Clinical trial NCT00881478: Family Intervention for Obese Children Using Portion Control Strategy for Weight Control
Official title: Family Intervention for Obese Children Using Portion Control Strategy (F.O.C.U.S.) for Weight Control- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Children
Dyslipidemia
Hypertension
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 102
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity in children is a serious disease that is associated with increased mortality and decreased life expectancy. A simple tool used to assist in controlling portions (and therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance and/or loss. The purpose of this study is to assess the efficacy of a family intervention using a portion control tool to help control weight in obese children. The investigators hypothesize that the use of portion control tools by the parents and child will result in a greater decrease in the child's BMI over a 6 month period compared with the control group.

Detailed description: This study is a randomized controlled trial designed to assess the efficacy of a portion control tool to help improve body mass index in obese children over a 6 months period. This study will also assess whether this weight control strategy results in improvement of blood pressure, waist circumference, and biomarkers of obesity including plasma visfatin, adiponectin, fasting lipid profile and apolipoprotein B, liver function tests and fasting insulin and glucose. Both the intervention and the control group will receive a one hour session of standard dietary counseling from a registered dietician at baseline regarding healthy eating habits, appropriate portion sizes and the Canada Food Guide. The duration of this study will be 6 months. Baseline measurements will be taken at the initial visit and again at 3 months and 6 months. Each participants' height and weight will be measured, and BMI will be calculated. Waist circumference and blood pressure will also be measured. A blood sample will be drawn at baseline and 6 months for a fasting lipid profile, fasting insulin, and glucose levels. Measurement of plasma visfatin and adiponectin levels using ELISA will be carried out.

Eligibility criteria: Inclusion Criteria:

* age 8 years old to 16 years old
* BMI greater than or equal to the 85th percentile for age and gender

Exclusion Criteria:

* patients currently taking a weight loss medication
* gastrointestinal disorder
* psychiatric illness under the care of a psychiatrist
* Cushing's syndrome
* hypothalamic or genetic etiology of obesity
* uncontrolled or untreated thyroid disease
* current diagnosis of cancer
* history of an eating disorder such as bulimia or anorexia nervosa
* surgery in the past 3 months
* surgery planned in the ensuing 6 months
* any chronic illness that could affect weight status

Primary outcomes:
measure: Change in age and gender adjusted BMI z-score
timeFrame: 6 months
Secondary outcomes:
measure: Change in age and gender adjusted waist circumference percentile
timeFrame: 6 months
measure: Change in age and gender adjusted blood pressure percentile
timeFrame: 6 months
measure: Change in fasting lipid profile
timeFrame: 6 months
measure: Change in fasting insulin and fasting glucose
timeFrame: 6 months
measure: Change in plasma visfatin level
timeFrame: 6 months
measure: Change in plasma adiponectin level
timeFrame: 6 months
measure: Proportion of children achieving a BMI below the 85th percentile for age and gender
timeFrame: 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Josephine Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen SD, Kang J, Kline GA. Portion control plate for weight loss in obese patients with type 2 diabetes mellitus: a controlled clinical trial. Arch Intern Med. 2007 Jun 25;167(12):1277-83. doi: 10.1001/archinte.167.12.1277.