Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Not Applicable

Completed

• Conditions: Menopause; Abdominal Obesity; Obesity; Overweight; Visceral Adipose Tissue Accumulation
• Interventions: Behavioral: Multi-level intervention

• Registration Number: NCT01778712
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Multi-level intervention	Multi-level intervention

Primary Outcome Measures

Name	Time	Method
Change in visceral adipose tissue, as measured by CT	At two years from baseline	\<4% gain in visceral adipose tissue over a 2-year period

Secondary Outcome Measures

Name	Time	Method
Effects of the multi-level intervention	At two years from baseline	Knowledge of menopausal effects on health in the target community, as assessed by the "man on the street" survey

Trial Locations

Locations (1)

Department of Preventive Medicine, Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States