Nutrition and Physical Activity Counselling

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02637752

Collaborator

(none)

168

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity	Behavioral: Lifestyle counseling or nutrition/physical counselling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Efficacy of Nutrition and Physical Activity Counselling for Pre-adolescent Children in a Dental Setting: A Randomized Clinical Trial

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lifestyle counseling Intervention: Lifestyle counseling or nutrition/physical counselling	Behavioral: Lifestyle counseling or nutrition/physical counselling 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.
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.

Arm

Intervention/Treatment

Active Comparator: Lifestyle counseling

Intervention: Lifestyle counseling or nutrition/physical counselling

Behavioral: Lifestyle counseling or nutrition/physical counselling

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.

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.

Outcome Measures

Primary Outcome Measures

Body Mass Index (BMI) [6-12 months from the baseline]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy
6 to 11 years old

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator: Amir Azarpazhooh, DDS MSc PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amir Azarpazhooh, Dr., University of Toronto

ClinicalTrials.gov Identifier:

NCT02637752

Other Study ID Numbers:

AMAZ 515

First Posted:

Dec 22, 2015

Last Update Posted:

Dec 22, 2015

Last Verified:

Dec 1, 2015

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Amir Azarpazhooh, Dr., University of Toronto

Pediatric Obesity

Body Mass Index

Dentistry

Additional relevant MeSH terms:

Pediatric Obesity

Study Results

No Results Posted as of Dec 22, 2015