search
Back to results

Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Primary Purpose

Menopause, Visceral Adipose Tissue Accumulation, Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-level intervention
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Menopause focused on measuring Multi-level intervention, Menopause, Body composition, Abdominal adipose tissue, Visceral adipose tissue, Perceived stress, Computed tomography, Dual energy X-ray absorptiometry

Eligibility Criteria

42 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Resident of the Beverly or Morgan Park neighborhood of Chicago or contiguous neighborhoods
  • Female
  • African American or Caucasian
  • Age 42 years or older
  • Intact uterus, at least one functioning ovary, at least one menstrual period in the last 12 months prior to screening.
  • Sufficient motivation level to make lifestyle changes, as determined by WISHFIT staff.

Exclusion Criteria:

  • Hysterectomy
  • Physical activity > 90 min per week
  • Metabolic conditions or use of medications that affect weight of visceral adipose tissue (diabetes, acquired immune deficiency syndrome, weight > 300 lbs)
  • Presence or history of major psychiatric comorbidity (i.e. dementia, schizophrenia, bipolar disorder, alcohol/drug addiction) in the last 6 months
  • History of inpatient mental health treatment
  • Currently prescribed antipsychotic medication
  • History of hallucinations or bizarre thoughts
  • Current pregnancy
  • Has been told by a physician that it is unsafe to engage in physical activity
  • An illness expected to limit functional status or life expectancy, including: heart failure, recent heart attack, liver cirrhosis, kidney failure, oncologic conditions, history or heart surgery, angioplasty or artery stenting.

Sites / Locations

  • Department of Preventive Medicine, Rush University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Multi-level intervention

Outcomes

Primary Outcome Measures

Change in visceral adipose tissue, as measured by CT
<4% gain in visceral adipose tissue over a 2-year period

Secondary Outcome Measures

Effects of the multi-level intervention
Physical activity as assessed by accelerometer (min/week of >= 3 MET)
Effects of the multi-level intervention
Proportion or participants meeting a 120 min/week physical activity goal
Effects of the multi-level intervention
Vitality subscale of the SF36 questionnaire
Effects of the multi-level intervention
Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)
Effects of the multi-level intervention
Assess Perceived stress
Effects of the multi-level intervention
Assess Perceived social support
Effects of the multi-level intervention
Knowledge of menopausal effects on health in the target community, as assessed by the "man on the street" survey

Full Information

First Posted
October 24, 2012
Last Updated
April 25, 2016
Sponsor
Rush University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01778712
Brief Title
Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation
Official Title
Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation in Premenopausal Women: WISHfit Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to develop an intervention that will produce a sustained improvement in physical activity and chronic stress as a means to slow the menopause-related accumulation of visceral adipose tissue in mid-life women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Visceral Adipose Tissue Accumulation, Abdominal Obesity, Obesity, Overweight
Keywords
Multi-level intervention, Menopause, Body composition, Abdominal adipose tissue, Visceral adipose tissue, Perceived stress, Computed tomography, Dual energy X-ray absorptiometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Multi-level intervention
Intervention Type
Behavioral
Intervention Name(s)
Multi-level intervention
Other Intervention Name(s)
Lifestyle program
Intervention Description
The development of a lifestyle program intended to intervene on the individual, social network and community over two years
Primary Outcome Measure Information:
Title
Change in visceral adipose tissue, as measured by CT
Description
<4% gain in visceral adipose tissue over a 2-year period
Time Frame
At two years from baseline
Secondary Outcome Measure Information:
Title
Effects of the multi-level intervention
Description
Physical activity as assessed by accelerometer (min/week of >= 3 MET)
Time Frame
At two years from baseline
Title
Effects of the multi-level intervention
Description
Proportion or participants meeting a 120 min/week physical activity goal
Time Frame
At two years from baseline
Title
Effects of the multi-level intervention
Description
Vitality subscale of the SF36 questionnaire
Time Frame
At two years from baseline
Title
Effects of the multi-level intervention
Description
Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)
Time Frame
At two years from baseline
Title
Effects of the multi-level intervention
Description
Assess Perceived stress
Time Frame
At two years from baseline
Title
Effects of the multi-level intervention
Description
Assess Perceived social support
Time Frame
At two years from baseline
Title
Effects of the multi-level intervention
Description
Knowledge of menopausal effects on health in the target community, as assessed by the "man on the street" survey
Time Frame
At two years from baseline
Other Pre-specified Outcome Measures:
Title
Change in body composition
Description
Change in waist girth and BMI Subcutaneous and visceral adipose tissue as measured by CT Body composition as measured by dual energy X-ray absorptiometry (fat, lean mass)
Time Frame
At two years from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Resident of the Beverly or Morgan Park neighborhood of Chicago or contiguous neighborhoods Female African American or Caucasian Age 42 years or older Intact uterus, at least one functioning ovary, at least one menstrual period in the last 12 months prior to screening. Sufficient motivation level to make lifestyle changes, as determined by WISHFIT staff. Exclusion Criteria: Hysterectomy Physical activity > 90 min per week Metabolic conditions or use of medications that affect weight of visceral adipose tissue (diabetes, acquired immune deficiency syndrome, weight > 300 lbs) Presence or history of major psychiatric comorbidity (i.e. dementia, schizophrenia, bipolar disorder, alcohol/drug addiction) in the last 6 months History of inpatient mental health treatment Currently prescribed antipsychotic medication History of hallucinations or bizarre thoughts Current pregnancy Has been told by a physician that it is unsafe to engage in physical activity An illness expected to limit functional status or life expectancy, including: heart failure, recent heart attack, liver cirrhosis, kidney failure, oncologic conditions, history or heart surgery, angioplasty or artery stenting.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda H. Powell, PhD, MEd
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Preventive Medicine, Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

We'll reach out to this number within 24 hrs