ObesityGFHSNCT02939261
Guelph Family Health Study: Full Study
A study testing Intervention - 4 Home Visits in people with Obesity, run by University of Guelph at 1 site in Canada.
Trial summary
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intervention - 4 Home Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to Sep 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 18 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- families who have at least 1 child age 18 months - 5 years
- families who live in the Guelph area
- families who can respond to English surveys
Who cannot join
- plan to move away within the next year
- have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Univeristy of Guelph
Guelph, Ontario, N1G 2W1
Jess Haines, PhD, 519-824-4120 ext. 53780, jhaines@uoguelph.ca
Angela Annis, MSc, 519-824-4120 ext. 56168, aannis@uoguelph.ca
About this study
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The investigators primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study will also assess the cost-effectiveness of the intervention from a societal perspective.
Read the detailed description
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study also assess the cost-effectiveness of the intervention from a societal perspective.
The investigators will randomly allocate 356 socio-economically diverse Ontario families to receive either: 1) 4 motivational coaching home visits, bi-weekly emails, and mailed behaviour supports (intervention group), or 2) Monthly emails with general health information (control group). Primary and secondary outcomes will be assessed at baseline, post-intervention (6-months), and 18-month follow-up, and data will be analyzed by intention to treat.
This study tests a novel and promising approach to obesity prevention - an approach that engages families at home, where they eat, play, and sleep. The interdisciplinary investigator team has partnered with parents and key knowledge users in public health and primary care to develop this intervention. As a result, this research could provide a sustainable model for early life obesity prevention, leading to long-term improvements in health and reduction in costs to the health system and society as a whole.
- Conditions
- Obesity
- Being tested
- Intervention - 4 Home Visits, Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention - 4 Home VisitsBehavioural
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.
ControlBehavioural
monthly emails with general health information
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Families randomized to control will receive monthly emails containing publicly available handouts on general child health. Receives: Behavioral: Control |
| Intervention - 4 Home Visits | Experimental | Families randomized to the intervention will receive: a) 4 home visits from a health educator, b) weekly e-mails, and c) monthly mailed behavioural supports. Receives: Behavioral: Intervention - 4 Home Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child - change in BMI
Trained staff will use standard practices to measure child height to the nearest 0.1 cm with a Shorrboard stadiometer and child weight to the nearest 0.1 kg using a Seca scale. BMI will be the ratio of weight (kg) to the square of standing height (m).
Measured: Baseline, 6 Months and 18 Months
Secondary outcomes (17)
Child - change in waist circumference
Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.
Measured: Baseline, 6 Months, 18 Months
Child - change in % body fat
Trained staff will use bioelectrical impedance analysis to assess child body composition and use the equation by Kusher to determine % body fat.
Measured: Baseline, 6 Months, 18 Months
Child - change in sleep duration
Sleep duration will be assessed using the wActiSleep+ Activity Monitor (ActiGraph). Activity monitors will be worn on the child's non-dominant wrist for 7 consecutive days. Sleep measures will be determined using the validated Sadeh algorithm.
Measured: Baseline, 6 Months, 18 Months
Child - change physical activity
Physical activity will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for physical activity for preschool children will be used to determine physical activity.
Measured: Baseline, 6 Months, 18 Months
Child - change in sedentary behaviour
Sedentary behaviour will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for sedentary behaviour for preschool children will be used to assess sedentary behaviour.
Measured: Baseline, 6 Months, 18 Months
Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).
To assess children's dietary intake, parents will be asked record all food and beverages that their child consumes over a 3-days period (2 weekdays and 1 weekend day). Data will be analyzed for energy and nutrient intake via ESHA nutrient analysis software.
Measured: Baseline, 6 Months, 18 Months
Adult and child - change in family meals
Parents will report frequency of family meals using an item from The Home Environment Inventory.
Measured: Baseline, 6 Months, 18 Months
Adult - change in BMI
Trained staff will use standard practices to measure adult height to the nearest 0.1 cm with a stadiometer and adult weight to the nearest 0.1 kg using a Seca scale. BMI will be the ratio of weight (kg) to the square of standing height (m).
Measured: Baseline, 6 Months, 18 Months
Adult - change in waist circumference
Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.
Measured: Baseline, 6 Months, 18 Months
Adult - change in % body fat
Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.
Measured: Baseline, 6 Months, 18 Months
Adult - change in sleep duration
Sleep duration will be assessed using the wActiSleep+ Activity Monitor (ActiGraph). Activity monitors will be worn on the participants non-dominant wrist for 7 consecutive days. Sleep measures will be determined using the a validated Sadeh algorithm.
Measured: Baseline, 6 Months, 18 Months
Adult - change in physical activity
Physical activity will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the participant's hip for 7 consecutive days. Validated cut-off values for physical activity will be used to determine physical activity.
Measured: Baseline, 6 Months, 18 Months
Adult - change in sedentary behaviour
Sedentary behaviour will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for sedentary behaviour will be used to assess sedentary behaviour.
Measured: Baseline, 6 Months, 18 Months
Adult - change in dietary behaviour
To assess parent's dietary intake, parents will complete one 24-hour recall using the Automated Self-Administered 24-hour-Canada (ASA24®) dietary recall system, a web-based tool that collects and codes 24-hour recalls using the Canadian Nutrient File.
Measured: Baseline, 6 Months, 18 Months
Adult - motivation for lifestyle change
Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.
Measured: Baseline, 6 Months, 18 Months
Social determinants of obesity
The investigators will assess parental education, marital status, annual household income, parental work patterns, food security, parent perception of neighbourhood safety, and access to grocery stores and indoor and outdoor spaces to be physically active.
Measured: Baseline, 6 Months, 18 Months
Cost-effectiveness of Intervention
The cost effectiveness of the study intervention will be assessed from a societal perspective. The direct costs associated with the intervention will be assessed, as well as health services use and indirect patient costs for both intervention and control groups. Direct costs of the intervention will be estimated from process data collected during the intervention. Through surveys at post-intervention, data will also be collected on costs to families for participating in the intervention, including time spent on home visits and other time costs associated with implementing the intervention recommendations. Health services use will be collected from parents and from linkage with administrative datasets (Ontario Health Insurance Plan). Parents will also be asked to report indirect patient costs, including number of missed school/work days.
Measured: Baseline, 6 Months, 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start1 Jun 2017
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jess Haines, University of Guelph
- Investigators
- Jess Haines, PhD, Principal investigator, Unviersity of GuelphDavid Ma, PhD, Study director, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939261
- Sponsor's protocol ID
- 14AP009
- Acronym
- GFHS
- Status last verified
- Sep 2018
- First submitted
- 13 Oct 2016
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacob R, Buchholz AC, Darlington G, Duncan AM, Vallis LA, Chaput JP, Annis A, Nixon M, Irwin JD, Morrow D, Ma DWL, Haines J. Impact of a Home-Based Obesity Prevention Intervention on Children's and Parents' BMI: Findings From the Guelph Family Health Study Randomised Controlled Trial. Pediatr Obes. 2026 Jan;21(1):e70062. doi: 10.1111/ijpo.70062. Epub 2025 Oct 22.
PubMed 41125536Ribey SCS, Coyle-Asbil HJ, Osojnicki K, Coyle-Asbil B, Vallis LA, Darlington G, Duncan AM, Ma DWL, Haines J, Buchholz AC. Associations between objectively measured nighttime sleep duration, sleep timing, and sleep quality and body composition in toddlers in the Guelph Family Health Study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-7. doi: 10.1139/apnm-2024-0244. Epub 2024 Nov 20.
PubMed 39566036Yu J, Mahajan A, Darlington G, Buchholz AC, Duncan AM, Haines J, Ma DWL; Guelph Family Health Study. Free sugar intake from snacks and beverages in Canadian preschool- and toddler-aged children: a cross-sectional study. BMC Nutr. 2023 Mar 8;9(1):44. doi: 10.1186/s40795-023-00702-3.
PubMed 36890595
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guelph Family Health Study: Full Study
- ClinicalTrials.gov ID
- NCT02939261
- Acronym / sponsor ID
- GFHS / 14AP009
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Oct 2016 (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.
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The investigators primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study will also assess the cost-effectiveness of the intervention from a societal perspective.
Detailed description
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study also assess the cost-effectiveness of the intervention from a societal perspective.
The investigators will randomly allocate 356 socio-economically diverse Ontario families to receive either: 1) 4 motivational coaching home visits, bi-weekly emails, and mailed behaviour supports (intervention group), or 2) Monthly emails with general health information (control group). Primary and secondary outcomes will be assessed at baseline, post-intervention (6-months), and 18-month follow-up, and data will be analyzed by intention to treat.
This study tests a novel and promising approach to obesity prevention - an approach that engages families at home, where they eat, play, and sleep. The interdisciplinary investigator team has partnered with parents and key knowledge users in public health and primary care to develop this intervention. As a result, this research could provide a sustainable model for early life obesity prevention, leading to long-term improvements in health and reduction in costs to the health system and society as a whole.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlFamilies randomized to control will receive monthly emails containing publicly available handouts on general child health. |
| Intervention - 4 Home Visits | Experimental | Behavioral: Intervention - 4 Home VisitsFamilies randomized to the intervention will receive: a) 4 home visits from a health educator, b) weekly e-mails, and c) monthly mailed behavioural supports. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- families who have at least 1 child age 18 months - 5 years
- families who live in the Guelph area
- families who can respond to English surveys
Key exclusion criteria (2 listed)
- plan to move away within the next year
- have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.
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 |
|---|---|---|
| Intervention - 4 Home Visits4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports. | Behavioural | Intervention - 4 Home Visits |
| Controlmonthly emails with general health information | Behavioural | Control |
Primary outcome
Child - change in BMI
Time frame: Baseline, 6 Months and 18 Months
Trained staff will use standard practices to measure child height to the nearest 0.1 cm with a Shorrboard stadiometer and child weight to the nearest 0.1 kg using a Seca scale. BMI will be the ratio of weight (kg) to the square of standing height (m).
17 secondary outcomes
Child - change in waist circumference
Time frame: Baseline, 6 Months, 18 Months
Child - change in % body fat
Time frame: Baseline, 6 Months, 18 Months
Child - change in sleep duration
Time frame: Baseline, 6 Months, 18 Months
Child - change physical activity
Time frame: Baseline, 6 Months, 18 Months
Child - change in sedentary behaviour
Time frame: Baseline, 6 Months, 18 Months
Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).
Time frame: Baseline, 6 Months, 18 Months
Adult and child - change in family meals
Time frame: Baseline, 6 Months, 18 Months
Adult - change in BMI
Time frame: Baseline, 6 Months, 18 Months
Adult - change in waist circumference
Time frame: Baseline, 6 Months, 18 Months
Adult - change in % body fat
Time frame: Baseline, 6 Months, 18 Months
Adult - change in sleep duration
Time frame: Baseline, 6 Months, 18 Months
Adult - change in physical activity
Time frame: Baseline, 6 Months, 18 Months
Adult - change in sedentary behaviour
Time frame: Baseline, 6 Months, 18 Months
Adult - change in dietary behaviour
Time frame: Baseline, 6 Months, 18 Months
Adult - motivation for lifestyle change
Time frame: Baseline, 6 Months, 18 Months
Social determinants of obesity
Time frame: Baseline, 6 Months, 18 Months
Cost-effectiveness of Intervention
Time frame: Baseline, 6 Months, 18 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Derived from this study: PubMed 41125536Jacob R, Buchholz AC, Darlington G, Duncan AM, Vallis LA, Chaput JP, Annis A, Nixon M, Irwin JD, Morrow D, Ma DWL, Haines J. Impact of a Home-Based Obesity Prevention Intervention on Children's and Parents' BMI: Findings From the Guelph Family Health Study Randomised Controlled Trial. Pediatr Obes. 2026 Jan;21(1):e70062. doi: 10.1111/ijpo.70062. Epub 2025 Oct 22.
- Derived from this study: PubMed 39566036Ribey SCS, Coyle-Asbil HJ, Osojnicki K, Coyle-Asbil B, Vallis LA, Darlington G, Duncan AM, Ma DWL, Haines J, Buchholz AC. Associations between objectively measured nighttime sleep duration, sleep timing, and sleep quality and body composition in toddlers in the Guelph Family Health Study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-7. doi: 10.1139/apnm-2024-0244. Epub 2024 Nov 20.
- Derived from this study: PubMed 36890595Yu J, Mahajan A, Darlington G, Buchholz AC, Duncan AM, Haines J, Ma DWL; Guelph Family Health Study. Free sugar intake from snacks and beverages in Canadian preschool- and toddler-aged children: a cross-sectional study. BMC Nutr. 2023 Mar 8;9(1):44. doi: 10.1186/s40795-023-00702-3.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Jess Haines, PhD principal investigator
Unviersity of Guelph
David Ma, PhD study director
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention - 4 Home Visits in people with Obesity, run by University of Guelph 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jess Haines, PhD (519-824-4120 ext. 53780, jhaines@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child - change in BMI (time frame: Baseline, 6 Months and 18 Months). 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 NCT02939261, which also lists 3 linked publications.
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 20 Sep 2018.