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

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Children, Dyslipidemia, Hypertension
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
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
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
background
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Family Intervention for Obese Children Using Portion Control Strategy for Weight Control
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