Cardiovascular DiseasesNCT00006307
Epidemiology of Body Mass Index Rebound
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2000to Jul 2006
- 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 7 years
- All sexes
- No healthy volunteers
- Child
No eligibility criteria
About this study
To investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study.
Read the detailed description
BACKGROUND:
Obesity is the most prevalent nutritional problem in the United States. It appears that both the prevalence and severity of obesity have been increasing in recent years. Obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to treatment. This places a premium on prevention. However, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. Recently, it has been shown that the timing of body mass index (BMI) rebound may be a predictor of future obesity. BMI increases during the first year of life. It then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown that BMI rebound at a young age is associated with increased risk of obesity later in life. Currently, very little is known about the epidemiology of BMI rebound.
DESIGN NARRATIVE:
The investigation is a cohort study designed to follow 320 children from age three to age seven years. The study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. Parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2000 (estimated)
- Study startAug 2000
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen Daniels, Children's Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006307
- Sponsor's protocol ID
- 915
- Other IDs
- R01HL064022
- Status last verified
- Jan 2008
- First submitted
- 28 Sep 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Burdette HL, Whitaker RC, Daniels SR. Parental report of outdoor playtime as a measure of physical activity in preschool-aged children. Arch Pediatr Adolesc Med. 2004 Apr;158(4):353-7. doi: 10.1001/archpedi.158.4.353.
PubMed 15066875
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Body Mass Index Rebound
- ClinicalTrials.gov ID
- NCT00006307
- Acronym / sponsor ID
- 915
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 2000
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 29 Sep 2000 (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 investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study.
Detailed description
BACKGROUND:
Obesity is the most prevalent nutritional problem in the United States. It appears that both the prevalence and severity of obesity have been increasing in recent years. Obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to treatment. This places a premium on prevention. However, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. Recently, it has been shown that the timing of body mass index (BMI) rebound may be a predictor of future obesity. BMI increases during the first year of life. It then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown that BMI rebound at a young age is associated with increased risk of obesity later in life. Currently, very little is known about the epidemiology of BMI rebound.
DESIGN NARRATIVE:
The investigation is a cohort study designed to follow 320 children from age three to age seven years. The study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. Parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake.
Study design
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 18 Feb 2016.
- Background: PubMed 15066875Burdette HL, Whitaker RC, Daniels SR. Parental report of outdoor playtime as a measure of physical activity in preschool-aged children. Arch Pediatr Adolesc Med. 2004 Apr;158(4):353-7. doi: 10.1001/archpedi.158.4.353.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Stephen Daniels
Children's Hospital & Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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: finished, as of the sponsor's last update on 18 Feb 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 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?
On the ClinicalTrials.gov record for NCT00006307, which also lists 1 linked publication.
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 18 Feb 2016.