Please select the eligibility criteria that correspond to the clinical trial below.
Title: Guelph Family Health Study: Pilot Study
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.


Options:
A: Inclusion Criteria:

* Healthy, term infants and their mothers
* Infants 2 wks (+/- 2 wk of age)
* Mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based formula
* Mothers must be older than 18 years of age

Exclusion Criteria:

* Infants who were preterm or have medical conditions that interfere with feeding or eating
* Mothers who had gestational diabetes or are diagnosed with a major illness requiring treatment or surgery
* Mothers who will be going back to work full-time before the infant is 4 months old
* Mothers who are allergic to any vegetables
* Subjects will not be excluded because of economic status, gender, race or ethnicity.
B: Inclusion Criteria. Centers must have met the following criteria to be included: (1) have \> 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment. Studies were excluded if they did not meet these criteria.
C: Inclusion Criteria:

* enrolled in daycare centers at Penn State University

Exclusion Criteria:

* food allergies or intolerances
D: 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

Answer: D