Clinical trial NCT01778712: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-01-29
Enrollment: 71
Sex: FEMALE
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in visceral adipose tissue, as measured by CT
timeFrame: At two years from baseline
Secondary outcomes:
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
measure: Effects of the multi-level intervention
timeFrame: At two years from baseline
Other outcomes:
measure: Change in body composition
timeFrame: At two years from baseline
Locations:
city: Chicago
country: United States
facility: Department of Preventive Medicine, Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Lynda H. Powell, PhD, MEd
role: PRINCIPAL_INVESTIGATOR
References: