Childhood ObesityFOR HEALTHNCT01698606
FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children
A study testing Multidisciplinary, family-centered lifestyle intervention with behavioral counseling in people with Childhood Obesity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants'… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to 15 Apr 2019
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-6 on study entry with primary overweight or obesity, BMI => 85th percentile for age and sex on 2010 WHO Growth Charts for Canada
- Family meets Readiness for change criteria, contemplation or higher stage, according to Prochaskas Transtheoretical Model.
- At least one parent/caregiver committed to attend all the program sessions with the child
- Parent/caregiver is agreeing to complete the study questionnaires at the required time points
Who cannot join
- Chronic medical conditions potentially impacting program participation or associated with a potentially increased risk in participation (e.g. type 1 diabetes mellitus, heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical, developmental or psychological disabilities that could limit extent of study participation
- Regular use of medications that could limit extent of study participation
- Other concurrent or recently (last 12 months)received obesity treatment
- Inability to read, speak, and/or verbally understand English
- Living outside of the greater London, Ontario, area
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5W9
About this study
Official title: FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience for Overweight and Obese Preschool Children and Their Families - a Pilot Trial.
In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants' degree of overweight (BMI z-score) and in improving quality of life.
In the final phase (phase 3), participating children will be randomized to either receiving a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6 months later (control or wait list arm), in order to generate more robust effectiveness data. Participants will receive an additional free 6-month YMCA membership while participating in the study.
- Conditions
- Childhood Obesity
- Being tested
- Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
- Keywords
- childhood obesity, multidisciplinary, preschool children, community-based, lifestyle intervention, family-centered
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary, family-centered lifestyle intervention with behavioral counselingBehavioural
Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.
| Study group | Role | What they receive |
|---|---|---|
| Secondary lifestyle intervention arm | Active comparator | 6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1. Receives: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling |
| Primary lifestyle intervention arm | Experimental | First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling Receives: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score
Change in BMI z-score
Measured: Baseline, 3, 6, 9, 12 months
Secondary outcomes (8)
Change in Quality of Life Scores (PedsQL 4.0)
Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).
Measured: Baseline, 3, 6, 9, 12 months
Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)
Measured: Baseline, 3, 6, 9, 12 months
Change in parent-reported daily screen-time (TV, computer)
Parent-reported daily screen-time, estimated to the nearest 15 minutes.
Measured: Baseline, 3, 6, 9, 12 months
Change in fruit & vegetable consumption assessed by 3-day food records
Measured: Baseline, 3, 6, 9, 12 months
Change in dairy-product consumption assessed by 3-day food records
Measured: Baseline, 3, 6, 9, 12 months
Change in grain-product consumption assessed by 3-day food records
Measured: Baseline, 3, 6, 9, 12 months
Change in consumption of sugar-sweetened beverages assessed by 3-day food records
Measured: Baseline, 3, 6, 9, 12 months
Change in percent overBMI
Percent overBMI is the percentage above the 50th percentile of BMI for the respective age and gender [(BMI-BMI at 50th percentile)]/BMI at 50th percentile]*100
Measured: Baseline, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startJan 2013
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Why it stopped: Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Bock, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Dirk E. Bock, M.D., Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698606
- Sponsor's protocol ID
- 103011
- Acronym
- FOR HEALTH
- Status last verified
- May 2019
- First submitted
- 1 Oct 2012
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience for Overweight and Obese Preschool Children and Their Families - a Pilot Trial.
- ClinicalTrials.gov ID
- NCT01698606
- Acronym / sponsor ID
- FOR HEALTH / 103011
- Conditions
- Childhood Obesity
- Keywords
- childhood obesity, multidisciplinary, preschool children, community-based, lifestyle intervention, family-centered
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).
- Enrolment
- 11 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 3 Oct 2012 (estimated)
- 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.
In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants' degree of overweight (BMI z-score) and in improving quality of life.
In the final phase (phase 3), participating children will be randomized to either receiving a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6 months later (control or wait list arm), in order to generate more robust effectiveness data. Participants will receive an additional free 6-month YMCA membership while participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secondary lifestyle intervention arm | Active comparator | Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1. |
| Primary lifestyle intervention arm | Experimental | Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counselingFirst arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 2-6 on study entry with primary overweight or obesity, BMI => 85th percentile for age and sex on 2010 WHO Growth Charts for Canada
- Family meets Readiness for change criteria, contemplation or higher stage, according to Prochaskas Transtheoretical Model.
- At least one parent/caregiver committed to attend all the program sessions with the child
- Parent/caregiver is agreeing to complete the study questionnaires at the required time points
Key exclusion criteria (5 listed)
- Chronic medical conditions potentially impacting program participation or associated with a potentially increased risk in participation (e.g. type 1 diabetes mellitus, heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical, developmental or psychological disabilities that could limit extent of study participation
- Regular use of medications that could limit extent of study participation
- Other concurrent or recently (last 12 months)received obesity treatment
- Inability to read, speak, and/or verbally understand English
- Living outside of the greater London, Ontario, area
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 |
|---|---|---|
| Multidisciplinary, family-centered lifestyle intervention with behavioral counselingParent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play. | Behavioural | Primary lifestyle intervention arm, Secondary lifestyle intervention arm |
Primary outcome
BMI z-score
Time frame: Baseline, 3, 6, 9, 12 months
Change in BMI z-score
8 secondary outcomes
Change in Quality of Life Scores (PedsQL 4.0)
Time frame: Baseline, 3, 6, 9, 12 months
Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)
Time frame: Baseline, 3, 6, 9, 12 months
Change in parent-reported daily screen-time (TV, computer)
Time frame: Baseline, 3, 6, 9, 12 months
Change in fruit & vegetable consumption assessed by 3-day food records
Time frame: Baseline, 3, 6, 9, 12 months
Change in dairy-product consumption assessed by 3-day food records
Time frame: Baseline, 3, 6, 9, 12 months
Change in grain-product consumption assessed by 3-day food records
Time frame: Baseline, 3, 6, 9, 12 months
Change in consumption of sugar-sweetened beverages assessed by 3-day food records
Time frame: Baseline, 3, 6, 9, 12 months
Change in percent overBMI
Time frame: Baseline, 3, 6, 9, 12 months
Results and safety
The study was stopped early (reason given: Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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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.
Dirk E. Bock, M.D. principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary, family-centered lifestyle intervention with behavioral counseling in people with Childhood Obesity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 May 2019. 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 was stopped early (reason given: Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).). Results are not available in the source record.
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?
BMI z-score (time frame: Baseline, 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2019.