NCT02939261

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

October 13, 2016

Last Update Submit

September 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 6 Months and 18 Months

Secondary Outcomes (17)

  • Child - change in waist circumference

    Baseline, 6 Months, 18 Months

  • Child - change in % body fat

    Baseline, 6 Months, 18 Months

  • Child - change in sleep duration

    Baseline, 6 Months, 18 Months

  • Child - change physical activity

    Baseline, 6 Months, 18 Months

  • Child - change in sedentary behaviour

    Baseline, 6 Months, 18 Months

  • +12 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Families randomized to control will receive monthly emails containing publicly available handouts on general child health.

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.

Behavioral: Intervention - 4 Home Visits

Interventions

4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.

Intervention - 4 Home Visits
ControlBEHAVIORAL

monthly emails with general health information

Control

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • plan to move away within the next year
  • have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Guelph

Guelph, Ontario, N1G 2W1, Canada

RECRUITING

Related Publications (3)

  • 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.

  • Ribey 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.

  • Yu 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jess Haines, PhD

    Unviersity of Guelph

    PRINCIPAL INVESTIGATOR
  • David Ma, PhD

    University of Guelph

    STUDY DIRECTOR

Central Study Contacts

Jess Haines, PhD

CONTACT

Angela Annis, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor/GFHS Associate Director

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 20, 2016

Study Start

June 1, 2017

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

September 20, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations