Start: May 26, 2021
End: June 27, 2024
What Is This Study About?
This study will assess the effectiveness of two different lifestyle interventions to reduce dementia and diabetes risk. Participants will be randomly assigned to either the aerobic exercise program or the diet skills program. Participants in the aerobic exercise program will work-out at a fitness center with a personal trainer three times per week. Participants in the diet skills program will attend weekly classes focused on eating heart healthy foods, portion control, and learning hands-on skills to prepare healthy meals at home. After four months, participants will switch groups and complete the other lifestyle intervention for another four months. At the start and end of each program, participants will complete memory tests, a physical examination, and provide blood samples.
Do I Qualify To Participate in This Study?
- Living a sedentary lifestyle
- Poor diet, based on a survey at study screening
- No serious cognitive impairment, based on a screening telephone interview
- No plans to travel outside of the home geographic area for more than three months during the study
Must NOT have:
- Any physical disabilities that could interfere or prevent participation in the study
- Obesity with a body mass index > 40
- Diagnosis of any serious medical illness or condition that could interfere with the study, including:
- Neurological disease, including dementia, Parkinson's disease, Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorders, stroke, multiple sclerosis, or history of serious head trauma with persistent neurological symptoms or known brain structure abnormalities
- Major depression within the last 12 months
- History of bipolar disorder or schizophrenia
- Lung disease requiring regular use of corticosteroids or supplemental oxygen (inhaled steroids for asthma are allowed)
- Kidney disease
- Heart attack, symptoms of unstable coronary artery disease (e.g., angina), or uncontrolled high blood pressure in the past six months
- Serious infection within the past month
- Pain or musculoskeletal disorder that interferes with study participation
- Malignant cancer within two years prior to study screening (certain skin, cervical, and prostate cancers that have not spread are allowed)
- Hip fracture, joint replacement, or spinal surgery within the past six months
- History of alcohol or substance abuse or dependence within the past two years
- Treatment with a psychiatric medication within three months before starting the study, including:
- Tricyclic antidepressants, antipsychotics, mood-stabilizing psychotropic agents (e.g., lithium salts, psychostimulants, opiate analgesics)
- Anti-parkinsonian medications, anti-convulsant medications (except gabapentin and pregabalin for non-seizure indications)
- Systemic corticosteroids or medications with significant central anticholinergic activity
- If taking selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors for mild to moderate depression, dosage must be stable
- Past or current use of insulin to treat type 2 diabetes
- Serious diabetic event within six months of study screening
- Serious blood test abnormalities at study screening
- Currently receiving physical therapy or cardiopulmonary rehabilitation
- History of bariatric surgery, including gastric bypass and biliopancreatic diversion; restriction surgeries (i.e., gastric sleeve or band) are allowed
- Women must not be currently pregnant, pregnant within the past six months, or planning to become pregnant within the next six months
- Living in a prison
- Receiving hospice care
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Andrea Alioto, PhD
David K Johnson, PhD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: University of California, Davis
East Oakland Sports Center
Tice Creek Fitness Center
Source: ClinicalTrials.gov ID: NCT04141878