Feasibility Study for Prospective Diet and Lifestyle Cohorts in Delhi, Kerala, and Kolkota, India
Condition: Chronic Diseases
MeSH terms: Chronic Disease
Study type: Observational

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
    

Detailed description: 
      Background

      Cancer research in developing countries has not received adequate attention in spite of
      having great potential to improve our understanding of genes and environmental exposures such
      as diet in the etiology of cancer. Specifically, an Indian dietary cohort would substantially
      expand the intake range and variety of different foods and lifestyles that have not been
      adequately explored, e.g., spices, type of oils, lentils, vegetarianism (tied to religion
      rather than healthy life-style ), and types of physical activities. Indians also have
      distinct cancer incidence patterns. Establishing a cohort will allow us to study multiple
      cancer outcomes as well as other disease end-points (e.g., cardiovascular disease and
      diabetes), and it will avoid potential bias resulting from differential recall of past diet
      by subjects, a critical concern in case-control studies that assess nutritional intake. As
      measurement of various biological markers will be an integral component of this study, it
      will be important to collect biological specimens prior to illness and treatment. This is
      particularly important in India as cases may present with late stage disease.

      Because a study of this magnitude and complexity has not been carried out in India, I have
      proposed a pilot study to determine the feasibility of conducting a large cohort study in
      India. The pilot study consists of three parts: 1) evaluation of logistical issues; 2)
      characterization of the diet; and 3) evaluation of issues related to follow-up and end-point
      ascertainment. In Part A of this pilot study there will be 4,000 subjects. This part of the
      study will be evaluated for logistical issues, including questionnaire administration,
      collection, storage, and analysis. Response rates for questionnaires, collection of
      biospecimens and the centers ability to carry out the proposed research will be evaluated as
      well. Part B of the pilot study consists of a characterization of Indian diet to determine
      within- and between-person variability in intake in a subset of 1,400 subjects; an evaluation
      to determine whether Indians can estimate food quantities accurately; assess the degree of
      measurement error in selected nutrients; and ascertain whether using multiple forms of intake
      instruments in combination with biomarkers may categorize intake with less error. In Part C
      of the pilot study, issues related to follow-up and end-point ascertainment in 1200 subjects
      will be evaluated. In addition, an evaluation of the likelihood of cancers and other chronic
      diseases remaining completely undiagnosed owning to lack of access to health care; assess
      movement pattern and traceability of Indian populations; as well as an evaluation of the
      cancer registry coverage and determine whether supplementary activities are required.
    

Keywords: Diet; Pilot; Cohort; Environmental; Chronic Disease