DiabetesDDPPNCT04141878
Dementia and Diabetes Prevention Program
A study testing Aerobic Exercise and Diet Skills in people with Diabetes and Dementia, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Aerobic Exercise and Diet Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 27 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 randomized to either lifestyle intervention group
Who cannot join
- 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 hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
- 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
Show all 22Show fewer
- 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
- 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
- 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 in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis Alzheimer's Disease Center
Walnut Creek, California, 94598
Andrea Alioto, PhD, 925-357-6515, agalioto@ucdavis.edu
David K Johnson, PhD, 785-342-2778, dkj@ucdavis.edu
About this study
Official title: Dementia and Diabetes Prevention Program (DDPP)
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:
- 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).
- 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.
Read the detailed description
The 8-month diet and AEx regimens used here are theoretically motivated by implementation science and use the best available practices to treat multisystemic disabling processes. The recent Centers for Disease Control (CDC) review of Diabetes Prevention Program (DPP) implementation literature found that 1 hour per week is the optimal length and frequency to balance cost and attentional demands of the participants. DPP class structure generally involves a 10-min weigh-in, a discussion of adherence to personal weight loss and exercise goals, formal DPP content delivery, and lastly a discussion of barriers to adherence. Diet module content focuses on calorie restriction by altering the composition of participants' meals. These goals include reducing trans-fats, saturated fats, sodium, and carbohydrates and increasing fruits, vegetables, whole grains, and fiber. Participants set weight reduction goals for themselves with personalized goals between 5% and 10% of total body weight dependent on the participant's level of obesity - effectively replacing prepared foods with traditional (Mediterranean) diet.
Because cognitive abilities do not appear to change without a corresponding improvement in cardio respiratory (CR) fitness, the 8-month AEx module content optimizes CR fitness improvement with in-class walking workouts and tutorials. All health instructors at TICE and EOSC will have at least an Associates level degree in exercise physiology and be required to have personal training certification. They will always be under the direct supervision of the PI. Direct supervision of the participants by these health instructors will occur for all exercise sessions until the weekly duration target of 150 minutes a week is reached (Week 6). We introduce more flexibility in scheduling exercise when the participant is consistently and safely meeting their goals by allowing unsupervised exercise sessions at the facility when exercise trainers may not be available (i.e. early morning, nights, and weekends). Participants are still required to have at least one directly supervised exercise session per week to maintain contact with program staff and encourage adherence to the program. Unsupervised exercise sessions are conducted similarly to supervised exercise and session data will be reviewed by the exercise instructor at the weekly supervised session.
Per a well-developed literature on DPP best practices,159,160 we will limit intervention class sizes to about 20 people. Over the course of 5 years, we will run 30 to 35 full DPP groups, each session meeting weekly for 20 consecutive weeks of diet-focused or AEx-focused intervention.
Previous studies suggest that salivary hormones such as cortisol, alpha-amylase and testosterone all measure glucocorticoid (GC) sensitivity, a potent biomarker of age-related stress. We will measure three stress markers in spit before and after a participant exercises during the 6-minute walk challenge at baseline and at each follow-up visit. Because better fitness is believed to improve one's reaction to stressful events, changes in these hormones may reflect the adaptation of a person's ability to cope with emotional and physical stress as they become more cardiorespiratory fit.
- Being tested
- Aerobic Exercise, Diet Skills
- Keywords
- Diabetes, Dementia, Prevention
- Medical subject headings
- Diabetes Mellitus, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Participants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise may vary, but will primarily focus on walking tutorials.
Diet SkillsBehavioural
Participants will attend weekly classes focused on incorporating heart healthy foods into their existing diets. Calories will be restricted, and portion control will be taught with the goal of losing body weight. Hands-on skills will be taught for preparing healthy home-cooked meals by professional chefs.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Active comparator | Participants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise will vary, but will primarily focus on in-class walking tutorials. Participants will work with a Personal Trainer to create their own physical activity program that will fit their needs and schedule. The Personal Trainer will supervise the participants directly for the first 6 weeks. Once participants are consistently and safely meeting their goals, their Personal Trainer will allow unsupervised exercise sessions. Receives: Behavioral: Aerobic Exercise |
| Diet Skills Group | Active comparator | Participants will attend weekly classes focused on incorporating heart healthy foods (e.g., fruits and vegetables) into their existing dietary plan. We will ask them to limit the number of calories they take in and will show them how to use portion control with the goal of losing body weight. Participants will also learn hands-on skills for preparing healthy meals at home in cooking classes led by professional chefs. Receives: Behavioral: Diet Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DDPP Neuropsychological Test Battery
Cognitive Performance
Measured: Change from Baseline to Month 4
Secondary outcomes (5)
Change in 6-Minute Walk Test
A reliable estimate of cardiorespiratory fitness that measures the maximum distance a person can walk in 6 minutes and the change in heart rate from start to finish.
Measured: Change from Baseline to Month 4
Change in Hand-Grip Strength
Grip strength is determined using a hand-held dynamometer and measured in kilograms (kg) of isometric force. Participants are then required to squeeze the hand-held dynamometer inner and outer grips towards each other as hard as possible without bending the elbow, while remaining seated.
Measured: Change from Baseline to Month 4
Change in Chair Rise
Measure of lower body strength. Participants are seated in a chair without armrests and instructed to rise from the chair to a stand and sit down again. The process is repeated as many times as possible for 30 seconds.
Measured: Change from Baseline to Month 4
Change in Body Mass Index (BMI)
weight, height, and waist circumference measurements are collected and BMI calculated.
Measured: Change from Baseline to Month 4
Change in Glycated Hemoglobin (Hemoglobin A1C)
hemoglobin A1C will be analyzed using the University of California, Davis (UCD) Alzheimer's Disease Center (ADC) site Finger stick whole blood analyzer
Measured: Change from Baseline to Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start26 May 2021
- Primary completion27 Jun 2027 (estimated)
- Study completion27 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to either the Aerobic Exercise Group or the Diet Skills Group. Each participant will eventually complete both groups.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- East Oakland Sports Center, Tice Creek Fitness Center
- Responsible party
- Sponsor
- Investigators
- David K Johnson, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141878
- Sponsor's protocol ID
- 1464339
- Acronym
- DDPP
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia and Diabetes Prevention Program (DDPP)
- ClinicalTrials.gov ID
- NCT04141878
- Acronym / sponsor ID
- DDPP / 1464339
- Keywords
- Diabetes, Dementia, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- East Oakland Sports Center, Tice Creek Fitness Center
- Study start
- 26 May 2021 (actual)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 27 Jun 2027 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
Detailed description
The 8-month diet and AEx regimens used here are theoretically motivated by implementation science and use the best available practices to treat multisystemic disabling processes. The recent Centers for Disease Control (CDC) review of Diabetes Prevention Program (DPP) implementation literature found that 1 hour per week is the optimal length and frequency to balance cost and attentional demands of the participants. DPP class structure generally involves a 10-min weigh-in, a discussion of adherence to personal weight loss and exercise goals, formal DPP content delivery, and lastly a discussion of barriers to adherence. Diet module content focuses on calorie restriction by altering the composition of participants' meals. These goals include reducing trans-fats, saturated fats, sodium, and carbohydrates and increasing fruits, vegetables, whole grains, and fiber. Participants set weight reduction goals for themselves with personalized goals between 5% and 10% of total body weight dependent on the participant's level of obesity - effectively replacing prepared foods with traditional (Mediterranean) diet.
Because cognitive abilities do not appear to change without a corresponding improvement in cardio respiratory (CR) fitness, the 8-month AEx module content optimizes CR fitness improvement with in-class walking workouts and tutorials. All health instructors at TICE and EOSC will have at least an Associates level degree in exercise physiology and be required to have personal training certification. They will always be under the direct supervision of the PI. Direct supervision of the participants by these health instructors will occur for all exercise sessions until the weekly duration target of 150 minutes a week is reached (Week 6). We introduce more flexibility in scheduling exercise when the participant is consistently and safely meeting their goals by allowing unsupervised exercise sessions at the facility when exercise trainers may not be available (i.e. early morning, nights, and weekends). Participants are still required to have at least one directly supervised exercise session per week to maintain contact with program staff and encourage adherence to the program. Unsupervised exercise sessions are conducted similarly to supervised exercise and session data will be reviewed by the exercise instructor at the weekly supervised session.
Per a well-developed literature on DPP best practices,159,160 we will limit intervention class sizes to about 20 people. Over the course of 5 years, we will run 30 to 35 full DPP groups, each session meeting weekly for 20 consecutive weeks of diet-focused or AEx-focused intervention.
Previous studies suggest that salivary hormones such as cortisol, alpha-amylase and testosterone all measure glucocorticoid (GC) sensitivity, a potent biomarker of age-related stress. We will measure three stress markers in spit before and after a participant exercises during the 6-minute walk challenge at baseline and at each follow-up visit. Because better fitness is believed to improve one's reaction to stressful events, changes in these hormones may reflect the adaptation of a person's ability to cope with emotional and physical stress as they become more cardiorespiratory fit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to either the Aerobic Exercise Group or the Diet Skills Group. Each participant will eventually complete both groups.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Active comparator | Behavioral: Aerobic ExerciseParticipants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise will vary, but will primarily focus on in-class walking tutorials. Participants will work with a Personal Trainer to create their own physical activity program that will fit their needs and schedule. The Personal Trainer will supervise the participants directly for the first 6 weeks. Once participants are consistently and safely meeting their goals, their Personal Trainer will allow unsupervised exercise sessions. |
| Diet Skills Group | Active comparator | Behavioral: Diet SkillsParticipants will attend weekly classes focused on incorporating heart healthy foods (e.g., fruits and vegetables) into their existing dietary plan. We will ask them to limit the number of calories they take in and will show them how to use portion control with the goal of losing body weight. Participants will also learn hands-on skills for preparing healthy meals at home in cooking classes led by professional chefs. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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 hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise may vary, but will primarily focus on walking tutorials. | Behavioural | Aerobic Exercise Group |
| Diet SkillsParticipants will attend weekly classes focused on incorporating heart healthy foods into their existing diets. Calories will be restricted, and portion control will be taught with the goal of losing body weight. Hands-on skills will be taught for preparing healthy home-cooked meals by professional chefs. | Behavioural | Diet Skills Group |
Primary outcome
Change in DDPP Neuropsychological Test Battery
Time frame: Change from Baseline to Month 4
Cognitive Performance
5 secondary outcomes
Change in 6-Minute Walk Test
Time frame: Change from Baseline to Month 4
Change in Hand-Grip Strength
Time frame: Change from Baseline to Month 4
Change in Chair Rise
Time frame: Change from Baseline to Month 4
Change in Body Mass Index (BMI)
Time frame: Change from Baseline to Month 4
Change in Glycated Hemoglobin (Hemoglobin A1C)
Time frame: Change from Baseline to Month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David K Johnson, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Diet Skills in people with Diabetes and Dementia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Alioto, PhD (925-357-6515, agalioto@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DDPP Neuropsychological Test Battery (time frame: Change from Baseline to Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.