Home-Based Measures of Physical Activity and Body Composition

Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Physical Activity Recall; Behavioral: Environmental Assessments

Detailed Description

SCREENING PHONE CALL:

If you are interested in taking part in this study, the study staff will contact you by phone and you will answer questions about your physical ability to exercise. Based on the answers you give, the study doctor will decide if you are eligible to participate. The phone call will last about 10-15 minutes.

STUDY PROCEDURES:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to complete physical activity recall and environmental assessments on a palm pilot either 3 times a day or once a day. For the physical activity recall assessment, you will describe what types of physical activity you did that day. The environmental assessments will be to describe your current location or environment. It should take less than 5 minutes to complete each assessment.

Visit 1:

You will come to the M. D. Anderson Behavioral Research and Treatment Center for 2 visits. At the first visit, the following tests and procedures will be performed:

• Your height and weight will be measured.
• You will complete a questionnaire about your health, your neighborhood, and your physical activity. The questionnaire will take about 30 minutes to complete.
• You will walk on a treadmill while your heart rate, blood pressure, and respiration (breathing) are monitored. You will walk until you feel fatigued.

The research staff will then give you instructions for the tests you will do at home. This visit will last about 120 minutes.

At Home Activities:

During the next week, you will wear a pedometer and an actigraph. These are small devices that you wear on your waist during the day from the time you get up in the morning to when you go to bed at night. You will not wear the devices in water. These devices will record how active you are.

You will answer questions on a handheld computer 5-7 times each day. These questions will ask about your physical activity and about how your environment may encourage or discourage physical activity. It will take between 30 seconds and 3 minutes to answer the questions each time.

You will measure the distance around your waist and hips (circumference). You will do a fitness test that involves stepping up and down on a small stool for 3 minutes. You will take your heart rate after the stool-stepping exercise. The study staff will give you all the equipment and supplies needed for these tests at the first visit, and you will be asked to return the equipment at the second visit.

Visit 2:

Seven (7) days after the first visit, you will return to M. D. Anderson for the second visit. The following tests and procedures will be performed:

• You will perform the stool-stepping test.
• You will have your waist and hip circumference measured.
• You will be asked about your physical activity over the past week.

This visit will take about 60 minutes.

LENGTH OF STUDY:

You will be off-study once you complete Visit 2.

This is an investigational study. Up to 75 individuals will take part in the study. All will be enrolled at M. D. Anderson.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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)
2. speaks English
3. able to give informed consent
4. no previous cancer diagnosis

Exclusion Criteria:

1. pregnant women
2. children under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Activity Recall; 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; 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.
Active Comparator: Environmental Assessment; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen Basen-Engquist, PhD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2007
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 10, 2007
• First Submitted That Met QC Criteria: October 10, 2007
• First Posted (Estimated): October 11, 2007

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Cardiovascular Disease; Body Composition; Environment; Cancer Prevention
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2007-0278; NCI-2011-02917 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No