Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lynda Powell, PhD, MEd, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01778712
First received: October 24, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Menopause
Visceral Adipose Tissue Accumulation
Abdominal Obesity
Obesity
Overweight
Behavioral: Multi-level intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation in Premenopausal Women: WISHfit Phase 2

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Change in visceral adipose tissue, as measured by CT [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    <4% gain in visceral adipose tissue over a 2-year period


Secondary Outcome Measures:
  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Physical activity as assessed by accelerometer (min/week of >= 3 MET)

  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Proportion or participants meeting a 120 min/week physical activity goal

  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Vitality subscale of the SF36 questionnaire

  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)

  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Assess Perceived stress

  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Assess Perceived social support

  • Effects of the multi-level intervention [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    Knowledge of menopausal effects on health in the target community, as assessed by the "man on the street" survey


Other Outcome Measures:
  • Change in body composition [ Time Frame: At two years from baseline ] [ Designated as safety issue: No ]
    • 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)


Enrollment: 71
Study Start Date: April 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Multi-level intervention
Behavioral: Multi-level intervention
The development of a lifestyle program intended to intervene on the individual, social network and community over two years
Other Name: Lifestyle program

  Eligibility

Ages Eligible for Study:   42 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778712

Locations
United States, Illinois
Department of Preventive Medicine, Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Lynda H. Powell, PhD, MEd Rush University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Lynda Powell, PhD, MEd, PhD, MEd, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01778712     History of Changes
Other Study ID Numbers: 09090108, 5U01HL097894-03
Study First Received: October 24, 2012
Last Updated: January 31, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Rush University Medical Center:
Multi-level intervention
Menopause
Body composition
Abdominal adipose tissue
Visceral adipose tissue
Perceived stress
Computed tomography
Dual energy X-ray absorptiometry

Additional relevant MeSH terms:
Obesity
Overweight
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014