Obesity: Cancer Risk Among African Americans

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Cancer; Obesity	Behavioral: Health Education; Behavioral: MAPS

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Study Design

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Study Type :	Observational
Estimated Enrollment :	300 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Obesity: Cancer Risk Among African Americans-Developing Interventions Through Community Collaboration
Actual Study Start Date :	January 2011
Estimated Primary Completion Date :	January 2020
Estimated Study Completion Date :	January 2021

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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: Survey; Counseling
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: Survey; Counseling Behavioral: MAPS; 12 counseling phone calls over 1 year, lasting about 20-30 minutes.; Other Name: Counseling

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Efficacy of a Motivation and Problem Solving (MAPS) Approach to Promoting and Facilitating Positive Health Behavior Change Among African Americans [ Time Frame: 6 months ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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:

1. Self-reported African American race
2. 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.
3. 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.
4. Functioning telephone number
5. 18-65 years of age
6. Overweight or obese as defined by BMI
7. Not currently exercising (<150 minutes/week) and/or not consuming 5 or more servings of fruits and vegetables per day

Exclusion Criteria:

1. 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.
2. 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.
3. Pregnant or thinking about becoming pregnant during the study period
4. Another household member enrolled in the study
5. Member of the church advisory board

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01294657 History of Changes
Other Study ID Numbers:	2010-0161
First Posted:	February 11, 2011
Last Update Posted:	February 19, 2018
Last Verified:	February 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

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