Nutrition and Physical Activity Counselling
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle counseling or nutrition/physical counselling
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Pediatric Obesity, Body Mass Index, Dentistry
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifestyle counseling
No Intervention
Arm Description
Intervention: Lifestyle counseling or nutrition/physical counselling
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 Outcome Measures
Body Mass Index (BMI)
Secondary Outcome Measures
physical activity (hrs/day)
screen time (hrs/day)
number of sugar-sweetened beverages consumed per day
Full Information
NCT ID
NCT02637752
First Posted
December 14, 2015
Last Updated
December 18, 2015
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02637752
Brief Title
Nutrition and Physical Activity Counselling
Official Title
Efficacy of Nutrition and Physical Activity Counselling for Pre-adolescent Children in a Dental Setting: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Pediatric Obesity, Body Mass Index, Dentistry
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
Intervention: Lifestyle counseling or nutrition/physical counselling
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling or nutrition/physical counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
6-12 months from the baseline
Secondary Outcome Measure Information:
Title
physical activity (hrs/day)
Time Frame
6-12 months
Title
screen time (hrs/day)
Time Frame
6-12 months
Title
number of sugar-sweetened beverages consumed per day
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Azarpazhooh, DDS MSc PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28212686
Citation
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.
Results Reference
derived
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Nutrition and Physical Activity Counselling
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