Guelph Family Health Study: Pilot Study

Obesity Clinical Trial

Official title:

Guelph Family Health Study: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223234
• Other study ID #: 14AP008
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: January 3, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Emails and 4 Home Visits
Weekly emails and 4 home visits with health educator
• Control
Monthly emails on child health
• Emails and 2 home visits
Weekly emails and 2 home visits with health educator

Locations

Country	Name	City	State
Canada	Univeristy of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in adiposity		baseline, 6 month follow-up	No
Secondary	change in body mass index		baseline, 6-month follow-up	No
Secondary	change in waist circumference		baseline, 6-month follow-up	No
Secondary	change in frequency of family meals		baseline, 6-month follow-up	No
Secondary	change in child's sleep duration		baseline, 6-months	No
Secondary	change in child's physical activity		baseline, 6-months	No
Secondary	change in child's fruit and vegetable intake		baseline, 6-month follow-up	No
Secondary	change in child's sugar-sweetened beverage intake		baseline, 6-month follow-up	No
Secondary	change in sedentary behaviour		baseline, 6-month follow-up	No
Secondary	change in child's diastolic blood pressure		baseline, 6-month follow-up	No
Secondary	change in child's biomarkers of diabetes and cardiovascular disease risk		baseline, 6-month follow-up	No