Cardiovascular DiseasesNCT00005330
Framingham Children's Study - Food and Exercise Habits in Framingham Study Descendents
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify early childhood determinants of eating and exercise behaviors that relate to cardiovascular disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1985to Apr 2001
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify early childhood determinants of eating and exercise behaviors that relate to cardiovascular disease.
Read the detailed description
BACKGROUND:
While dietary and physical activity habits are known to relate to cardiovascular risk, in 1985 little data were available on factors that influence the development of such behaviors early in life. In 1987, 106 families with 3 to 5 year old children were recruited to take part in the Framingham Children's Study. The children and their parents are direct descendents (4th and 3rd generation, respectively) of participants in the Framingham Heart Study. During the initial grant period, the feasibility of collecting relevant data has been demonstrated. Maintenance of the cohort and acceptance of the monitoring procedures have been excellent, due partly to the fact that the families consider themselves a part of the Framingham Heart Study and take pride in long-term compliance with study procedures.
DESIGN NARRATIVE:
The investigators have been following 100 families who are 3rd and 4th generation descendants of the original Framingham Heart Study cohort. The subjects were age 3-5 years at the onset of the study and were ages 11-14 years in 1996. There has been excellent cohort maintenance with over 90 percent of the original families continuing to participate. The study was renewed in FY 1996 to extend the Framingham Children's Study (FCS) to permit the evaluation of the determinants of change in the child's risk behaviors and other risk factors from early childhood through puberty to mid to late teens, a time when the individual's risk profile should better reflect his/her cardiovascular risk status as an adult.
The FCS is a longitudinal source of data on diet, activity and family and environmental factors in children. By 1996, the investigators had collected extensive dietary data with an average of 32 days of diet records and almost 50 days of electronically monitored physical activity data for each subject. Additional data included psychosocial and anthropometric data on children and their parents. The extension of the FCS allows continued monitoring of eating behaviors and physical activity habits of the children and their parents, as well as the personal environmental and behavioral factors influencing changes in the child's physical activity, diet, blood pressure, lipids and obesity from pre-school into the late teen years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1985
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005330
- Sponsor's protocol ID
- 4148
- Other IDs
- R01HL035653
- Status last verified
- Apr 2002
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Oliveria SA, Ellison RC, Moore LL, Gillman MW, Garrahie EJ, Singer MR. Parent-child relationships in nutrient intake: the Framingham Children's Study. Am J Clin Nutr. 1992 Sep;56(3):593-8. doi: 10.1093/ajcn/56.3.593.
PubMed 1503074Gillman MW, Cupples LA, Moore LL, Ellison RC. Impact of within-person variability on identifying children with hypercholesterolemia: Framingham Children's Study. J Pediatr. 1992 Sep;121(3):342-7. doi: 10.1016/s0022-3476(05)81785-8.
PubMed 1517906Gillman MW, Oliveria SA, Moore LL, Ellison RC. Inverse association of dietary calcium with systolic blood pressure in young children. JAMA. 1992 May 6;267(17):2340-3.
PubMed 1564773Garrahie EJ, Humphrey KF, Witschi JC, Stephenson WP, Ellison RC. The value of debriefing mothers of 3- to 7-year-old children when analyzing children's food diaries. J Am Diet Assoc. 1991 Jun;91(6):710-1. No abstract available.
PubMed 2040786Marmor JK, Oliveria SA, Donahue RP, Garrahie EJ, White MJ, Moore LL, Ellison RC. Factors encouraging cohort maintenance in a longitudinal study. J Clin Epidemiol. 1991;44(6):531-5. doi: 10.1016/0895-4356(91)90216-v.
PubMed 2037857Moore LL, Lombardi DA, White MJ, Campbell JL, Oliveria SA, Ellison RC. Influence of parents' physical activity levels on activity levels of young children. J Pediatr. 1991 Feb;118(2):215-9. doi: 10.1016/s0022-3476(05)80485-8.
PubMed 1993947Ellison RC, Singer MR, Moore LL, Nguyen US, Garrahie EJ, Marmor JK. Current caffeine intake of young children: amount and sources. J Am Diet Assoc. 1995 Jul;95(7):802-4. doi: 10.1016/S0002-8223(95)00222-7. No abstract available.
PubMed 7797813Singer MR, Moore LL, Garrahie EJ, Ellison RC. The tracking of nutrient intake in young children: the Framingham Children's Study. Am J Public Health. 1995 Dec;85(12):1673-7. doi: 10.2105/ajph.85.12.1673.
PubMed 7503343Moore LL, Nguyen US, Rothman KJ, Cupples LA, Ellison RC. Preschool physical activity level and change in body fatness in young children. The Framingham Children's Study. Am J Epidemiol. 1995 Nov 1;142(9):982-8. doi: 10.1093/oxfordjournals.aje.a117747.
PubMed 7572980Hood MY, Moore LL, Sundarajan-Ramamurti A, Singer M, Cupples LA, Ellison RC. Parental eating attitudes and the development of obesity in children. The Framingham Children's Study. Int J Obes Relat Metab Disord. 2000 Oct;24(10):1319-25. doi: 10.1038/sj.ijo.0801396.
PubMed 11093294
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Framingham Children's Study - Food and Exercise Habits in Framingham Study Descendents
- ClinicalTrials.gov ID
- NCT00005330
- Acronym / sponsor ID
- 4148
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1985
- Study completion
- Apr 2001 (actual)
- First posted
- 26 May 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 identify early childhood determinants of eating and exercise behaviors that relate to cardiovascular disease.
Detailed description
BACKGROUND:
While dietary and physical activity habits are known to relate to cardiovascular risk, in 1985 little data were available on factors that influence the development of such behaviors early in life. In 1987, 106 families with 3 to 5 year old children were recruited to take part in the Framingham Children's Study. The children and their parents are direct descendents (4th and 3rd generation, respectively) of participants in the Framingham Heart Study. During the initial grant period, the feasibility of collecting relevant data has been demonstrated. Maintenance of the cohort and acceptance of the monitoring procedures have been excellent, due partly to the fact that the families consider themselves a part of the Framingham Heart Study and take pride in long-term compliance with study procedures.
DESIGN NARRATIVE:
The investigators have been following 100 families who are 3rd and 4th generation descendants of the original Framingham Heart Study cohort. The subjects were age 3-5 years at the onset of the study and were ages 11-14 years in 1996. There has been excellent cohort maintenance with over 90 percent of the original families continuing to participate. The study was renewed in FY 1996 to extend the Framingham Children's Study (FCS) to permit the evaluation of the determinants of change in the child's risk behaviors and other risk factors from early childhood through puberty to mid to late teens, a time when the individual's risk profile should better reflect his/her cardiovascular risk status as an adult.
The FCS is a longitudinal source of data on diet, activity and family and environmental factors in children. By 1996, the investigators had collected extensive dietary data with an average of 32 days of diet records and almost 50 days of electronically monitored physical activity data for each subject. Additional data included psychosocial and anthropometric data on children and their parents. The extension of the FCS allows continued monitoring of eating behaviors and physical activity habits of the children and their parents, as well as the personal environmental and behavioral factors influencing changes in the child's physical activity, diet, blood pressure, lipids and obesity from pre-school into the late teen years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 13 May 2016.
- Background: PubMed 1503074Oliveria SA, Ellison RC, Moore LL, Gillman MW, Garrahie EJ, Singer MR. Parent-child relationships in nutrient intake: the Framingham Children's Study. Am J Clin Nutr. 1992 Sep;56(3):593-8. doi: 10.1093/ajcn/56.3.593.
- Background: PubMed 1517906Gillman MW, Cupples LA, Moore LL, Ellison RC. Impact of within-person variability on identifying children with hypercholesterolemia: Framingham Children's Study. J Pediatr. 1992 Sep;121(3):342-7. doi: 10.1016/s0022-3476(05)81785-8.
- Background: PubMed 1564773Gillman MW, Oliveria SA, Moore LL, Ellison RC. Inverse association of dietary calcium with systolic blood pressure in young children. JAMA. 1992 May 6;267(17):2340-3.
- Background: PubMed 2040786Garrahie EJ, Humphrey KF, Witschi JC, Stephenson WP, Ellison RC. The value of debriefing mothers of 3- to 7-year-old children when analyzing children's food diaries. J Am Diet Assoc. 1991 Jun;91(6):710-1. No abstract available.
- Background: PubMed 2037857Marmor JK, Oliveria SA, Donahue RP, Garrahie EJ, White MJ, Moore LL, Ellison RC. Factors encouraging cohort maintenance in a longitudinal study. J Clin Epidemiol. 1991;44(6):531-5. doi: 10.1016/0895-4356(91)90216-v.
- Background: PubMed 1993947Moore LL, Lombardi DA, White MJ, Campbell JL, Oliveria SA, Ellison RC. Influence of parents' physical activity levels on activity levels of young children. J Pediatr. 1991 Feb;118(2):215-9. doi: 10.1016/s0022-3476(05)80485-8.
- Background: PubMed 7797813Ellison RC, Singer MR, Moore LL, Nguyen US, Garrahie EJ, Marmor JK. Current caffeine intake of young children: amount and sources. J Am Diet Assoc. 1995 Jul;95(7):802-4. doi: 10.1016/S0002-8223(95)00222-7. No abstract available.
- Background: PubMed 7503343Singer MR, Moore LL, Garrahie EJ, Ellison RC. The tracking of nutrient intake in young children: the Framingham Children's Study. Am J Public Health. 1995 Dec;85(12):1673-7. doi: 10.2105/ajph.85.12.1673.
- Background: PubMed 7572980Moore LL, Nguyen US, Rothman KJ, Cupples LA, Ellison RC. Preschool physical activity level and change in body fatness in young children. The Framingham Children's Study. Am J Epidemiol. 1995 Nov 1;142(9):982-8. doi: 10.1093/oxfordjournals.aje.a117747.
- Background: PubMed 11093294Hood MY, Moore LL, Sundarajan-Ramamurti A, Singer M, Cupples LA, Ellison RC. Parental eating attitudes and the development of obesity in children. The Framingham Children's Study. Int J Obes Relat Metab Disord. 2000 Oct;24(10):1319-25. doi: 10.1038/sj.ijo.0801396.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 13 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 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 NCT00005330, which also lists 10 linked publications.
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 13 May 2016.