Family Intervention for Obese Children Using Portion Control Strategy for Weight Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nutrition counselling alone

Nutrition counseling session with registered dietician

Group Type ACTIVE_COMPARATOR

Nutrition counseling

Intervention Type OTHER

Nutrition counseling with registered dietician

Nutrition counselling + portion control

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

Group Type EXPERIMENTAL

Nutrition counseling + portion control tool

Intervention Type OTHER

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

Interventions

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Nutrition counseling + portion control tool

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

Intervention Type OTHER

Nutrition counseling

Nutrition counseling with registered dietician

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes