Framingham Children's Study - Food and Exercise Habits in Framingham Study Descendents

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To identify early childhood determinants of eating and exercise behaviors that relate to cardiovascular disease.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1985

Study Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

April 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4148
  • R01HL035653 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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