Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

NCT ID: NCT01778712

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause Visceral Adipose Tissue Accumulation Abdominal Obesity Obesity Overweight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Multi-level intervention

Group Type EXPERIMENTAL

Multi-level intervention

Intervention Type BEHAVIORAL

The development of a lifestyle program intended to intervene on the individual, social network and community over two years

Interventions

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Multi-level intervention

The development of a lifestyle program intended to intervene on the individual, social network and community over two years

Intervention Type BEHAVIORAL

Other Intervention Names

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Lifestyle program

Eligibility Criteria

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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.
Minimum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lynda Powell, PhD, MEd

PhD, MEd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynda H. Powell, PhD, MEd

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Department of Preventive Medicine, Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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5U01HL097894-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09090108

Identifier Type: -

Identifier Source: org_study_id

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