NCT01139242

Brief Summary

This is an intervention study to increase colorectal cancer screening and physical activity in members of African-American churches who are 50 years old and older. The control arm receives the Body \& Soul program, a program to increase fruit and vegetable intake. The investigators hypothesize that those receiving the intervention, which includes four tailored newsletters and peer counseling, will be more likely to be screened if not up-to-date, and more likely to increase physical activity if screening was up-to-date at baseline, than controls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
955

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2008

Status
completed

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

February 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
Last Updated

February 26, 2024

Status Verified

June 1, 2010

Enrollment Period

1.5 years

First QC Date

June 4, 2010

Last Update Submit

February 22, 2024

Conditions

Keywords

CRC screening statusphysical activity levelfruit and vegetable consumptionEarly Detection of CancerColorectal Cancer (CRC) screening status

Outcome Measures

Primary Outcomes (1)

  • Higher incidence of CRC screening, if needed, among experimental participants.

    Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.

    One year

Study Arms (2)

Body & Soul nutritional intervention

OTHER

This is a standardized intervention to increase fruit and vegetable consumption among church members through pastoral and peer counseling and church activities/menus.

Behavioral: Body & Soul nutritional intervention

Newsletters/peer counseling

EXPERIMENTAL

Four tailored newsletters and peer counseling calls to promote CRC screening among church members out-of-date according to screening guidelines. For those up-to-date, promotion is of increased physical activity.

Behavioral: Experimental: newsletters and peer counseling

Interventions

Pastoral and peer counseling, and church activities/menus to promote increased fruit and vegetable consumption among church members.

Body & Soul nutritional intervention

Four tailored newsletters and peer counseling calls to promote CRC screening in church members who are out-of-date with screening. Four tailored newsletters and peer counseling calls to others to increase physical activity.

Newsletters/peer counseling

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Members of African-American churches who are at least 50 years old.

You may not qualify if:

  • Non-members of African-American churches; members who are under 50 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Marci K Campbell, PhD

    UNC - Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 8, 2010

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

May 1, 2010

Last Updated

February 26, 2024

Record last verified: 2010-06