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Prevention study for Diabetes
Official title Dementia and Diabetes Prevention Program
ClinicalTrials.gov ID: NCT04141878
What this study is testing
- What it's testing
- This is a multicenter, randomized 2-arm clinical trial of two lifestyle interventions varying in intensity and format, in 400 older African American and non-Hispanic whites at increased risk of cognitive decline and dementia in the East San Francisco Bay Area. The trial will include two lifestyle interventions that differ in intensity and format: 1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Sedentary (as per the Telephone Assessment of Physical Activity)
- Poor diet (as per the MIND Diet Screener)
- Cognitive function: absence of significant cognitive impairment as per the modified Telephone Interview for Cognitive Status (TICSm; age-...
- Lives in a region where the DDPP interventions will be delivered
- Does not plan to travel outside of the home geographic area for more than 3 months over the course of the study
You likely can't join if
- Age \<60
- Body Mass Index (BMI) \>40
- Any significant neurologic disease, including any form of dementia, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain...
- History of major depression within the last 12 months
- History of bipolar disorder or schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria
- History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria
See the full eligibility criteria
- Sedentary (as per the Telephone Assessment of Physical Activity)
- Poor diet (as per the MIND Diet Screener)
- Cognitive function: absence of significant cognitive impairment as per the modified Telephone Interview for Cognitive Status (TICSm; age-, education-, and race-adjusted TICSm \>32)
- Lives in a region where the DDPP interventions will be delivered
- Does not plan to travel outside of the home geographic area for more than 3 months over the course of the study
- Free of physical disabilities that preclude participation in the study
- Willing to complete all study-related activities for 32 weeks
- Willing to be assigned by chance to either lifestyle intervention group
- Age \<60
- Body Mass Index (BMI) \>40
- Any significant neurologic disease, including any form of dementia, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural...
- History of major depression within the last 12 months
- History of bipolar disorder or schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria
- History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria
- Use of psychoactive medications within the last 3 months including tricyclic antidepressants, antipsychotics, mood-stabilizing psychotropic agents (e.g., lithium salts), psychostimulants, opiate analgesics...
- Health profiles that would jeopardize their safety to participate: (Screen failures will be referred immediately to a physician for medical examination): (1) Myocardial infarction or symptoms of unstable coronary artery...
- Past or current use of insulin to treat type 2 diabetes
- Serious diabetic event within 6 months of enrollment
- Lung disease requiring either regular use of corticosteroids or the use of supplemental oxygen (inhaled steroids for asthma is permissible)
- Renal disease
- Clinically significant abnormalities in laboratory blood tests as per judgment of the Study Physician
- History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma...
- History of hip fracture, joint replacement, or spinal surgery in the last 6 months
- Currently receiving physical therapy or cardiopulmonary rehabilitation
- History of a malabsorptive bariatric procedure (gastric bypass, biliopancreatic diversion); other bariatric procedures involving restriction (i.e., sleeve, band) are not exclusionary
- For women: currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- Currently incarcerated
- Receiving hospice care
- Adults unable to provide consent for participation
- PI/Study Physician discretion regarding appropriateness of participation or concern about intervention adherence
The study team makes the final eligibility decision.
Where it's taking place
- Walnut Creek, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Walnut Creek, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.