Obesity: Cancer Risk Among African Americans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01294657
First received: February 10, 2011
Last updated: August 22, 2013
Last verified: August 2013
  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 2015 (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:
  • 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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:

  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
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

Locations
United States, Texas
UT 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 UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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: August 22, 2013
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 July 29, 2014