NCT01778712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

October 24, 2012

Last Update Submit

April 25, 2016

Conditions

MenopauseVisceral Adipose Tissue AccumulationAbdominal ObesityObesityOverweight

Keywords

Multi-level interventionMenopauseBody compositionAbdominal adipose tissueVisceral adipose tissuePerceived stressComputed tomographyDual energy X-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Effects of the multi-level intervention

    At two years from baseline

  • Effects of the multi-level intervention

    At two years from baseline

  • Effects of the multi-level intervention

    At two years from baseline

  • Effects of the multi-level intervention

    At two years from baseline

  • Effects of the multi-level intervention

    At two years from baseline

  • +2 more secondary outcomes

Other Outcomes (1)

  • Change in body composition

    At two years from baseline

Study Arms (1)

Intervention

EXPERIMENTAL

Multi-level intervention

Behavioral: Multi-level intervention

Interventions

Multi-level interventionBEHAVIORAL

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

Also known as: Lifestyle program
Intervention

Eligibility Criteria

Age42 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Preventive Medicine, Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Obesity, AbdominalObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lynda H. Powell, PhD, MEd

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MEd

Study Record Dates

First Submitted

October 24, 2012

First Posted

January 29, 2013

Study Start

April 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

US(1)