Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Menopause; Abdominal Obesity; Visceral Adipose Tissue Accumulation
• Intervention / Treatment: Behavioral: Multi-level intervention

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Department of Preventive Medicine, Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Lifestyle program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visceral adipose tissue, as measured by CT	<4% gain in visceral adipose tissue over a 2-year period	At two years from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of the multi-level intervention	Physical activity as assessed by accelerometer (min/week of >= 3 MET)	At two years from baseline
Effects of the multi-level intervention	Proportion or participants meeting a 120 min/week physical activity goal	At two years from baseline
Effects of the multi-level intervention	Vitality subscale of the SF36 questionnaire	At two years from baseline
Effects of the multi-level intervention	Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)	At two years from baseline
Effects of the multi-level intervention	Assess Perceived stress	At two years from baseline
Effects of the multi-level intervention	Assess Perceived social support	At two years from baseline
Effects of the multi-level intervention	Knowledge of menopausal effects on health in the target community, as assessed by the "man on the street" survey	At two years from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition	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)	At two years from baseline

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Lynda H. Powell, PhD, MEd, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimate): January 29, 2013

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Computed tomography; Menopause; Body composition; Perceived stress; Visceral adipose tissue; Multi-level intervention; Abdominal adipose tissue; Dual energy X-ray absorptiometry
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Obesity, Abdominal
• Other Study ID Numbers: 09090108; 5U01HL097894-03 (U.S. NIH Grant/Contract)