NCT00288327

Brief Summary

The overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically for this demographic group as part of the CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled trial in a community health center setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

1.8 years

First QC Date

February 6, 2006

Last Update Submit

March 12, 2009

Conditions

Cardiovascular Disease

Keywords

dietphysical activitysmoking cessation

Outcome Measures

Primary Outcomes (4)

  • physical activity

  • fruit intake

  • vegetable intake

  • fat intake

Secondary Outcomes (3)

  • Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);

  • CVD risk factors (total and HDL cholesterol, blood pressure);

  • Psychosocial variables

Study Arms (2)

1

EXPERIMENTAL

Enhanced New Leaf Intervention

Behavioral: Lifestyle behavior change program

2

OTHER

Minimum Intervention

Behavioral: Pamphlets

Interventions

Lifestyle behavior change programBEHAVIORAL

Intervention included a six-month intensive intervention of 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls.

1
PamphletsBEHAVIORAL

Nutritional and physical activity pamphlets from American Heart Association

2

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women 40-64 years old
  • Patient at participating site who is considered an appropriate candidate by the primary care clinician
  • Ability and willingness to provide informed consent
  • Availability for follow-up--plan to reside within 50 miles of study site for 1 year
  • Home phone or easy access to phone

You may not qualify if:

  • Medical condition for which intervention may not be appropriate
  • Pregnancy/lactation
  • Severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Hanover Community Health Center

Wilmington, North Carolina, 28401, United States

Location

Related Publications (2)

  • Rosamond WD, Ammerman AS, Holliday JL, Tawney KW, Hunt KJ, Keyserling TC, Will JC, Mokdad AH. Cardiovascular disease risk factor intervention in low-income women: the North Carolina WISEWOMAN project. Prev Med. 2000 Oct;31(4):370-9. doi: 10.1006/pmed.2000.0726.

    PMID: 11006062BACKGROUND

  • Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med. 2008 Jun;46(6):499-510. doi: 10.1016/j.ypmed.2008.02.011. Epub 2008 Feb 15.

    PMID: 18394692DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMotor ActivitySmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Alice S Ammerman, DrPH, RD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

March 1, 2003

Primary Completion

December 1, 2004

Study Completion

January 1, 2005

Last Updated

March 13, 2009

Record last verified: 2009-03

Locations

US(1)