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Physical Activity and Childhood Obesity

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Obesity

Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Anna Brooke
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

11 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria - Not an applicable clinical trial

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity.
    In this study, physical activity will be measured using a single-plane accelerometer (CSA model 7164) - a small, lightweight electronic motion sensor attached to the child's belt for a period of 5 days. This instrument gives the capacity to to characterize children's physical activity, and inactivity, more accurately than ever before.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2003
    Last Updated
    May 24, 2016
    Sponsor
    Anna Brooke
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00063544
    Brief Title
    Physical Activity and Childhood Obesity
    Official Title
    Physical Activity and Childhood Obesity
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    CI left institution
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    April 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Anna Brooke
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To measure associations between physical activity and obesity in a large, population-based cohort of children.
    Detailed Description
    BACKGROUND: Childhood obesity is rapidly increasing in many countries and environmental factors are the main cause. The onset of puberty may be a critical period. Diet and physical activity are likely to be prime causative factors, although the relative role of each may vary between children of differing age, gender and ethnicity. There are also likely to be many psychosocial and social-demographic factors that can confound these relationships, and these confounders may vary between sub-groups. There continues to be uncertainty regarding the role of these factors and their differential effects in subgroups of the population. It is crucial to develop a better understanding of how dietary and physical activity patterns affect energy balance, and how these characteristics interact with other factors. Measures of physical activity will be added to ongoing assessments of boys and girls (n=10,000) participating in the Avon Longitudinal Study of Parents and Children (ALSPAC). This comprehensive study has been following children and their parents for about 9-10 years. The study has an extensive database including maternal and paternal social background, lifestyle and habits (including diet and physical activity), medical history and medications during pregnancy and thereafter. ALSPAC has also collected and retained biological samples including maternal blood, urine, cord blood, umbilical cord, placenta, hair and nail clippings, deciduous teeth, child's blood and DNA. Data on the mothers also include details of her own parent's lifestyle, her childhood, lifestyle, occupation history and diet, and access to mother's biological samples. Over 71% of the cohort (>10,000 of 14,541 participants) have been retained. DESIGN NARRATIVE: Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity. Physical activity will be measured objectively for 5 days. The data, together with other data collected during pregnancy, infancy and childhood will be used to investigate relationships between modes, intensities, quantities and patterns of physical activity and the development of obesity at this critical stage of life. The strengths of this prospective study are its size, high retention rates and the extensive set of whole-of-life measures already taken on the children. With over 10,000 children expected to attend annually for health checks throughout adolescence, the study will be adequately powered to quantify associations between physical activity and obesity. The study of physical activity in children has to date been seriously restricted because of high levels of measurement error inherent in all self-report measures of physical activity. In this study, physical activity will be measured using a single-plane accelerometer (CSA model 7164) - a small, lightweight electronic motion sensor attached to the child's belt for a period of 5 days. This instrument gives the capacity to to characterize children's physical activity, and inactivity, more accurately than ever before. Comprehensive measurements of diet and body composition (principally Dual-emission X-ray Absorptiometry - DXA) will also be taken at ages 11 and 13 under separate funding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Obesity

    7. Study Design

    Enrollment
    0 (Actual)
    Primary Outcome Measure Information:
    Title
    Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity.
    Description
    In this study, physical activity will be measured using a single-plane accelerometer (CSA model 7164) - a small, lightweight electronic motion sensor attached to the child's belt for a period of 5 days. This instrument gives the capacity to to characterize children's physical activity, and inactivity, more accurately than ever before.
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria - Not an applicable clinical trial
    Study Population Description
    Not an applicable clinical trial
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chris Riddoch
    Organizational Affiliation
    Bristol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Physical Activity and Childhood Obesity

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