Cardiovascular DiseasesNCT00063544
Physical Activity and Childhood Obesity
An observational study of Cardiovascular Diseases and Heart Diseases, run by Anna Brooke.
Trial summary
To measure associations between physical activity and obesity in a large, population-based cohort of children. Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Not an applicable clinical trial
No eligibility criteria - Not an applicable clinical trial
About this study
To measure associations between physical activity and obesity in a large, population-based cohort of children.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2003 (estimated)
- Study startMay 2003
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: CI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Brooke
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Anna Brooke, University of Bristol
- Investigators
- Chris Riddoch, Principal investigator, Bristol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063544
- Sponsor's protocol ID
- 1219
- Other IDs
- R01HL071248
- Status last verified
- May 2016
- First submitted
- 30 Jun 2003
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Childhood Obesity
- ClinicalTrials.gov ID
- NCT00063544
- Acronym / sponsor ID
- 1219
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: CI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anna BrookeUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Not an applicable clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity.
Time frame: 5 days
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Riddoch principal investigator
Bristol University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Anna Brooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels and patterns of physical activity will be measured on all children at ages 11 and 13 to assess relationships with measures of obesity. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.