HealthyNCT00615641
Diet, Exercise and Body Fat in 3-5 Year Olds
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 2009
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: We are seeking healthy 3-5 year old children in the greater Little Rock area.
Who may be able to join
- 3-5 year old children
- Full term at birth
- English as primary language
- Weighed at least 5.5# at birth
- Parent or guardian is at least 18 years of age
Who cannot join
- Child has any chronic condition, metabolic disorder, pulmonary disorder, bone disorder, condition that may affect growth, ADD or ADHD
- Child on any medication thought to interfere with study parameters as determined by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Relationship of Dietary Factors and Physical Activity to Body Fat in 3-5 Year Old Children
To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.
- Conditions
- Healthy
- Keywords
- Children, Nutrition, Body Fat, Physical Activity, Diet, Childhood Obesity, Healthy Children
- Medical subject headings
- Motor Activity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 3 year old children | |
| 2 | 4 year old children | |
| 3 | 5 year old children |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, United States Department of Agriculture (USDA), Life Measurement Inc., Texas Woman's University
- Investigators
- Tina Crook, M.S., R.D., Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615641
- Sponsor's protocol ID
- 72850
- Other IDs
- CRIS # 6251-51000-005-03S
- Status last verified
- Feb 2010
- First submitted
- 1 Feb 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Dietary Factors and Physical Activity to Body Fat in 3-5 Year Old Children
- ClinicalTrials.gov ID
- NCT00615641
- Acronym / sponsor ID
- 72850
- Conditions
- Healthy
- Keywords
- Children, Nutrition, Body Fat, Physical Activity, Diet, Childhood Obesity, Healthy Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Arkansas, United States Department of Agriculture (USDA), Life Measurement Inc., Texas Woman's University
- Study start
- Jun 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Feb 2008 (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 determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –3 year old children |
| 2 | – | –4 year old children |
| 3 | – | –5 year old children |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We are seeking healthy 3-5 year old children in the greater Little Rock area.
Key inclusion criteria (5 listed)
- 3-5 year old children
- Full term at birth
- English as primary language
- Weighed at least 5.5# at birth
- Parent or guardian is at least 18 years of age
Key exclusion criteria (2 listed)
- Child has any chronic condition, metabolic disorder, pulmonary disorder, bone disorder, condition that may affect growth, ADD or ADHD
- Child on any medication thought to interfere with study parameters as determined by the investigator
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
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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.
Tina Crook, M.S., R.D. principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 17 Feb 2010.