NCT00881478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

October 1, 2011

Enrollment Period

5 years

First QC Date

April 13, 2009

Last Update Submit

August 29, 2014

Conditions

Obesity

Keywords

ObesityChildrenDyslipidemiaHypertension

Outcome Measures

Primary Outcomes (1)

  • Change in age and gender adjusted BMI z-score

    6 months

Secondary Outcomes (7)

  • Change in age and gender adjusted waist circumference percentile

    6 months

  • Change in age and gender adjusted blood pressure percentile

    6 months

  • Change in fasting lipid profile

    6 months

  • Change in fasting insulin and fasting glucose

    6 months

  • Change in plasma visfatin level

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Nutrition counselling alone

ACTIVE COMPARATOR

Nutrition counseling session with registered dietician

Other: Nutrition counseling

Nutrition counselling + portion control

EXPERIMENTAL

Nutrition counseling with registered dietician in addition to teaching about use of a portion control tool

Other: Nutrition counseling + portion control tool

Interventions

Nutrition counseling + portion control toolOTHER

Nutrition counseling with registered dietician in addition to teaching about how use of a portion control tool

Nutrition counselling + portion control
Nutrition counselingOTHER

Nutrition counseling with registered dietician

Nutrition counselling alone

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age 8 years old to 16 years old
  • BMI greater than or equal to the 85th percentile for age and gender

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (1)

  • 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. doi: 10.1001/archinte.167.12.1277.

    PMID: 17592101BACKGROUND

MeSH Terms

Conditions

ObesityDyslipidemiasHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Josephine Ho, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Faculty of Medicine

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 15, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 3, 2014

Record last verified: 2011-10

Locations

CA(1)