Family Intervention for Obese Children Using Portion Control Strategy for Weight Control (FOCUS)
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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 |
- Change in age and gender adjusted BMI z-score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Josephine Ho, MD | 403-955-7819 | josephine.ho@albertahealthservices.ca |
| 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 | |
| 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 May 23, 2013