-program, and at 12-months post-program. Children will also be given FitBit activity watches to measure their daily step counts at each timepoint.
Researchers will compare survey responses, child growth patterns, and FitBit step counts between the FHLP participants and the control group to see whether participating in the FHLP helps families improve their healthy living habits more than only offering a similar curriculum of healthy living resources online for families to access on their own.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Healthy Living Program Intervention Group | Experimental | Behavioral: Family Healthy Living Program weekly group sessions |
| Self-Guided Web Only Group | Other | Behavioral: Self-guided Web Portal Resources Only |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children must be aged 8-12 years with at least one primary caregiver who agrees to participate with them. More than one child per parent will be able to participate if the child meets the inclusion criteria.
- Children must have a BMI ≥ 85th percentile for age and sex.
Key exclusion criteria (3 listed)
- Children below the 85th percentile BMI.
- The inability to communicate (speak, read, and write) in English.
- Any conditions that prevent children from being physically active.
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 |
|---|---|---|
| Family Healthy Living Program weekly group sessionsAlso: Family Healthy Living Intervention, Early Intervention Program, Generation Health CommunityChildren aged 8-12 and at least one caregiver will meet for 9 weekly virtual group intervention sessions (2 hours per session) with program facilitators and will also have access to a virtual Q and A session and up to 3 virtual cooking classes with a Registered Dietician. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. | Behavioural | Family Healthy Living Program Intervention Group |
| Self-guided Web Portal Resources OnlyChildren aged 8-12 and at least one caregiver will be offered access to digital educational content and downloadable resources on topics such as physical activity, healthy eating, and positive mental well-being. | Behavioural | Self-Guided Web Only Group |
Primary outcome
Child BMI Z-scores
Time frame: From enrollment to 12 month follow-up
Participants will be asked to self-report measurements of each child's height, weight and age to calculate BMI. Children's BMI z-scores will be calculated based on the World Health Organization criteria. This data will be collected at baseline, 10-week, 6-month and 12-month assessments.
2 secondary outcomes
Improving lifestyle behaviours and quality of life in children
Time frame: From enrollment to 12 month follow-up
Child physical activity measurements
Time frame: From enrollment to 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 41085996Jantzen RR, Naylor PJ, Strange K, Ball GDC, Masse LC, Rhodes RE, Zhang X, Nolan RP, Zheng S, Rac V, Liu S. Evaluating the Effectiveness of a Family-Based Lifestyle Intervention for Managing Childhood Overweight: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 14;14:e76837. doi: 10.2196/76837.
- Individual participant dataSharing planned: No. Individual participant data will only be shared with co-investigators.
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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.
Sam Liu principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Healthy Living Program weekly group sessions and Self-guided Web Portal Resources Only in people with Obesity Prevention and Child Behaviour, run by University of Victoria 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child BMI Z-scores (time frame: From enrollment to 12 month follow-up). 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 NCT06777888, 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 16 Jan 2025.