Guelph Family Health Study: Pilot Study

University of Guelph

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Control; Behavioral: Emails and 2 home visits; Behavioral: Emails and 4 Home Visits

Study type: Interventional

Funder types: Other

Identifiers

NCT02223234

14AP008

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 3 patient groups

Control

Active Comparator group

Description:

Control- monthly mailed information on children's health

Treatment:

Behavioral: Control

Email and 4 Home Visits

Experimental group

Description:

Weekly emails and 4 home visits with a health educator

Treatment:

Behavioral: Emails and 4 Home Visits

Email and 2 Home Visits

Experimental group

Description:

Weekly emails and 2 home visits

Treatment:

Behavioral: Emails and 2 home visits