Study Stopped
no further funding
Genetic Evaluation and Modification of Lifestyles to Improve Female Life Expectancy
GEMLIFE
1 other identifier
interventional
5
1 country
1
Brief Summary
The GEMLIFE Study is a 12-month clinical trial for menopausal women. The purpose of this study is to promote an improved aging process for women in menopause through lifestyle changes. The changes will include a heart healthy diet, structured walking program, and mindfulness-based stress reduction. During the study, the investigators will monitor components of your genetic make-up that will tell us how you are aging. Investigators will also monitor bloodwork for inflammation that can affect medical conditions. Study participants may qualify if you are within 5 years of your last menstrual period and have well controlled medical conditions. There is no cost to participants to enroll in the study- only potential benefits to the participant's health and aging process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
1 active site
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
First Submitted
Initial submission to the registry
June 21, 2021
CompletedStudy Start
First participant enrolled
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedFebruary 13, 2023
February 1, 2023
Same day
June 21, 2021
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Independent Lifestyle Interventions on Telomere Length
Measurement of telomere length after 12 months of a Mediterranean diet, American Heart Association walking program, and mindfulness-based stress reduction program.
12 months
Secondary Outcomes (2)
Lifestyle Interventions on Inflammatory Biomarkers and Cytokines
12 months
Measurement of Interventions on Inflammatory Biomarkers and Cytokines
12 months
Other Outcomes (1)
Measurement of Menopausal aging due to stress and inflammation of the microbiome
12 months
Study Arms (4)
Intervention group of menopausal women on hormone replacement
ACTIVE COMPARATORThis group of women on hormone replacement will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs.
Control group of menopausal women on hormone replacement
PLACEBO COMPARATORThis group of women on hormone replacement will be given unstructured guidelines for diet, physical activity, and stress-reduction.
Intervention group of menopausal women without hormone replacement
ACTIVE COMPARATORThis group of women will have specific, structured diet, physical activity, and mindfulness-based stress reduction programs.
Control group of menopausal women without hormone replacement
PLACEBO COMPARATORThis group of women will be given unstructured guidelines for diet, physical activity, and stress-reduction.
Interventions
12-week structured program for Mediterranean diet.
12-week structured AHA walking program.
8-week structured mindfulness-based stress reduction (Cabot).
Unstructured 12-week program with basic outline for Mediterranean diet.
Unstructured 12-week walking program.
Unstructured program using mobile application for stress reduction.
Eligibility Criteria
You may qualify if:
- Non-hysterectomized women: Amenorrhea \> 12 consecutive months
- Hysterectomized women: Bilateral oophorectomy (3 months after surgery)
- Normal mammogram in the past year
- Normal pap smear deemed to be negative within 5 years
- Able to understand the protocol and sign an informed consent
- Able to participate in a structured diet program for 12 weeks
- Able to participate in a structured walking program for 12 weeks
- Able to participate in a structured mindfulness-stress reduction program
- Able to operate an I-PAD, and able to connect to the internet
You may not qualify if:
- Known or suspected pregnancy
- Undiagnosed abnormal vaginal bleeding
- Known or suspected breast cancer or estrogen-dependent neoplasia
- Known or at risk for a MI, PE or significant cardiovascular event
- Poorly controlled blood pressure : sitting systolic \> 160 or diastolic \>95 mmHg
- Poorly controlled diabetes
- Uncontrolled thyroid disease
- Impaired liver function
- Unstable psychiatric disorder including depression or anxiety, PTSD
- History of drug or alcohol abuse
- Treatment with anticoagulants ( heparin, warfarin, lovenox, eliquis)
- Severe systemic disease which might interfere with interpretation of results
- Unwilling or unable to follow a diet, exercise or stress reduction protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Soltes, MD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Computer-assigned.
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
June 21, 2021
First Posted
February 8, 2023
Study Start
June 22, 2021
Primary Completion
June 22, 2021
Study Completion
June 22, 2021
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share