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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Calgary.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Obesity
Other: Nutrition counseling + portion control tool
Other: Nutrition counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Intervention for Obese Children Using Portion Control Strategy (F.O.C.U.S.) for Weight Control- A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 116
Study Start Date: August 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nutrition counselling alone
Nutrition counseling session with registered dietician
Other: Nutrition counseling
Nutrition counseling with registered dietician
Experimental: Nutrition counselling + portion control
Nutrition counseling with registered dietician in addition to teaching about use of a portion control tool
Other: Nutrition counseling + portion control tool
Nutrition counseling with registered dietician in addition to teaching about how use of a portion control tool

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.

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881478

Contacts
Contact: Josephine Ho, MD 403-955-7819 josephine.ho@albertahealthservices.ca

Locations
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Josephine Ho, MD    403-955-7819    josephine.ho@albertahealthservices.ca   
Principal Investigator: Josephine Ho, MD         
Sub-Investigator: Carol Huang, MD         
Sub-Investigator: Sue Pedersen, MD         
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Josephine Ho, MD University of Calgary
  More Information

Publications:
Responsible Party: Josephine Ho, Assistant Professor, Faculty of Medicine, University of Calgary
ClinicalTrials.gov Identifier: NCT00881478     History of Changes
Other Study ID Numbers: E22161
Study First Received: April 13, 2009
Last Updated: October 7, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Obesity
Children
Dyslipidemia
Hypertension

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014