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Completed

NCT Number: NCT01778712

Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

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.

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Key information

Conditions

Menopause Abdominal Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Visceral Adipose Tissue Accumulation

Age range

42 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Preventive Medicine, Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-Level Intervention

Behavioral

The development of a lifestyle program intended to intervene on the individual, social network and community over two years

Other names: Lifestyle program

Primary outcomes

  1. Change in visceral adipose tissue, as measured by CT

    Time frame: At two years from baseline

    <4% gain in visceral adipose tissue over a 2-year period

Secondary outcomes

  1. Effects of the multi-level intervention

    Time frame: At two years from baseline

    Physical activity as assessed by accelerometer (min/week of >= 3 MET)

  2. Effects of the multi-level intervention

    Time frame: At two years from baseline

    Proportion or participants meeting a 120 min/week physical activity goal

  3. Effects of the multi-level intervention

    Time frame: At two years from baseline

    Vitality subscale of the SF36 questionnaire

  4. Effects of the multi-level intervention

    Time frame: At two years from baseline

    Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)

  5. Effects of the multi-level intervention

    Time frame: At two years from baseline

    Assess Perceived stress

  6. Effects of the multi-level intervention

    Time frame: At two years from baseline

    Assess Perceived social support

  7. Effects of the multi-level intervention

    Time frame: 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 outcomes

  1. Change in body composition

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2013
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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