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Feasibility Study for Prospective Diet and Lifestyle Cohorts in Delhi, Kerala, and Kolkota, India

NCT00341536 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4044

Last updated 2018-04-05

No results posted yet for this study

Summary

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

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Rashmi Sinha, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-17
Completion
2013-11-20

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00341536 on ClinicalTrials.gov