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Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation in Premenopausal Women: WISHfit Phase 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01778712
Enrollment
71
Registered
2013-01-29
Start date
2012-04-30
Completion date
2016-02-29
Last updated
2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Obesity, Menopause, Obesity, Overweight, Visceral Adipose Tissue Accumulation

Keywords

Multi-level intervention, Menopause, Body composition, Abdominal adipose tissue, Visceral adipose tissue, Perceived stress, Computed tomography, Dual energy X-ray absorptiometry

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.

Interventions

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
42 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in visceral adipose tissue, as measured by CTAt two years from baseline\<4% gain in visceral adipose tissue over a 2-year period

Secondary

MeasureTime frameDescription
Effects of the multi-level interventionAt two years from baselinePhysical activity as assessed by accelerometer (min/week of \>= 3 MET)

Other

MeasureTime frameDescription
Change in body compositionAt two years from baseline* 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026