Family Intervention for Obese Children Using Portion Control Strategy for Weight Control - Full Text View

Sponsored by:	University of Calgary
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00881478

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 counselling + portion control tool Other: Nutrition counselling

MedlinePlus related topics: Obesity Obesity in Children

U.S. FDA Resources

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

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 95th percentile for age and gender [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	116
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nutrition counselling alone: Active Comparator Nutrition counselling session with registered dietician	Other: Nutrition counselling Nutrition counselling with registered dietician
Nutrition counselling + portion control: Experimental Nutrition counselling with registered dietician in addition to teaching about use of a portion control tool	Other: Nutrition counselling + portion control tool Nutrition counselling 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 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age 8 yrs to 12 yrs
BMI greater than or equal to the 95th 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

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

Contacts

Contact: Josephine Ho, MD

403-955-7819

josephine.ho@calgaryhealthregion.ca

Locations

Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8

Sponsors and Collaborators

University of Calgary

Investigators

Principal Investigator:

Josephine Ho, MD

University of Calgary

More Information

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.

Responsible Party:	University of Calgary ( Dr. Josephine Ho )
Study ID Numbers:	E22161
Study First Received:	April 13, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881478 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Calgary:

Obesity
Children
Dyslipidemia
Hypertension

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Dyslipidemias
Hypertension

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009