Family Intervention for Obese Children Using Portion Control Strategy for Weight Control (FOCUS)

University of Calgary

Status: Completed

Conditions: Obesity

Treatments: Other: Nutrition counseling + portion control tool; Other: Nutrition counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00881478

E22161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Nutrition counselling alone

Active Comparator group

Description:

Nutrition counseling session with registered dietician

Treatment:

Other: Nutrition counseling

Nutrition counselling + portion control

Experimental group

Description:

Nutrition counseling with registered dietician in addition to teaching about use of a portion control tool

Treatment:

Other: Nutrition counseling + portion control tool