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

NCT00341536 | Completed

• 2 other identifiers: 99990421904-C-N219
• Study Type: observational
• Target: 4,044
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Diseases

Keywords

Diet; Pilot; Cohort; Environmental; Chronic Disease

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Initiative for Cardiovascular Health Research in the Developing Countries

New Delhi, India

Location

Related Publications (3)

• Krishnaswamy K, Polasa K. Diet, nutrition & cancer--the Indian scenario. Indian J Med Res. 1995 Nov;102:200-9.

  PMID: 8675239 BACKGROUND

• Krishnaswamy K, Raghuramulu N. Bioactive phytochemicals with emphasis on dietary practices. Indian J Med Res. 1998 Nov;108:167-81.

  PMID: 9863273 BACKGROUND

• Krishnaswamy K, Goud VK, Sesikeran B, Mukundan MA, Krishna TP. Retardation of experimental tumorigenesis and reduction in DNA adducts by turmeric and curcumin. Nutr Cancer. 1998;30(2):163-6. doi: 10.1080/01635589809514657.

  PMID: 9589436 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rashmi Sinha, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 17, 2004
• Study Completion: November 20, 2013
• Last Updated: April 5, 2018

Record last verified: 2013-11-20

Locations

IN (1)