NCT00521651

Brief Summary

This protocol is a sub-study of the ongoing "Protect Health and Reduce Cancer Risk" study conducted in Shanghai, China, and sponsored by the Shanghai Cancer Institute, Vanderbilt University, and the National Cancer Institute. The parent study is designed to examine the relationship of diet, lifestyle, occupational, and environmental risk factors, as well as genetic variation, to cancer incidence in a large cohort of men in women between 40 and 70 years of age. The current sub-study will assess the validity and reliability of a new physical activity questionnaire for use in the parent study and to evaluate whether different types of activity and the frequency, intensity, and duration of activity are associated with markers that have been linked to cancer risk, such as C-reactive protein, interleukin 6 and soluble tumor necrosis factor alpha. Participants in the current 12-month study are selected from among men and women participating in the "Protect Health and Reduce Cancer Risk" study. Participants keep a diary of their physical activity and complete two 30-minute interviews about their physical activity, one at the beginning and one at the end of the study period. Every 3 months for 7 consecutive days, they wear a pager-sized activity monitor on their waist that records their physical activity patterns during that period of time. They provide blood and urine samples four times during the study and, at the end of the study, undergo a health examination that includes an electrocardiogram, body composition measurement, and physical fitness test. The fitness test is a step-test consisting of 3-minute stages in which the subject successively increases the stepping speed until reaching 85 percent of his or her predicted maximal heart rate. Blood and urine samples are analyzed for levels of nutrients and certain proteins, and are stored for future studies related to nutrition and physical activity and possibly for genetic studies related to health, nutrition, exercise, or disease.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2009

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

3.7 years

First QC Date

August 25, 2007

Last Update Submit

September 8, 2020

Conditions

Cancer

Keywords

Physical ActivityCancer Risk

Outcome Measures

Primary Outcomes (1)

  • Physical activity behaviors and circulating or excreted biomarkers

    Biomarkers

    1 Year

Study Arms (1)

Community Cohort

Men and Women from two Shanghai cohort studies.

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may not qualify if:

  • There wil be no prior from participation, other than the presence of physical ailments preventing subjects from participating in the study. Before participating in the fitness test, subjects will be screened for cardiovascular disease, othopedic limitations, or other factors that contraindicate testing, including pregnancy, respiratory problems at rest (labored breathing or persistent cough), presence of illness or fever, or swelling of the lower extremities. In addition, participants who do not adhere to the pre-test instructions of not eating heavily or drinking alcohol 2 hours before the test will be excluded from performing the fitness test.
  • Children will not be included in the current study, because study subjects are comprised of participants in the Shanghai Womens's Cohort Study and the Shanghai Men's Cohort Study, who are 40 to 70 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Shanghai National Cancer Institute

Shanghai, China

Location

Related Publications (3)

  • McTiernan A, Ulrich C, Slate S, Potter J. Physical activity and cancer etiology: associations and mechanisms. Cancer Causes Control. 1998 Oct;9(5):487-509. doi: 10.1023/a:1008853601471.

    PMID: 9934715BACKGROUND

  • Friedenreich CM. Physical activity and cancer prevention: from observational to intervention research. Cancer Epidemiol Biomarkers Prev. 2001 Apr;10(4):287-301.

    PMID: 11319168BACKGROUND

  • Popkin BM. The nutrition transition and obesity in the developing world. J Nutr. 2001 Mar;131(3):871S-873S. doi: 10.1093/jn/131.3.871S.

    PMID: 11238777BACKGROUND

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Charles E Matthews, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2007

First Posted

August 28, 2007

Study Start

August 1, 2005

Primary Completion

April 23, 2009

Study Completion

April 23, 2009

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)CN(1)