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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.
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):
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:
At Months 6 and 12, you will also:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HE Group | Health Education [HE] - Counseling, referrals to resources + self-help materials; 2 HE interventions at Baseline + 6 month visits. |
| |
| MAPS Group | Motivation And Problem Solving (MAPS) - HE + 12 telephone counseling sessions over 1-year period (average 1 call/month). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | Counseling, referrals to available resources and self-help materials on Day 1, at 6 and 12 month visits, along with surveys at 6 and 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of a Motivation and Problem Solving (MAPS) Approach to Promoting and Facilitating Positive Health Behavior Change Among African Americans | Effects of MAPS on each of modifiable risk factors, assessed at 6 and 12-month follow-up visits using, using Questionnaire Design System (QDS), a computer-administered self-interview format. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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African Americans will be recruited from Windsor Village United Methodist Church in Houston, Texas.
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| Name | Affiliation | Role |
|---|---|---|
| Lorna H. McNeill, PHD,MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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16 saliva samples to be collected for hormone testing.
|
| MAPS | Behavioral | 12 counseling phone calls over 1 year, lasting about 20-30 minutes. |
|
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |