Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Menopause, Visceral Adipose Tissue Accumulation, Abdominal Obesity, Obesity, Overweight

Intervention / Treatment
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* Behavioral: Multi-level intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Multi-level intervention | Behavioral: Multi-level intervention<br>* The development of a lifestyle program intended to intervene on the individual, social network and community over two years<br>* Other names: Lifestyle program;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-level intervention, Menopause, Body composition, Abdominal adipose tissue, Visceral adipose tissue, Perceived stress, Computed tomography, Dual energy X-ray absorptiometry