NCT00542438

Brief Summary

The specific aim of this study is to collect preliminary data on the feasibility and validity of home-based data collection methods to measure four constructs:

  • Physical Activity: Real-time assessment using Ecological Momentary Assessment (EMA) and pedometers
  • Cardiorespiratory Fitness: Step test
  • Anthropometry: Waist and hip circumference measurements
  • Environmental Variables: Examples include density of neighborhood physical activity facilities (including gyms, parks, walking trails), crime, land use mix, and transportation variables, collected by participants using EMA.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 9, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
18.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

18.7 years

First QC Date

October 10, 2007

Last Update Submit

January 13, 2026

Conditions

Cardiovascular Disease

Keywords

Cardiovascular DiseaseCancer PreventionPhysical ActivityBody CompositionEnvironmentExercise

Outcome Measures

Primary Outcomes (1)

  • Feasibility of home-based data collection methods: Percentage of Participants Completing Step Test

    Feasibility measured by the percentage of participants who have adequate cardiorespiratory fitness (i.e., V02 max greater than or equal to 31) to perform the step test. Researchers will consider the test feasible if greater than or equal to 75% of the participants have adequate fitness to perform the test.

    3 Years

Study Arms (2)

Physical Activity Recall

ACTIVE COMPARATOR

Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.

Behavioral: Physical Activity Recall

Environmental Assessment

ACTIVE COMPARATOR

Environmental assessments on a palm pilot either 3 times a day or once a day. Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).

Behavioral: Environmental Assessments

Interventions

Physical Activity RecallBEHAVIORAL

Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.

Physical Activity Recall
Environmental AssessmentsBEHAVIORAL

Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).

Environmental Assessment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • low-risk for cardiovascular disease, as defined by the American College of Sports Medicine (under 45 years of age for men and under 55 years of age for women, and less than two cardiovascular risk factors)
  • speaks English
  • able to give informed consent
  • no previous cancer diagnosis

You may not qualify if:

  • pregnant women
  • children under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Karen Basen-Engquist, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 11, 2007

Study Start

October 9, 2007

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

US(1)