RECRUITING

Dementia and Diabetes Prevention Program

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DiabetesDementiaPrevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Aerobic Exercise (AEx) Intervention that involves aerobic activities with in-class walking workouts and tutorials and carried out at the East Oakland Sports Center (EOSC) and Tice Creek Fitness Center (TICE). 2. Dietary counseling to support adherence to the Mediterranean-Diet Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet to encourage increased consumption of berries, green leafy and other vegetables, whole grains, nuts, fish, poultry, beans and olive oil, and to reduce consumption of fried/fast foods, red meat, whole fat cheese, sweets, butter and trans-fat margarines.

Official Title

Dementia and Diabetes Prevention Program (DDPP)

Quick Facts

Study Start:2021-05-26
Study Completion:2025-06-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04141878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sedentary (as per the Telephone Assessment of Physical Activity)
  2. * Poor diet (as per the MIND Diet Screener)
  3. * Cognitive function: absence of significant cognitive impairment as per the modified Telephone Interview for Cognitive Status (TICSm; age-, education-, and race-adjusted TICSm \>32)
  4. * Lives in a region where the DDPP interventions will be delivered
  5. * Does not plan to travel outside of the home geographic area for more than 3 months over the course of the study
  6. * Free of physical disabilities that preclude participation in the study
  7. * Willing to complete all study-related activities for 32 weeks
  8. * Willing to be randomized to either lifestyle intervention group
  1. * Age \<60
  2. * Body Mass Index (BMI) \>40
  3. * 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 hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
  4. * History of major depression within the last 12 months
  5. * History of bipolar disorder or schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria
  6. * History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria
  7. * Use of psychoactive medications within the last 3 months including tricyclic antidepressants, antipsychotics, mood-stabilizing psychotropic agents (e.g., lithium salts), psychostimulants, opiate analgesics, antiparkinsonian medications, anticonvulsant medications (except gabapentin and pregabalin for non-seizure indications), systemic corticosteroids, or medications with significant central anticholinergic activity; in the absence of major depression, stable dose use of selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors are allowed
  8. * 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 disease (e.g., angina) in the last six months, (2) Uncontrolled hypertension within the past 6 months, (3) Morbid obesity (BMI\<40), (4) History of clinically-evident stroke, (5) Clinically-significant infection within the past 30 days, (6) Significant pain or musculoskeletal disorder limiting the ability to participate safely, or (7) Clinically significant
  9. * Past or current use of insulin to treat type 2 diabetes
  10. * Serious diabetic event within 6 months of enrollment
  11. * Lung disease requiring either regular use of corticosteroids or the use of supplemental oxygen (inhaled steroids for asthma is permissible)
  12. * Renal disease
  13. * Clinically significant abnormalities in laboratory blood tests as per judgment of the Study Physician
  14. * 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 in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
  15. * History of hip fracture, joint replacement, or spinal surgery in the last 6 months
  16. * Currently receiving physical therapy or cardiopulmonary rehabilitation
  17. * History of a malabsorptive bariatric procedure (gastric bypass, biliopancreatic diversion); other bariatric procedures involving restriction (i.e., sleeve, band) are not exclusionary
  18. * For women: currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  19. * Currently incarcerated
  20. * Receiving hospice care
  21. * Adults unable to provide consent for participation
  22. * PI/Study Physician discretion regarding appropriateness of participation or concern about intervention adherence

Contacts and Locations

Study Contact

Andrea Alioto, PhD
CONTACT
925-357-6515
agalioto@ucdavis.edu
David K Johnson, PhD
CONTACT
785-342-2778
dkj@ucdavis.edu

Principal Investigator

David K Johnson, PhD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis Alzheimer's Disease Center
Walnut Creek, California, 94598
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • David K Johnson, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26
Study Completion Date2025-06-27

Study Record Updates

Study Start Date2021-05-26
Study Completion Date2025-06-27

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Dementia
  • Prevention

Additional Relevant MeSH Terms

  • Diabetes
  • Dementia