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

This study is currently recruiting participants.

Verified October 2011 by University of Calgary

Sponsor:

Information provided by (Responsible Party):

Josephine Ho, University of Calgary

ClinicalTrials.gov Identifier:

NCT00881478

First received: April 13, 2009

Last updated: October 7, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 13, 2009

Last Updated Date

October 7, 2011

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in age and gender adjusted BMI z-score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00881478 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in age and gender adjusted waist circumference percentile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in age and gender adjusted blood pressure percentile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in fasting lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in fasting insulin and fasting glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in plasma visfatin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in plasma adiponectin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of children achieving a BMI below the 85th percentile for age and gender [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in age and gender adjusted waist circumference percentile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in age and gender adjusted blood pressure percentile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in fasting lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in fasting insulin and fasting glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in plasma visfatin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in plasma adiponectin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of children achieving a BMI below the 95th percentile for age and gender [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Family Intervention for Obese Children Using Portion Control Strategy (F.O.C.U.S.) for Weight Control- A Randomized Controlled Trial

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Nutrition counselling alone
Nutrition counseling session with registered dietician

Intervention: Other: Nutrition counseling
Experimental: Nutrition counselling + portion control
Nutrition counseling with registered dietician in addition to teaching about use of a portion control tool

Intervention: Other: Nutrition counseling + portion control tool

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

116

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 16 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Josephine Ho, MD

403-955-7819

josephine.ho@albertahealthservices.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00881478

Other Study ID Numbers ^ICMJE

E22161

Has Data Monitoring Committee

Responsible Party

Josephine Ho, University of Calgary

Study Sponsor ^ICMJE

University of Calgary

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Josephine Ho, MD

University of Calgary

Information Provided By

University of Calgary

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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