Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01778712

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopause Visceral Adipose Tissue Accumulation Abdominal Obesity Obesity Overweight	Behavioral: Multi-level intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in visceral adipose tissue, as measured by CT [At two years from baseline]
<4% gain in visceral adipose tissue over a 2-year period

Secondary Outcome Measures

Effects of the multi-level intervention [At two years from baseline]
Physical activity as assessed by accelerometer (min/week of >= 3 MET)
Effects of the multi-level intervention [At two years from baseline]
Proportion or participants meeting a 120 min/week physical activity goal
Effects of the multi-level intervention [At two years from baseline]
Vitality subscale of the SF36 questionnaire
Effects of the multi-level intervention [At two years from baseline]
Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)
Effects of the multi-level intervention [At two years from baseline]
Assess Perceived stress
Effects of the multi-level intervention [At two years from baseline]
Assess Perceived social support
Effects of the multi-level intervention [At two years from baseline]
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 [At 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

42 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.