NCT01294657

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

9 years

First QC Date

February 10, 2011

Last Update Submit

May 9, 2019

Conditions

Keywords

ObesityCancer RiskAfrican AmericansDietPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

HE Group

Health Education \[HE\] - Counseling, referrals to resources + self-help materials; 2 HE interventions at Baseline + 6 month visits.

Behavioral: Health Education

MAPS Group

Motivation And Problem Solving (MAPS) - HE + 12 telephone counseling sessions over 1-year period (average 1 call/month).

Behavioral: Health EducationBehavioral: MAPS

Interventions

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.

Also known as: Survey, Counseling
HE GroupMAPS Group
MAPSBEHAVIORAL

12 counseling phone calls over 1 year, lasting about 20-30 minutes.

Also known as: Counseling
MAPS Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

African Americans will be recruited from Windsor Village United Methodist Church in Houston, Texas.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

16 saliva samples to be collected for hormone testing.

MeSH Terms

Conditions

NeoplasmsObesityMotor Activity

Interventions

Surveys and QuestionnairesCounseling

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lorna H. McNeill, PHD,MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations