Obesity: Cancer Risk Among African Americans
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01294657
First received: February 10, 2011
Last updated: September 7, 2016
Last verified: September 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer Obesity |
Behavioral: Health Education Behavioral: MAPS |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Obesity: Cancer Risk Among African Americans-Developing Interventions Through Community Collaboration |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Efficacy of a Motivation and Problem Solving (MAPS) Approach to Promoting and Facilitating Positive Health Behavior Change Among African Americans [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
16 saliva samples to be collected for hormone testing.
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HE Group
Health Education [HE] - Counseling, referrals to resources + self-help materials; 2 HE interventions at Baseline + 6 month visits.
|
Behavioral: Health Education
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.
Other Names:
|
|
MAPS Group
Motivation And Problem Solving (MAPS) - HE + 12 telephone counseling sessions over 1-year period (average 1 call/month).
|
Behavioral: Health Education
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.
Other Names:
Behavioral: MAPS
12 counseling phone calls over 1 year, lasting about 20-30 minutes.
Other Name: Counseling
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
African Americans will be recruited from Windsor Village United Methodist Church in Houston, Texas.
Criteria
Inclusion Criteria:
- Self-reported African American race
- Ability to engage in low to moderate physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if currently taking medication for blood pressure or diabetes.
- Blood pressure reading <140/90 mm Hg or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading >=140/90 mm Hg.
- Functioning telephone number
- 18-65 years of age
- Overweight or obese as defined by BMI
- Not currently exercising (<150 minutes/week) and/or not consuming 5 or more servings of fruits and vegetables per day
Exclusion Criteria:
- Pressure readings >140/90 mm Hg, as defined by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be excluded from the study.
- Currently taking medication for blood pressure or heart condition, or other physical limitations that might be aggravated by participation in moderate-intensity PA as measured using the PA Readiness Questionnaire, and any physical limitation that prevents engaging in PA.
- Pregnant or thinking about becoming pregnant during the study period
- Another household member enrolled in the study
- Member of the church advisory board
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294657
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294657
Locations
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Lorna H. McNeill, PHD,MPH | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01294657 History of Changes |
| Other Study ID Numbers: | 2010-0161 |
| Study First Received: | February 10, 2011 |
| Last Updated: | September 7, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Obesity Cancer Risk African Americans Diet Physical Activity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on September 30, 2016