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Completed

NCT Number: NCT02223234

Guelph Family Health Study: Pilot Study

The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.

To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.

We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:

1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period. 2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes) 3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.

We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Guelph

Guelph, Ontario, N1G 2W1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • families who have a child aged 18 months through 5 years
  • live the Guelph area
  • have a parent who can respond to questionnaires in English

Exclusion criteria

  • families who plan to move during the study period
  • children with severe health conditions (such as severe cerebral palsy) that would prohibit them from participating in study activities

Treatment and study plan

Emails and 4 Home Visits

Behavioral

Weekly emails and 4 home visits with health educator

Control

Behavioral

Monthly emails on child health

Emails and 2 home visits

Behavioral

Weekly emails and 2 home visits with health educator

Primary outcomes

  1. change in adiposity

    Time frame: baseline, 6 month follow-up

Secondary outcomes

  1. change in body mass index

    Time frame: baseline, 6-month follow-up

  2. change in waist circumference

    Time frame: baseline, 6-month follow-up

  3. change in frequency of family meals

    Time frame: baseline, 6-month follow-up

  4. change in child's sleep duration

    Time frame: baseline, 6-months

  5. change in child's physical activity

    Time frame: baseline, 6-months

  6. change in child's fruit and vegetable intake

    Time frame: baseline, 6-month follow-up

  7. change in child's sugar-sweetened beverage intake

    Time frame: baseline, 6-month follow-up

  8. change in sedentary behaviour

    Time frame: baseline, 6-month follow-up

  9. change in child's diastolic blood pressure

    Time frame: baseline, 6-month follow-up

  10. change in child's biomarkers of diabetes and cardiovascular disease risk

    Time frame: baseline, 6-month follow-up

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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