Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT01294657
Status:
UNKNOWN
Last Update Posted:
2019-05-10
First Post:
2011-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obesity: Cancer Risk Among African Americans
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Obesity: Cancer Risk Among African Americans-Developing Interventions Through Community Collaboration
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to learn if a motivation and problem solving (MAPS) program can help improve diet and levels of physical activity in African Americans who are overweight.
Detailed Description:
Day 1 Study Visit:
If you are found eligible to take part in this study, the following tests and procedures will be performed on Day 1 (the same day you complete the screening tests and sign this consent form):
* You will complete a computer-based survey about your mood, diet, and physical activity. The survey should take about 90 minutes total to complete.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
* Your non-fasting blood glucose and cholesterol levels will be measured (with 2 small finger pricks).
* You will be asked to provide a 7-day record of your physical activity using a small device called an accelerometer. The accelerometer will be worn on your hip and measures the amount of physical activity you do. You will be given a prepaid envelope to return the accelerometer to the study staff.
Study Groups and Study Procedures:
At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups.
If you are in Group 1 or 2, you will receive health education on Day 1, 6 months, and 12 months later. Health education includes:
* A brief counseling session with a study staff member to talk about diet and your physical activity levels
* Referrals to available resources for help with your diet and physical activity
* Self-help materials that are designed to help you learn how to improve your diet and physical activity
At Months 6 and 12, you will also:
* Complete the computer-based survey about your mood, diet, and physical activity.
* Have your height, weight, waistline and blood pressure measured.
* Your non-fasting blood glucose and cholesterol levels will be measured.
* Be given an accelerometer to wear for 7 days.You will be given a prepaid envelope to return the accelerometer to the study staff.
If you are in Group 2, you will also take part in the MAPS program. For the MAPS program, you will have 12 counseling phone calls over 1 year. Each of these phone calls will be digitally recorded and should last about 20-30 minutes. You may decline to have your counseling phone call recorded if it makes you feel uncomfortable. The purpose of the phone calls are to provide support to you on changes in your diet or physical activity and to answer any questions you may have about your program.
Length of Study:
You will remain on the study for up to 1 year. Your participation on this study will be over once you complete the study visit at Month 12.
Other Important Information:
You may be contacted by phone, mail, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information for family members and/or friends for the study staff to contact in the event there is trouble reaching you first.
If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away.
All participant's paper files will be stored in locked file cabinets and all data files will be stored in a password-protected databases. The information discussed during the counseling phone calls will be kept confidential. Only members of the research team will have access to the recordings.
This is an investigational study.
Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
If you are found eligible to take part in this study, the following tests and procedures will be performed on Day 1 (the same day you complete the screening tests and sign this consent form):
* You will complete a computer-based survey about your mood, diet, and physical activity. The survey should take about 90 minutes total to complete.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
* Your non-fasting blood glucose and cholesterol levels will be measured (with 2 small finger pricks).
* You will be asked to provide a 7-day record of your physical activity using a small device called an accelerometer. The accelerometer will be worn on your hip and measures the amount of physical activity you do. You will be given a prepaid envelope to return the accelerometer to the study staff.
Study Groups and Study Procedures:
At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups.
If you are in Group 1 or 2, you will receive health education on Day 1, 6 months, and 12 months later. Health education includes:
* A brief counseling session with a study staff member to talk about diet and your physical activity levels
* Referrals to available resources for help with your diet and physical activity
* Self-help materials that are designed to help you learn how to improve your diet and physical activity
At Months 6 and 12, you will also:
* Complete the computer-based survey about your mood, diet, and physical activity.
* Have your height, weight, waistline and blood pressure measured.
* Your non-fasting blood glucose and cholesterol levels will be measured.
* Be given an accelerometer to wear for 7 days.You will be given a prepaid envelope to return the accelerometer to the study staff.
If you are in Group 2, you will also take part in the MAPS program. For the MAPS program, you will have 12 counseling phone calls over 1 year. Each of these phone calls will be digitally recorded and should last about 20-30 minutes. You may decline to have your counseling phone call recorded if it makes you feel uncomfortable. The purpose of the phone calls are to provide support to you on changes in your diet or physical activity and to answer any questions you may have about your program.
Length of Study:
You will remain on the study for up to 1 year. Your participation on this study will be over once you complete the study visit at Month 12.
Other Important Information:
You may be contacted by phone, mail, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information for family members and/or friends for the study staff to contact in the event there is trouble reaching you first.
If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away.
All participant's paper files will be stored in locked file cabinets and all data files will be stored in a password-protected databases. The information discussed during the counseling phone calls will be kept confidential. Only members of the research team will have access to the recordings.
This is an investigational study.
Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: