NCT02637752

Brief Summary

Background: Childhood obesity imposes a great burden on the healthcare system. Given the increased frequency of dental compared to medical visits during childhood, dentists may be in an ideal position to recognize patients at risk of developing obesity. This randomized clinical trial explored the efficacy of a brief nutrition and physical activity counseling for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic. Methods: 168 children, 6-11 year old, were allocated to test and control groups and their Body Mass index (BMI) were recorded. Their parents/caregivers completed a questionnaire regarding their child's nutrition, physical activity and screen time. The parents/caregivers of the test group then received a brief counseling session that encouraged an increase in children's physical activity, and a decrease in sugar-sweetened beverages and screen time. Data, collected at baseline and follow-up session (within 6-12 months) were analyzed using general linear regression, adjusting for age, gender, socio-demographic characteristics, education, labour force, income and awareness of school nutrition policy (P≤ 0.05).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

December 14, 2015

Last Update Submit

December 18, 2015

Conditions

Childhood Obesity

Keywords

Pediatric ObesityBody Mass IndexDentistry

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    6-12 months from the baseline

Secondary Outcomes (3)

  • physical activity (hrs/day)

    6-12 months

  • screen time (hrs/day)

    6-12 months

  • number of sugar-sweetened beverages consumed per day

    6-12 months

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

Intervention: Lifestyle counseling or nutrition/physical counselling

Behavioral: Lifestyle counseling or nutrition/physical counselling

No Intervention

NO INTERVENTION

To ensure that both groups benefited equally from the study, the control group received the counselling and the handouts at the end of the study.

Interventions

Lifestyle counseling or nutrition/physical counsellingBEHAVIORAL

A brief (5-10 minute) counseling session for caregivers of the intervention group aimed to encourage an increase in the child's physical activity and decrease sugar-sweetened beverage consumption and screen time. Additionally, the caregivers of the intervention group were provided with the following handouts: five steps to a healthy body weight for teens; beverages; physical activity tips for children 5-11 years; Canadian physical activity guidelines for children 5-11; and Canadian sedentary behavior guidelines for children 5-11.

Lifestyle counseling

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy
  • to 11 years old

You may not qualify if:

  • Younger or older children
  • those with systemic diseases (such as diabetes, cardiac problems, dyslipidemia, elevated cholesterol, obstructive sleep apnea, stroke, fatty liver disease, osteoarthritis, orthopedic problems and any forms of cancer)
  • Children and their accompanying parents or caregivers (hereafter, caregivers) unable to communicate in English
  • if caregivers were unreachable after three attempts by phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Azarpazhooh A, Sekhavat A, Sigal MJ. Validity of a simplified screening instrument for assessing overweight children in a dental setting: a cross sectional study. BMC Pediatr. 2017 Feb 17;17(1):56. doi: 10.1186/s12887-017-0808-x.

    PMID: 28212686DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Amir Azarpazhooh, DDS MSc PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 22, 2015

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 22, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share