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Dementia and Diabetes Prevention Program (DDPP)

Primary Purpose

Diabetes, Dementia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic Exercise

Diet Skills

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetes, Dementia, Prevention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 randomized to either lifestyle intervention group

Exclusion Criteria:

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
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

Sites / Locations

University of California, Davis Alzheimer's Disease CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Aerobic Exercise Group

Diet Skills Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in DDPP Neuropsychological Test Battery

Cognitive Performance

Secondary Outcome Measures

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.

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.

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.

Change in Body Mass Index (BMI)

weight, height, and waist circumference measurements are collected and BMI calculated.

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

Full Information

NCT ID

NCT04141878

First Posted

October 15, 2019

Last Updated

May 10, 2023

Sponsor

University of California, Davis

Collaborators

East Oakland Sports Center, Tice Creek Fitness Center

1. Study Identification

Unique Protocol Identification Number

NCT04141878

Brief Title

Dementia and Diabetes Prevention Program

Acronym

DDPP

Official Title

Dementia and Diabetes Prevention Program (DDPP)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 26, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

East Oakland Sports Center, Tice Creek Fitness Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Dementia

Keywords

Diabetes, Dementia, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Masking Description

There is no masking in this study. Everyone will know whether the participant is currently participating in the Aerobic Exercise Group or the Diet Skills Group. All participants will eventually complete both groups.

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Exercise Group

Arm Type

Active Comparator

Arm Description

Arm Title

Diet Skills Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Diet Skills

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in DDPP Neuropsychological Test Battery

Description

Cognitive Performance

Time Frame

Change from Baseline to Month 4

Secondary Outcome Measure Information:

Title

Change in 6-Minute Walk Test

Description

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.

Time Frame

Change from Baseline to Month 4

Title

Change in Hand-Grip Strength

Description

Time Frame

Change from Baseline to Month 4

Title

Change in Chair Rise

Description

Time Frame

Change from Baseline to Month 4

Title

Change in Body Mass Index (BMI)

Description

weight, height, and waist circumference measurements are collected and BMI calculated.

Time Frame

Change from Baseline to Month 4

Title

Change in Glycated Hemoglobin (Hemoglobin A1C)

Description

hemoglobin A1C will be analyzed using the University of California, Davis (UCD) Alzheimer's Disease Center (ADC) site Finger stick whole blood analyzer

Time Frame

Change from Baseline to Month 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 randomized to either lifestyle intervention group Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Alioto, PhD

Phone

925-357-6515

agalioto@ucdavis.edu

First Name & Middle Initial & Last Name or Official Title & Degree

David K Johnson, PhD

Phone

785-342-2778

dkj@ucdavis.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David K Johnson, PhD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis Alzheimer's Disease Center

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Alioto, PhD

Phone

925-357-6515

agalioto@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

David K Johnson, PhD

Phone

785-342-2778

dkj@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

David K Johnson, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to make individual participant data available to other researchers.

Links:

URL

https://studypages.com/s/dementia-diabetes-prevention-program-ddpp-940291/

Description

Learn more or sign up for the study here!

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Dementia and Diabetes Prevention Program

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