Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778712
• Other study ID #: 09090108
• Secondary ID: 5U01HL097894-03
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: April 25, 2016
• Start date: April 2012
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Multi-level intervention
The development of a lifestyle program intended to intervene on the individual, social network and community over two years

Locations

Country	Name	City	State
United States	Department of Preventive Medicine, Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	Effects of the multi-level intervention	Physical activity as assessed by accelerometer (min/week of >= 3 MET)	At two years from baseline	No
Secondary	Effects of the multi-level intervention	Proportion or participants meeting a 120 min/week physical activity goal	At two years from baseline	No
Secondary	Effects of the multi-level intervention	Vitality subscale of the SF36 questionnaire	At two years from baseline	No
Secondary	Effects of the multi-level intervention	Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)	At two years from baseline	No
Secondary	Effects of the multi-level intervention	Assess Perceived stress	At two years from baseline	No
Secondary	Effects of the multi-level intervention	Assess Perceived social support	At two years from baseline	No
Secondary	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	No

External Links

•   WISHFIT Study Website