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Feasibility Study for Prospective Diet and Lifestyle Cohorts in Delhi, Kerala, and Kolkota, India
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2009
First Received: June 19, 2006   Last Updated: May 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00341536
  Purpose

This pilot study will examine the potential for health, diet and lifestyle research in Delhi, Kerala, and Kolkota, India. It will: 1) evaluate the adequacy of the existing infrastructure for a large-scale epidemiologic investigation and follow-up; 2) obtain a characterization of the Indian diet; 3) determine study end-points; 4) evaluate the feasibility of collecting and analyzing biologic samples within India; and 5) evaluate the ability of centers to recruit subjects and collect data.

Indian men and women between 35 and 70 years of age who have resided in the study area (Delhi, Kerala, or Kolkota) for at least 1 year may be eligible for this study. Participants will undergo the following tests and procedures:

Part A: Diet and Lifestyle (2 visits)

  • Questionnaires on medical history and treatment practices, including questions on reproductive history
  • Brief medical examination
  • Body measurements, including height, weight, forearm circumference, thighs, hips, stomach, skin thickness of the back and triceps (back of the arms)
  • Blood draw for research, including studies of gene changes that affect the way the body uses nutrients
  • Collection of toenail clippings for research tests
  • Interview about: 1) dietary habits and understanding of the relationship of diet to health; 2) lifestyle, work, and family health; and 3) moving history (how often subject has moved in the past 5 years, addresses of past homes, and plans for future moves)

Part B: Understanding Diet (6 visits)

  • Interview at each visit about food and drink consumed the day before the interview
  • 2 blood draws
  • 24-hour urine collection
  • Physical activity monitor. The subject wears a small device placed on the belt or waist of the pants for a specified time to measure the amount of movement performed.

Part C: Medical Follow-up Patterns (1 visit)

  • Answer questions about medical history, treatment practices, and dietary habits

Condition
Chronic Diseases

MedlinePlus related topics: Coping with Chronic Illness Diets
U.S. FDA Resources
Study Type: Observational
Official Title: A Feasibility Study for a Prospective Cohort in Delhi, India

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 4044
Study Start Date: June 2004
Detailed Description:

AIM: To conduct a pilot study in Delhi to assess the feasibility of establishing a prospective cohort.

Chronic diseases such as cancer, heart diseases, and diabetes, are now important public health issues in India. They share common risk factors.

Emphasis is being placed on understanding the etiology of these diseases. Over the last decade, India has developed an infrastructure conducive to state-of-the-art epidemiologic research studies. Several high-quality population- and hospital-based cancer registries are located throughout the country and also in Delhi. Now, there is a critical mass of epidemiologists, nutritionists, clinicians and statisticians who are committed to studying the etiology of chronic disease.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Once a subject is identified, their eligibility for study participation will be determined based on the following:

Age between 35-70 years.

Use or would consider using certain medical centers/hospitals in the catchment area.

Resided in study area a minimum period of one year.

Must speak Hindi, Punjabi or English.

Female subjects cannot be pregnant.

EXCLUSION CRITERIA:

Children will be excluded from the study.

We will exclude persons with any physical ailments preventing them from study participation, and with recent chronic or other serious diseases or conditions that have made them alter their diet. This is likely to include cancer as well as cardiovascular disease or diabetes and also some infectious conditions.

Participants will be terminated from the study if they move outside of the study area.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00341536

Contacts
Contact: Rashmi Sinha, Ph.D. (301) 496-6426 sinhar@epndce.nci.nih.gov

Locations
India
Initiative for Cardiovascular Health Research in the Developing Countries Recruiting
New Delhi, India
Sub-Investigator: Prof. K. Srinath Reddy            
Regional Cancer Centre Recruiting
Trivandum, India
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 999904219, 04-C-N219
Study First Received: June 19, 2006
Last Updated: May 6, 2009
ClinicalTrials.gov Identifier: NCT00341536     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diet
Pilot
Cohort
Environmental
Chronic Disease

Study placed in the following topic categories:
Chronic Disease

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Chronic Disease

ClinicalTrials.gov processed this record on May 07, 2009