Chronic Diseases Clinical Trial
Official title:
A Feasibility Study for Prospective Cohort in India
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
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02694796 -
Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy
|
N/A | |
Completed |
NCT02351648 -
A Randomised Control Trial of a Transitional Care Model in Singapore General Hospital
|
N/A | |
Completed |
NCT00772733 -
A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment
|
N/A | |
Completed |
NCT00126737 -
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
|
N/A | |
Completed |
NCT01719991 -
Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support
|
N/A | |
Completed |
NCT00569595 -
Improving Health Habits in Impoverished Populations
|
Phase 3 | |
Completed |
NCT00309296 -
Longitudinal Care: Smoking Reduction to Aid Cessation
|
N/A | |
Completed |
NCT02487589 -
Falls in Elderly and Telehealth: a Randomized Controlled Study
|
N/A | |
Recruiting |
NCT00172926 -
Study on the Relationship Between Physical Constitution and Diseases
|
N/A | |
Completed |
NCT00222703 -
Enhancing Tobacco Abstinence Following Hospitalization
|
N/A | |
Recruiting |
NCT05233917 -
Dietary Metabolic Signatures in Health Study
|
||
Active, not recruiting |
NCT05247632 -
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study
|
||
Completed |
NCT02885129 -
Development of the General Scale Observance for Chronic Diseases
|
N/A | |
Completed |
NCT01832064 -
Active Living Tool Kit for Chronic Conditions
|
N/A | |
Completed |
NCT01625468 -
Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households
|
N/A | |
Not yet recruiting |
NCT06046326 -
Evaluate the Effectiveness of a Virtual Community of Practice
|
N/A | |
Completed |
NCT06179238 -
Urinary Catheter Self-care Management
|
N/A | |
Active, not recruiting |
NCT02637869 -
Evaluating Community Health Centers' Adoption of a New Global Capitation Payment
|
||
Completed |
NCT02191111 -
A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies
|
N/A | |
Completed |
NCT01372137 -
First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94
|
Phase 1 |