Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00714506
Eligibility Criteria:
Inclusion Criteria:
* Age 65 and older
* BMI 28 to 39.9
* Sedentary lifestyle defined by formal exercise less than 3 times per week for a total of less than 90 minutes.
* Self report of ability to walk ΒΌ mile (2-3 blocks)
* Ability to complete the 400 meter walk without a cane or walker in less than 15 minutes
* Successful completion of the behavioral run-in phase which includes an activity log and a food diary
* Willingness to be randomized to either intervention group
* Willingness to attend meetings and physical activity sessions in McKeesport
Exclusion Criteria:
* Diabetes requiring insulin, history of diabetic coma, or diabetes out of control defined as fasting blood sugar greater than 300
* Severe hypertension, e.g. SBP\> 180, DBP \> 100
* Failure to provide informed consent
* Nursing home resident or resident in a facility where they have no control over food choices
* Significant cognitive impairment, defined as a known diagnosis of dementia or a 3MSE Cognitive Function score \< 80
* Major psychiatric disorder
* Unable to communicate because of severe hearing loss or speech disorder
* Severe visual impairment
* Celiac sprue or other malabsorption syndromes
* Consume more than 5 alcoholic drinks per day, or more than 15 drinks per week
* Progressive, degenerative neurological disease
* Severe rheumatologic or orthopedic diseases
* Stroke, hip, or knee replacement, or spinal surgery within the past 4 months or planned in the next 4 months
* Receiving physical therapy for gait, balance, or lower extremity training
* Terminal illness with life expectancy of less than 12 months
* Currently being treated with chemotherapy or radiation for breast, cervical, colon, prostate, rectal, uterine, thyroid, or oral cancer. Participant with other types of cancers, with the exception of basal and squamous cancer are ineligible
* Severe pulmonary disease (i.e., lung disease requiring supplemental oxygen or oral steroid medication) or pulmonary embolism or deep vein thrombosis within the past 6 months
* Severe cardiac disease (i.e., congestive heart failure (NYHA Class III or IV); untreated aortic stenosis; a history of cardiac arrest, the use of a cardiac defibrillator or uncontrolled angina)
* Myocardial infarction, CABG, or valve replacement in the past 6 months
* Serious conduction disorder (3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST- segment depressions (\> 3mm) on ECG
* Other significant co-morbid disease that the study medical officer deems severe enough to impair ability to participate in exercise based intervention
* Severe kidney disease that requires dialysis
* Develops chest pain or severe shortness of breath during 400 m walk test
* Member of household is already enrolled
* Participation in another intervention trial: participation in an observational study is permitted
* People who have lost more than 10 pounds in the past 4 months, or are on any drugs for the treatment of obesity
* Lives outside of the study site area or is planning to move in the next year
* Must be able to attend at least 6 of the first 8 weekly sessions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
100 Years
Study:
NCT00714506
Study Brief:
Protocol Section:
NCT00714506