NCT00153400

Brief Summary

The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2006

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

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

September 8, 2005

Last Update Submit

August 2, 2024

Conditions

Cardiovascular DiseasesChronic Diseases

Keywords

CVD risk

Outcome Measures

Primary Outcomes (1)

  • CVD risk (10 year estimated risk)

    Combines a number of risk factors into one metric. Lower score means lower risk. Higher score means higher risk. Low risk (0 to \<5, borderline risk (5 to \<7.5), intermediate risk (7.5 to \< 20), and high risk (\>20). Range 0 to 20.

    baseline, one-year

Secondary Outcomes (2)

  • Physical Activity

    baseline, one-year

  • Dietary Behavior

    baseline, one-year

Study Arms (1)

Enhanced Lifestyle Intervention

EXPERIMENTAL

Three health coaching sessions or Lifestyle Programs on physical activity and nutrition are delivered to each woman. Support is offered by community health workers.

Behavioral: Enhanced Lifestyle Intervention

Interventions

Enhanced Lifestyle InterventionBEHAVIORAL

Three face-to-face counseling sessions for nutrition and physical activity. Used a Spanish culturally tailored materials. These interventions were delivered by community health workers (CHWs) who are trained.

Also known as: YWCA Health Coaching and Walk with Ease
Enhanced Lifestyle Intervention

Eligibility Criteria

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

You may qualify if:

  • National Breast and Cervical Cancer Early Detection Program (NBCCEDP)participants without cancer
  • Income \< 200 percent of federal poverty level
  • Under or uninsured for the health care coverage
  • Blood pressure \>= 120 mm Hg systolic or \>=80 mm Hg diastolic or currently taking medication to lower cholesterol

You may not qualify if:

  • \>180 mm Hg systolic or \>110 mm Hg diastolic
  • \> 400 cholesterol
  • pregnant women
  • had past or current CVD events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Silverstein RP, VanderVos M, Welch H, Long A, Kabore CD, Hootman JM. Self-Directed Walk With Ease Workplace Wellness Program - Montana, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 23;67(46):1295-1299. doi: 10.15585/mmwr.mm6746a3.

    PMID: 30462629BACKGROUND

  • Ahmann E, Saviet M, Conboy L, Smith K, Iachini B, DeMartin R. Health and Wellness Coaching and Sustained Gains: A Rapid Systematic Review. Am J Lifestyle Med. 2023 Jun 20;18(2):162-180. doi: 10.1177/15598276231180117. eCollection 2024 Mar-Apr.

    PMID: 38559782RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesChronic Disease

Interventions

Walkingmethyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Julie Will

    Centers for Disease Control and Prevention

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Low income uninsured and underinsured participants.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Provide Health coaching and Lifestyle programs
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 5, 2024

Record last verified: 2024-08