MenopauseNCT01778712
Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation
A study testing Multi-level intervention in people with Menopause and Visceral Adipose Tissue Accumulation, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 42 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Visceral Adipose Tissue Accumulation, Abdominal Obesity
- What is being tested?
- Multi-level intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Preventive Medicine, Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation in Premenopausal Women: WISHfit Phase 2
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.
- Being tested
- Multi-level intervention
- Keywords
- Multi-level intervention, Menopause, Body composition, Abdominal adipose tissue, Visceral adipose tissue, Perceived stress, Computed tomography, Dual energy X-ray absorptiometry
- Medical subject headings
- Obesity, Abdominal, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level interventionBehavioural
Also called Lifestyle program
The development of a lifestyle program intended to intervene on the individual, social network and community over two years
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Multi-level intervention Receives: Behavioral: Multi-level intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visceral adipose tissue, as measured by CT
<4% gain in visceral adipose tissue over a 2-year period
Measured: At two years from baseline
Secondary outcomes (7)
Effects of the multi-level intervention
Physical activity as assessed by accelerometer (min/week of >= 3 MET)
Measured: At two years from baseline
Effects of the multi-level intervention
Proportion or participants meeting a 120 min/week physical activity goal
Measured: At two years from baseline
Effects of the multi-level intervention
Vitality subscale of the SF36 questionnaire
Measured: At two years from baseline
Effects of the multi-level intervention
Assess Dietary changes (vegetable, protein, fat, sugar-sweetened beverage consumption)
Measured: At two years from baseline
Effects of the multi-level intervention
Assess Perceived stress
Measured: At two years from baseline
Effects of the multi-level intervention
Assess Perceived social support
Measured: 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
Measured: At two years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Lynda Powell, PhD, MEd, Rush University Medical Center
- Investigators
- Lynda H. Powell, PhD, MEd, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778712
- Sponsor's protocol ID
- 09090108
- Other IDs
- 5U01HL097894-03
- Status last verified
- Apr 2016
- First submitted
- 24 Oct 2012
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation in Premenopausal Women: WISHfit Phase 2
- ClinicalTrials.gov ID
- NCT01778712
- Acronym / sponsor ID
- 09090108
- Keywords
- Multi-level intervention, Menopause, Body composition, Abdominal adipose tissue, Visceral adipose tissue, Perceived stress, Computed tomography, Dual energy X-ray absorptiometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multi-level interventionMulti-level intervention |
Who may qualify
- Ages
- 42 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-level interventionAlso: Lifestyle programThe development of a lifestyle program intended to intervene on the individual, social network and community over two years | Behavioural | Intervention |
Primary outcome
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
7 secondary outcomes
Effects of the multi-level intervention
Time frame: At two years from baseline
Effects of the multi-level intervention
Time frame: At two years from baseline
Effects of the multi-level intervention
Time frame: At two years from baseline
Effects of the multi-level intervention
Time frame: At two years from baseline
Effects of the multi-level intervention
Time frame: At two years from baseline
Effects of the multi-level intervention
Time frame: At two years from baseline
Effects of the multi-level intervention
Time frame: At two years from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
Related trials for Menopause
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynda H. Powell, PhD, MEd principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level intervention in people with Menopause and Visceral Adipose Tissue Accumulation, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visceral adipose tissue, as measured by CT (time frame: At two years from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.