FOCUS: Family Intervention for Obese Children Using Portion Control Strategy for Weight Control

• Sponsor: University of Calgary (Other)
• Overall Status: Completed
• CT.gov ID: NCT00881478
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Nutrition counseling + portion control tool; Other: Nutrition counseling	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in age and gender adjusted BMI z-score [6 months]

Secondary Outcome Measures

1. Change in age and gender adjusted waist circumference percentile [6 months]

2. Change in age and gender adjusted blood pressure percentile [6 months]

3. Change in fasting lipid profile [6 months]

4. Change in fasting insulin and fasting glucose [6 months]

5. Change in plasma visfatin level [6 months]

6. Change in plasma adiponectin level [6 months]

7. Proportion of children achieving a BMI below the 85th percentile for age and gender [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 16 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Alberta Children's Hospital	Calgary	Alberta	Canada	T3B 6A8

Sponsors and Collaborators

• University of Calgary

Investigators

• Principal Investigator: Josephine Ho, MD, University of Calgary

Study Documents (Full-Text)

None provided.

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: Josephine Ho, Assistant Professor, Faculty of Medicine, University of Calgary
• ClinicalTrials.gov Identifier: NCT00881478
• Other Study ID Numbers: E22161
• First Posted: Apr 15, 2009
• Last Update Posted: Sep 3, 2014
• Last Verified: Oct 1, 2011

• Keywords provided by Josephine Ho, Assistant Professor, Faculty of Medicine, University of Calgary: Obesity; Children; Dyslipidemia; Hypertension
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Sep 3, 2014