Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation
This study is currently recruiting participants.
Verified January 2013 by Rush University Medical Center
Sponsor:
Rush University Medical Center
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 25, 2013
Last verified: January 2013
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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)
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | July 2014 (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 to 52 Years |
| 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 to 52
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778712
Contacts
| Contact: Chiquia Hollings | 3125632120 | Chiquia_S_Hollings@rush.edu |
Locations
| United States, Illinois | |
| Department of Preventive Medicine, Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Chiquia Hollings 312-563-2123 wish_fit@rush.edu | |
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 25, 2013 |
| 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 Obesity, Abdominal Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013