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

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ClinicalTrials.gov Identifier: NCT00881478
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Josephine Ho, University of Calgary

April 13, 2009
April 15, 2009
September 3, 2014
August 2009
August 2014   (Final data collection date for primary outcome measure)
Change in age and gender adjusted BMI z-score [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00881478 on ClinicalTrials.gov Archive Site
  • Change in age and gender adjusted waist circumference percentile [ Time Frame: 6 months ]
  • Change in age and gender adjusted blood pressure percentile [ Time Frame: 6 months ]
  • Change in fasting lipid profile [ Time Frame: 6 months ]
  • Change in fasting insulin and fasting glucose [ Time Frame: 6 months ]
  • Change in plasma visfatin level [ Time Frame: 6 months ]
  • Change in plasma adiponectin level [ Time Frame: 6 months ]
  • Proportion of children achieving a BMI below the 85th percentile for age and gender [ Time Frame: 6 months ]
  • Change in age and gender adjusted waist circumference percentile [ Time Frame: 6 months ]
  • Change in age and gender adjusted blood pressure percentile [ Time Frame: 6 months ]
  • Change in fasting lipid profile [ Time Frame: 6 months ]
  • Change in fasting insulin and fasting glucose [ Time Frame: 6 months ]
  • Change in plasma visfatin level [ Time Frame: 6 months ]
  • Change in plasma adiponectin level [ Time Frame: 6 months ]
  • Proportion of children achieving a BMI below the 95th percentile for age and gender [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Family Intervention for Obese Children Using Portion Control Strategy for Weight Control
Family Intervention for Obese Children Using Portion Control Strategy (F.O.C.U.S.) for Weight Control- A Randomized Controlled Trial
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • 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
  • 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
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.
 
Completed
102
August 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 16 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00881478
E22161
No
Not Provided
Not Provided
Josephine Ho, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Josephine Ho, MD University of Calgary
University of Calgary
October 2011

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