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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
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Pediatric Obesity, Body Mass Index, Dentistry

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 14, 2015
    Last Updated
    December 18, 2015
    Sponsor
    University of Toronto
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    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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