Clinical trial NCT02223234: Guelph Family Health Study: Pilot Study
Official title: Guelph Family Health Study: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: change in adiposity
timeFrame: baseline, 6 month follow-up
Secondary outcomes:
measure: change in body mass index
timeFrame: baseline, 6-month follow-up
measure: change in waist circumference
timeFrame: baseline, 6-month follow-up
measure: change in frequency of family meals
timeFrame: baseline, 6-month follow-up
measure: change in child's sleep duration
timeFrame: baseline, 6-months
measure: change in child's physical activity
timeFrame: baseline, 6-months
measure: change in child's fruit and vegetable intake
timeFrame: baseline, 6-month follow-up
measure: change in child's sugar-sweetened beverage intake
timeFrame: baseline, 6-month follow-up
measure: change in sedentary behaviour
timeFrame: baseline, 6-month follow-up
measure: change in child's diastolic blood pressure
timeFrame: baseline, 6-month follow-up
measure: change in child's biomarkers of diabetes and cardiovascular disease risk
timeFrame: baseline, 6-month follow-up
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Univeristy of Guelph
state: Ontario
Study officials:
References:
citation: Krystia O, Ambrose T, Darlington G, Ma DWL, Buchholz AC, Haines J; Guelph Family Health Study. A randomized home-based childhood obesity prevention pilot intervention has favourable effects on parental body composition: preliminary evidence from the Guelph Family Health Study. BMC Obes. 2019 Mar 4;6:10. doi: 10.1186/s40608-019-0231-y. eCollection 2019.
citation: Haines J, Douglas S, Mirotta JA, O'Kane C, Breau R, Walton K, Krystia O, Chamoun E, Annis A, Darlington GA, Buchholz AC, Duncan AM, Vallis LA, Spriet LL, Mutch DM, Brauer P, Allen-Vercoe E, Taveras EM, Ma DWL; Guelph Family Health Study. Guelph Family Health Study: pilot study of a home-based obesity prevention intervention. Can J Public Health. 2018 Aug;109(4):549-560. doi: 10.17269/s41997-018-0072-3. Epub 2018 Apr 25.