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Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

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Status

Completed

Conditions

Overweight
Abdominal Obesity
Menopause
Obesity
Visceral Adipose Tissue Accumulation

Treatments

Behavioral: Multi-level intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01778712
5U01HL097894-03 (U.S. NIH Grant/Contract)
09090108

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

Female

Ages

42+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

71 participants in 1 patient group

Intervention
Experimental group
Description:
Multi-level intervention
Treatment:
Behavioral: Multi-level intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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