NCT00023543

Brief Summary

The purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy (HRT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P75+ for phase_2 cardiovascular-diseases

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_2 cardiovascular-diseases

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

September 1, 2001

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

September 7, 2001

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

8.7 years

First QC Date

September 7, 2001

Last Update Submit

June 18, 2013

Conditions

Cardiovascular DiseasesAtherosclerosisPostmenopauseHeart Diseases

Outcome Measures

Primary Outcomes (4)

  • Measures of subclinical disease

    5 years

  • Change in coronary calcium (EBCT)

    5 years

  • Change in carotid intima media wall thickness

    5 years

  • Change in vascular stiffness (PWV)

    5 years

Secondary Outcomes (5)

  • Change in waist circumference and weight

    5 years

  • Change in LDL particles, triglycerides and small, medium and large LDL particles

    5 years

  • Change in HDL particles

    5 years

  • Change in insulin and glucose

    5 years

  • Change in systolic blood pressure, diastolic blood pressure

    5 years

Study Arms (1)

1

EXPERIMENTAL

Participants will reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight.

Behavioral: Diet, fat-restrictedBehavioral: Exercise

Interventions

Diet, fat-restrictedBEHAVIORAL

Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.

1
ExerciseBEHAVIORAL

Rigorous, stepped care approach to reach 150 min/week of physical activity.

1

Eligibility Criteria

Age52 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • On HRT for at least two years
  • Women 52 to 60 years of age
  • Three or more years postmenopausal
  • Waist circumference greater than 80 cm
  • LDLc between 100 and 160 mg/dl
  • Body mass index 25-39.9 kg/m2
  • Blood Pressure less than 160/95 mm Hg
  • Beck Depression Inventory Score less than 20

You may not qualify if:

  • Current use of cholesterol-lowering medication
  • Diagnosis of diabetes
  • On diabetes medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

  • Kuller LH, Kinzel LS, Pettee KK, Kriska AM, Simkin-Silverman LR, Conroy MB, Averbach F, Pappert WS, Johnson BD. Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial. J Womens Health (Larchmt). 2006 Oct;15(8):962-74. doi: 10.1089/jwh.2006.15.962.

    PMID: 17087620RESULT

  • Kuller LH, Pettee Gabriel KK, Kinzel LS, Underwood DA, Conroy MB, Chang Y, Mackey RH, Edmundowicz D, Tyrrell KS, Buhari AM, Kriska AM. The Women on the Move Through Activity and Nutrition (WOMAN) study: final 48-month results. Obesity (Silver Spring). 2012 Mar;20(3):636-43. doi: 10.1038/oby.2011.80. Epub 2011 Apr 14.

    PMID: 21494228DERIVED

  • Gabriel KP, McClain JJ, Schmid KK, Storti KL, High RR, Underwood DA, Kuller LH, Kriska AM. Issues in accelerometer methodology: the role of epoch length on estimates of physical activity and relationships with health outcomes in overweight, post-menopausal women. Int J Behav Nutr Phys Act. 2010 Jun 15;7:53. doi: 10.1186/1479-5868-7-53.

    PMID: 20550691DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosisHeart Diseases

Interventions

Diet, Fat-RestrictedExercise

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lewis H. Kuller, MD, DPH

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2001

First Posted

September 7, 2001

Study Start

September 1, 2001

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)