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| Name | Class |
|---|---|
| East Oakland Sports Center | UNKNOWN |
| Tice Creek Fitness Center | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DDPP Neuropsychological Test Battery | Cognitive Performance | Change from Baseline to Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from Baseline to Month 4 |
| Change in Hand-Grip Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Alioto, PhD | Contact | 925-357-6515 | agalioto@ucdavis.edu | |
| David K Johnson, PhD | Contact | 785-342-2778 | dkj@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| David K Johnson, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Alzheimer's Disease Center | Recruiting | Walnut Creek | California | 94598 | United States |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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We do not plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Subjects will be randomized to either the Aerobic Exercise Group or the Diet Skills Group. Each participant will eventually complete both groups.
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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.
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| Diet Skills | Behavioral | 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. |
|
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 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. | Change from Baseline to Month 4 |
| Change in Body Mass Index (BMI) | weight, height, and waist circumference measurements are collected and BMI calculated. | 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 | Change from Baseline to Month 4 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |