At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Feasibility Study for Prospective Cohort in India
In Brief
An observational study for Chronic Diseases. Completed, enrolled 4,044 participants across 1 site.
Detailed 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