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Clinical Trials/NCT02637752
NCT02637752CompletedNot Applicable

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

University of Toronto0 sites168 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
168
Primary Endpoint
Body Mass Index (BMI)

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

Lifestyle counseling

Active Comparator

Intervention: Lifestyle counseling or nutrition/physical counselling

Intervention: Lifestyle counseling or nutrition/physical counselling (Behavioral)

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.

Outcomes

Primary Outcomes

Body Mass Index (BMI)

Time Frame: 6-12 months from the baseline

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amir Azarpazhooh

Dr.

University of Toronto

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