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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutrition counseling + portion control tool
Nutrition counseling
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Children, Dyslipidemia, Hypertension

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts 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

Sites / Locations

  • Alberta Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nutrition counselling alone

Nutrition counselling + portion control

Arm Description

Nutrition counseling session with registered dietician

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

Outcomes

Primary Outcome Measures

Change in age and gender adjusted BMI z-score

Secondary Outcome Measures

Change in age and gender adjusted waist circumference percentile
Change in age and gender adjusted blood pressure percentile
Change in fasting lipid profile
Change in fasting insulin and fasting glucose
Change in plasma visfatin level
Change in plasma adiponectin level
Proportion of children achieving a BMI below the 85th percentile for age and gender

Full Information

First Posted
April 13, 2009
Last Updated
August 29, 2014
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00881478
Brief Title
Family Intervention for Obese Children Using Portion Control Strategy for Weight Control
Acronym
FOCUS
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Children, Dyslipidemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition counselling alone
Arm Type
Active Comparator
Arm Description
Nutrition counseling session with registered dietician
Arm Title
Nutrition counselling + portion control
Arm Type
Experimental
Arm Description
Nutrition counseling with registered dietician in addition to teaching about use of a portion control tool
Intervention Type
Other
Intervention Name(s)
Nutrition counseling + portion control tool
Intervention Description
Nutrition counseling with registered dietician in addition to teaching about how use of a portion control tool
Intervention Type
Other
Intervention Name(s)
Nutrition counseling
Intervention Description
Nutrition counseling with registered dietician
Primary Outcome Measure Information:
Title
Change in age and gender adjusted BMI z-score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in age and gender adjusted waist circumference percentile
Time Frame
6 months
Title
Change in age and gender adjusted blood pressure percentile
Time Frame
6 months
Title
Change in fasting lipid profile
Time Frame
6 months
Title
Change in fasting insulin and fasting glucose
Time Frame
6 months
Title
Change in plasma visfatin level
Time Frame
6 months
Title
Change in plasma adiponectin level
Time Frame
6 months
Title
Proportion of children achieving a BMI below the 85th percentile for age and gender
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josephine Ho, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17592101
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.
Results Reference
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Family Intervention for Obese Children Using Portion Control Strategy for Weight Control

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