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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG051624 | U.S. NIH Grant/Contract | View source | |
| R01AG051624-02S1 | U.S. NIH Grant/Contract | View source | |
| R01AG051624-02S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study will help determine the appropriate type, amount and intensity of physical activity most beneficial for preventing weight regain after weight loss in older adults.
The investigators will use a 3-group design in 180 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women, all of whom will undergo a 9-month Weight Loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact, to test our overall hypothesis that intervening on Sedentary Behavior (SitLess) will enhance long-term Weight Loss in this age group. The diet element of the intervention is identical across groups, but groups differ by activity intervention: 1) structured, moderate-intensity, aerobic exercise (EX) (WL+EX); 2) intervening on SB throughout the day (WL+SitLess); or 3) (WL+EX+SitLess).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight loss + sitless | Other | All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. Participants will be encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
|
| Weight loss + exercise | Other | All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. Participants will be asked to perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. |
|
| Weight loss + exercise + sitless | Other | All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. Participants will be encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). Participants will be asked to perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss | Behavioral | All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Measured in clinic on the same scale | Baseline |
| Body Weight | Measured in clinic on the same scale | 6 months |
| Body Weight | Measured in clinic on the same scale | 18 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | 13 item scale used to measure fatigue over the past week with a 4-point Likert scale. The score range is 0-52 with a score of less than 30 indicating severe fatigue, and higher score denoting a better quality of life. | Baseline (0mo), 6mo, 18mo |
Inclusion Criteria:
Exclusion Criteria:
Dependent on cane or walker
Reported unintentional or intentional weight loss or gain of >5% in past 6 mo Participation in regular resistance training and/or > 20 mins/day of aerobic exercise in past 6 months
Cognitive impairment (MoCA score <22)
Low bone density (T-score < -2.3 on hip or spine scan)
Severe arthritis, or other musculoskeletal disorder
Joint replacement or other orthopedic surgery in past 6 mos
Joint replacement or other orthopedic surgery planned in next 2 years
Regular use of: growth hormones, oral steroids, weight loss medications or prescription osteoporosis meds
Current participation in other research study
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Nicklas, PhD | Wake Forest University Health Sciences | Principal Investigator |
| W. Jack Rejeski, PhD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health Sticht Center on Aging | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33135364 | Derived | Burdette JH, Laurienti PJ, Miron LL, Bahrami M, Simpson SL, Nicklas BJ, Fanning J, Rejeski WJ. Functional Brain Networks: Unique Patterns with Hedonic Appetite and Confidence to Resist Eating in Older Adults with Obesity. Obesity (Silver Spring). 2020 Dec;28(12):2379-2388. doi: 10.1002/oby.23004. Epub 2020 Nov 1. | |
| 30026128 | Derived | Fanning J, Opina MT, Leng I, Lyles MF, Nicklas BJ, Rejeski WJ. Empowered with Movement to Prevent Obesity & Weight Regain (EMPOWER): Design and methods. Contemp Clin Trials. 2018 Sep;72:35-42. doi: 10.1016/j.cct.2018.07.010. Epub 2018 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Weight Loss + Exercise + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
| FG001 | Weight Loss + Exercise | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. |
| FG002 | Weight Loss + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Weight Loss + Exercise + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight | Measured in clinic on the same scale | The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6. | Posted | Mean | Standard Deviation | kg | Baseline |
|
Baseline through month 18
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Weight Loss + Exercise + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Nicklas, MD | Wake Forest School of Medicine | 336-713-8569 | bnicklas@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2020 | Dec 9, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2020 | Aug 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic 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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|
|
| Exercise | Behavioral | Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. |
|
|
| Sitless | Behavioral | Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
|
|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a |
DAn 8 item questionnaire that assess fatigue over the past 7 days. All items are summed with the lowest possible score equaling 8 and the highest, a 40. A higher score indicates more fatigue. |
| Baseline, 6mo, 18mo |
| Pittsburg Fatigability Questionnaire | 10 item scale that assesses fatigability (fatigue in the context of a standardized task). A higher score indicates a higher performance fatigability, slower gait speed, worsening physical function. A 10 item scale that assesses fatigability (fatigue in the context of a standardized task). Score range is 0-50 with a higher score = a higher performance fatigability, slower gait speed, worsening physical function. | Baseline, 6mo, 18mo |
| Short Form 36 Item (SF-36) Health Survey | A 36 item survey of overall health broken into 8 scaled scores of vitality, physical function, pain, general health, mental health, social, physical, and emotional role functioning. Ranging from 0 to 100, the lower a person scores, the more disability. | Baseline, 6mo, 18mo |
| Self-Efficacy for Walking Scale | Self-reported measure used to determine a person's belief in their physical capability to successfully complete incremental walking distances (5-40 minutes) at a moderate pace. The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100. | Baseline, 6mo, 18mo |
| Satisfaction With Physical Function Questionnaire | A scale testing how satisfied an individual is with their physical fitness and abilities. Levels of satisfaction are rated on a 7 point scale from very dissatisfied to very satisfied. All items are then averaged to create a score ranging from -3 to 3. | Baseline, 6mo, 18mo |
| Self-Efficacy for Managing Eating Questionnaire | Used to measure self-efficacy for appropriate eating using 5 subscales (Negative Emotions, Availability, Social Pressure, Physical Discomfort, Positive Activities) of 4 items each (e.g., "I can resist eating even when high-calorie foods are available"). Item responses range from 0 (not confident) to 9 (very confident). An average score is created for each subscale and then a total score by averaging across all items. On a scale from 10 to 40, higher scores represent greater confidence in being able to restrain oneself from eating under difference contexts. | Baseline, 6mo, 18mo |
| Experiences in Close Relationships Questionnaire | Scale used to evaluate the construct of adult attachment by examining avoidance and anxiety. A person rates each statement about connection using a 7-point Likert scale which ranges from 1 (strongly disagree) to 7 (strongly agree). To obtain score, average responses from all 36 items. A score will range from 7 to 42 with a higher score representing insecure attachment. | Baseline, 6mo, 18mo |
| Mindful Attention Awareness Scale (MAAS) | 15-item questionnaire used to assess the core characteristic of mindfulness, or an awareness of and attention to what is taking place in the present. The 15 items are collected in a Likert scale, totaled, and averaged for a final score ranging from 1-7. A higher score reflects higher levels of mindfulness and a lower score is indicative of a negative emotional state. | Baseline, 6mo, 18mo |
| Power of Food Questionnaire | Scale assessing the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted). | Baseline, 6mo, 18mo |
| Perceived Stress Scale | A questionnaire used to measure the perception of stress and how often a person felt that way in the last month. Individual scores range from 0 to 40 with higher scores indicating a person perceives higher levels of stress which could lead to or correlate with negative behaviors such as stress eating or decreases in physical activity | Baseline, 6mo, 18mo |
| Food Cravings Questionnaire | 15-item measure of short-term changes in food cravings. Responses are made on a five-point Likert scale with response categories ranging from 1 (strongly disagree) to 5 (strongly agree). The scale yields a sum total from the five subscale scores, including, 1) an intense desire to eat; 2) anticipation of positive reinforcement that may result from eating; 3) anticipation of relief from negative states and feelings as a result of eating; 4) obsessive preoccupation with food or lack of control over eating; and 5) craving as a physiological state. Sum scores range from 15 to 90 with higher scores representing more frequent and intense experiences of craving food. | Baseline, 6mo, 18mo |
| Technology Survey | Administered during assessment visits to gain insight on the participants' opinion of the technology (i.e., Empower application and web-based questionnaires, any tests/emails received from the Empower team) used in the study. Examples of these open-ended questions include: 1) How useful did you find the Empower smartphone app?; 2) To what extent was the Empower app a burden to use?; 3) How difficult or easy was the app to use?; 4) How important did you feel the app was to your experience in the Empower study?; 5) What were one or two of your favorite and least favorite features of the Empower app? Questions were not scored or used in data analysis, but provided staff with an overall user opinion as well as constructive criticism in order to improve similar technologies in future studies. | 6mo, 18mo |
| Intervention Survey | Administered at assessment visits to gain inside on the participants' opinion on the group dynamic used in the first 6 months of the study. Examples of the dichotomous questions include: 1) Did you enjoy working with the staff and participants?; 2) Did you feel pressured by staff and or participants to do well in the study?; 3) Did you get along with the staff and participants in Empower?; 4) Did you feel comfortable expressing your ideas and opinions to staff members and fellow participants?; 5) Do you feel people a part of the Empower study care about you? Questions were not scored or used in data analysis, but provided staff with an overall opinion of participant experience as well as constructive criticism in order to improve similar group settings in future studies. | 6 mo, 18 mo |
| Anthropometric Measures | Three anthropometric measures at three anatomical locations are taken using a handheld measuring table with tension and recorded in centimeters. The waist measurement is taken at the narrowest part of the torso below the ribcage and above the umbilicus. The hip measurement is measured at the maximal circumference of the buttocks. The mid-thigh is taken with the knee bent to 90°, midway between the inguinal crease and the proximal border of the patella. The measurements taken at each site are averaged. A waist/hip ratio is calculated. | Baseline, 6mo, 18mo |
| Expanded Short Physical Performance Battery (eSPPB) | Consists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability. | Baseline, 6mo, 18mo |
| Treadmill Fatigability | Test is done on a treadmill to assess perceived fatigability at a given workload. Participants are asked to rate their RPE (rating of perceived exertion) just as they start walking (0 min, 2.0 mph), half way through (2.5 min, 2.0 mph), and at the end of the test (5 min, 2.0 mph). Heart rate via a heart rate monitoring watch will be recorded at these same intervals. | Baseline, 6mo, 18mo |
| Peak Aerobic Capacity (VO2) Peak | Measured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a Raise, Activate, Mobilise, Potentiate (RAMP) protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The respiratory rate, minute ventilation, breathing reserve, VO2, Validation of Carbon Dioxide Production (VCO2), respiratory exchange ratio, one metabolic equivalent (MET) level, heart rate (HR), VO2/HR, kilocalorie/minutes (Kcal/min), Rating of Perceived Exertion (RPE) and Blood pressure (BP) at test conclusion are recorded. | Baseline, 6mo, 18mo |
| Grip Strength | The Jaymar Handheld Dynamometer is used to measure grip strength in both hands. To the nearest and highest kilogram achieved, hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitation. | Baseline, 6mo, 18mo |
| Resting Metabolic Rate (RMR) | A facemask will be placed on the participant while he/she is lying on the exam table. Measures of oxygen consumption and carbon dioxide production will be collected continuously for 30 minutes and the RMR will be calculated using the Weir equation. | Baseline, 6mo, 18mo |
| Activity Monitor | Used to evaluate time spent in sedentary behavior, light, and moderate to vigorous physical activity (MVPA). An activPALâ„¢ accelerometer (PAL Technologies, Glasgow, Scotland) is worn for 7-days at each of the three assessment visits: baseline, 6-months and 18-months. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions: lying or sitting = sedentary; standing still; and stepping = light and MVPA. Data is downloaded at the end of each 7-day period and cleaned and summarized for statistical analyses. The proprietary algorithm in the activPAL software is used to generate estimates of (a) Total Daily Energy Expenditure (TDEE); (b) sedentary time during the day, (c) number of breaks in sedentary time, (d) minutes spent in light activity, and (e) number of minutes spent in MVPA. | Baseline, 6mo, 18mo |
| Ecological Momentary Assessment (EMA) | Used to determine the relationship between dynamic food variables, physical activity variables, and long-term weight loss. Prior to the start of the intervention and following the initial intervention period, participants complete week-long daily assessments. The following are the different scales and questions asked of participants: 1) Affective Valence from the Feelings Scale (scored 0 - 10 where 0 = very bad and 10 = very good). 2) Six items from the exercise-induced feelings inventory, each on a 0 ="do not feel" to 10="feel very strongly" score. Calm, peaceful, and relaxed are then averaged for a "tranquility" subscale; "fatigued, "tired" and "worn-out" are averaged for a physical exhaustion subscale. 3) Hunger was queried by "How hungry are you right now?" where 0 = not at all hungry, and 10 = very hungry. 4) An individual's craving for food was queried by "How much do you crave eating your favorite food or snack right now?" where 0 = "do not feel" and 10 = "feel very strongly". | Baseline, 6mo |
| 400 Meter Walk Test | Test is completed at a quick pace (without running) that the participant can maintain over the flat, 400 meter course. Timing begins when the participant takes his/her first step. Timing ends when the participant's whole foot crosses the line at the end of the 10th lap or the participant requests to stop. Recorded is the distance completed and time walked in minutes and seconds. | Baseline, 6mo, 18mo |
| Walking Efficiency | Used to determine the number of calories burned while walking at 2.0 mph on a treadmill with zero grade. Heart rate (HR) is measured continuously using a heart rate monitoring watch and will be recorded every minute. Blood pressure (BP) is monitored and recorded every minute. The test is terminated when the (HR) remains at a steady state (is within 5 beats per minute of the HR from the previous minute). The time to achieve steady state heart rate, the respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, and the BP at steady state are recorded. | Baseline, 6mo, 18mo |
| Visceral Fat | A visceral fat measurement is obtained through a dual-energy X-ray absorptiometry (DEXA) whole body scan in a 5-cm wide region across the entire abdomen just above the iliac crest at a level approximate with the 4th lumbar vertebrae. Mass visceral fat is measured to the nearest gram and volume to the nearest centimeter. | Baseline, 6mo, 18mo |
| Bone Mineral Density (BMD) | Hip and spine BMD is measured using specific scans of the anterior-posterior spine Lumbar vertebrae 1-Lumbar vertebrae 4 (L1-L4) and proximal femur by dual-energy X-ray absorptiometry. BMD is recorded as a t-score with a lower score indicative of less bone density and increased risk for osteoporosis. | Baseline, 6mo, 18mo |
| Cardiometabolic Risk Factors--Lab Work | An 8-hour fasting venous blood sample is collected to measure cardiometabolic changes lipoprotein lipids, C-reactive protein, HbA1c, glucose and insulin. | Baseline, 6mo, 18mo |
| Satisfaction With Physical Function | Scale used to test how satisfied participants are with their physical fitness, functional ability, and physical appearance. Participants rate their level of satisfaction on a 7-point scale from very dissatisfied to very satisfied. Average all items to create a score ranging from -3 to 3. Higher values represent greater satisfaction with physical function and importance. | Baseline, 6mo, 18mo |
| Problem with intervention |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| BG001 | Weight Loss + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
| BG002 | Weight Loss + Exercise | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education (>High School) | Count of Participants | Participants |
|
| Cognitive Status (MoCA) Score | Montreal Cognitive Assessment (MoCA) is to help determine if impaired cognition would preclude them from participating. The test is administered in approximately 10 minutes and it assesses several cognitive domains. Scores range from 0 to 30, with a lower score indicating cognitive impairment. | Mean | Standard Deviation | units on a scale |
|
| Depression (CES-D) Score | Center for Epidemiological Studies-Depression (CES-D) is administered to help exclude potential participants with clinically significant depression. The CES-D is a 20-item tool that asks subjects to rate how often over the past week they experienced symptoms associated with depression. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. A cutoff score of 16 or greater is indicative of clinical depression. | Mean | Standard Deviation | units on a scale |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist to Hip Ratio | A score is calculated by dividing waist circumference by hip circumference. High risk for men is a score greater than or equal to 0.95 and greater than or equal to 0.86 for women. | Mean | Standard Deviation | ratio |
|
| Gait Speed | Mean | Standard Deviation | m/sec |
|
| Short Physical Performance Battery (SPPB) Score | The SPPB consists of a test of balance, gait speed test, and chair stand, performed in this order to measure lower-extremity function. A score is totaled and can equal 0 to 12 with a lower score indicating poorer mobility and physical function. | Mean | Standard Deviation | units on a scale |
|
| Expanded Short Physical Performance Battery (eSPPB) Score | Consists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability. | Mean | Standard Deviation | units on a scale |
|
| Aerobic fitness | Measured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a RAMP protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The speed is set at the fastest speed that the participant can maintain for several minutes, and the grade steadily increases until the test is stopped. The respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, RPE and BP at test conclusion are recorded. | Mean | Standard Deviation | VO2peak; ml/kg/min |
|
| Resting Seated Blood Pressure--Systolic | Mean | Standard Deviation | mmHg |
|
| Resting Seated Blood Pressure Diastolic | Mean | Standard Deviation | mmHg |
|
| Self-reported comorbidity Hypertension | Count of Participants | Participants |
|
| Self-reported comorbidity Diabetes | Count of Participants | Participants |
|
| Self-reported comorbidity Sleep Apnea | Count of Participants | Participants |
|
| Self-reported comorbidity Osteoarthritis | Count of Participants | Participants |
|
| Self-reported comorbidity Osteopenia | Count of Participants | Participants |
|
| Anti-hypertensive Medication use | Count of Participants | Participants |
|
| Cholesterol-lowering Medication use | Count of Participants | Participants |
|
| Glucose control Medication use | Count of Participants | Participants |
|
| Anti-depressant/mood Medication use | Count of Participants | Participants |
|
| OG001 | Weight Loss + Exercise | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. |
| OG002 | Weight Loss + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). |
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| Primary | Body Weight | Measured in clinic on the same scale | The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6. | Posted | Mean | Standard Deviation | kg | 6 months |
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| Primary | Body Weight | Measured in clinic on the same scale | The CONSORT represents all 6 waves while our results only include data for Waves 1-4 due to COVID restrictions impacting the 18mo visit data for Waves 5 and 6. | Posted | Mean | Standard Deviation | kg | 18 months |
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| Other Pre-specified | Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | 13 item scale used to measure fatigue over the past week with a 4-point Likert scale. The score range is 0-52 with a score of less than 30 indicating severe fatigue, and higher score denoting a better quality of life. | Not Posted | Baseline (0mo), 6mo, 18mo | Participants |
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 8a | DAn 8 item questionnaire that assess fatigue over the past 7 days. All items are summed with the lowest possible score equaling 8 and the highest, a 40. A higher score indicates more fatigue. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Pittsburg Fatigability Questionnaire | 10 item scale that assesses fatigability (fatigue in the context of a standardized task). A higher score indicates a higher performance fatigability, slower gait speed, worsening physical function. A 10 item scale that assesses fatigability (fatigue in the context of a standardized task). Score range is 0-50 with a higher score = a higher performance fatigability, slower gait speed, worsening physical function. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Short Form 36 Item (SF-36) Health Survey | A 36 item survey of overall health broken into 8 scaled scores of vitality, physical function, pain, general health, mental health, social, physical, and emotional role functioning. Ranging from 0 to 100, the lower a person scores, the more disability. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Self-Efficacy for Walking Scale | Self-reported measure used to determine a person's belief in their physical capability to successfully complete incremental walking distances (5-40 minutes) at a moderate pace. The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Satisfaction With Physical Function Questionnaire | A scale testing how satisfied an individual is with their physical fitness and abilities. Levels of satisfaction are rated on a 7 point scale from very dissatisfied to very satisfied. All items are then averaged to create a score ranging from -3 to 3. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Self-Efficacy for Managing Eating Questionnaire | Used to measure self-efficacy for appropriate eating using 5 subscales (Negative Emotions, Availability, Social Pressure, Physical Discomfort, Positive Activities) of 4 items each (e.g., "I can resist eating even when high-calorie foods are available"). Item responses range from 0 (not confident) to 9 (very confident). An average score is created for each subscale and then a total score by averaging across all items. On a scale from 10 to 40, higher scores represent greater confidence in being able to restrain oneself from eating under difference contexts. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Experiences in Close Relationships Questionnaire | Scale used to evaluate the construct of adult attachment by examining avoidance and anxiety. A person rates each statement about connection using a 7-point Likert scale which ranges from 1 (strongly disagree) to 7 (strongly agree). To obtain score, average responses from all 36 items. A score will range from 7 to 42 with a higher score representing insecure attachment. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Mindful Attention Awareness Scale (MAAS) | 15-item questionnaire used to assess the core characteristic of mindfulness, or an awareness of and attention to what is taking place in the present. The 15 items are collected in a Likert scale, totaled, and averaged for a final score ranging from 1-7. A higher score reflects higher levels of mindfulness and a lower score is indicative of a negative emotional state. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Power of Food Questionnaire | Scale assessing the psychological impact of living in food-abundant environments. It measures appetite for, rather than consumption of, palatable foods, at three levels of food proximity (food available, food present, and food tasted). | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Perceived Stress Scale | A questionnaire used to measure the perception of stress and how often a person felt that way in the last month. Individual scores range from 0 to 40 with higher scores indicating a person perceives higher levels of stress which could lead to or correlate with negative behaviors such as stress eating or decreases in physical activity | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Food Cravings Questionnaire | 15-item measure of short-term changes in food cravings. Responses are made on a five-point Likert scale with response categories ranging from 1 (strongly disagree) to 5 (strongly agree). The scale yields a sum total from the five subscale scores, including, 1) an intense desire to eat; 2) anticipation of positive reinforcement that may result from eating; 3) anticipation of relief from negative states and feelings as a result of eating; 4) obsessive preoccupation with food or lack of control over eating; and 5) craving as a physiological state. Sum scores range from 15 to 90 with higher scores representing more frequent and intense experiences of craving food. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Technology Survey | Administered during assessment visits to gain insight on the participants' opinion of the technology (i.e., Empower application and web-based questionnaires, any tests/emails received from the Empower team) used in the study. Examples of these open-ended questions include: 1) How useful did you find the Empower smartphone app?; 2) To what extent was the Empower app a burden to use?; 3) How difficult or easy was the app to use?; 4) How important did you feel the app was to your experience in the Empower study?; 5) What were one or two of your favorite and least favorite features of the Empower app? Questions were not scored or used in data analysis, but provided staff with an overall user opinion as well as constructive criticism in order to improve similar technologies in future studies. | Not Posted | 6mo, 18mo | Participants |
| Other Pre-specified | Intervention Survey | Administered at assessment visits to gain inside on the participants' opinion on the group dynamic used in the first 6 months of the study. Examples of the dichotomous questions include: 1) Did you enjoy working with the staff and participants?; 2) Did you feel pressured by staff and or participants to do well in the study?; 3) Did you get along with the staff and participants in Empower?; 4) Did you feel comfortable expressing your ideas and opinions to staff members and fellow participants?; 5) Do you feel people a part of the Empower study care about you? Questions were not scored or used in data analysis, but provided staff with an overall opinion of participant experience as well as constructive criticism in order to improve similar group settings in future studies. | Not Posted | 6 mo, 18 mo | Participants |
| Other Pre-specified | Anthropometric Measures | Three anthropometric measures at three anatomical locations are taken using a handheld measuring table with tension and recorded in centimeters. The waist measurement is taken at the narrowest part of the torso below the ribcage and above the umbilicus. The hip measurement is measured at the maximal circumference of the buttocks. The mid-thigh is taken with the knee bent to 90°, midway between the inguinal crease and the proximal border of the patella. The measurements taken at each site are averaged. A waist/hip ratio is calculated. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Expanded Short Physical Performance Battery (eSPPB) | Consists of a test of balance, gait speed test, and chair stand, performed in this order. The following equipment is required for the expanded SPPB: digital stopwatch, masking tape, measuring tape, script, and a straight-backed armless chair with a hard seat. To eliminate the effect of different footwear on test performance, tests are performed in tennis shoes or comfortable walking shoes with minimal or no heels. Tests are individually scored 0-4 and then totaled for a maximal score of 12. The higher a score, the better an individual's mobility and functional ability. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Treadmill Fatigability | Test is done on a treadmill to assess perceived fatigability at a given workload. Participants are asked to rate their RPE (rating of perceived exertion) just as they start walking (0 min, 2.0 mph), half way through (2.5 min, 2.0 mph), and at the end of the test (5 min, 2.0 mph). Heart rate via a heart rate monitoring watch will be recorded at these same intervals. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Peak Aerobic Capacity (VO2) Peak | Measured during a maximal graded exercise test (GXT) to exhaustion on a treadmill using a Raise, Activate, Mobilise, Potentiate (RAMP) protocol. The GXT is used to rule out any latent coronary artery disease and to measure cardiovascular functional capacity and peak oxygen uptake. The respiratory rate, minute ventilation, breathing reserve, VO2, Validation of Carbon Dioxide Production (VCO2), respiratory exchange ratio, one metabolic equivalent (MET) level, heart rate (HR), VO2/HR, kilocalorie/minutes (Kcal/min), Rating of Perceived Exertion (RPE) and Blood pressure (BP) at test conclusion are recorded. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Grip Strength | The Jaymar Handheld Dynamometer is used to measure grip strength in both hands. To the nearest and highest kilogram achieved, hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitation. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Resting Metabolic Rate (RMR) | A facemask will be placed on the participant while he/she is lying on the exam table. Measures of oxygen consumption and carbon dioxide production will be collected continuously for 30 minutes and the RMR will be calculated using the Weir equation. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Activity Monitor | Used to evaluate time spent in sedentary behavior, light, and moderate to vigorous physical activity (MVPA). An activPALâ„¢ accelerometer (PAL Technologies, Glasgow, Scotland) is worn for 7-days at each of the three assessment visits: baseline, 6-months and 18-months. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions: lying or sitting = sedentary; standing still; and stepping = light and MVPA. Data is downloaded at the end of each 7-day period and cleaned and summarized for statistical analyses. The proprietary algorithm in the activPAL software is used to generate estimates of (a) Total Daily Energy Expenditure (TDEE); (b) sedentary time during the day, (c) number of breaks in sedentary time, (d) minutes spent in light activity, and (e) number of minutes spent in MVPA. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Ecological Momentary Assessment (EMA) | Used to determine the relationship between dynamic food variables, physical activity variables, and long-term weight loss. Prior to the start of the intervention and following the initial intervention period, participants complete week-long daily assessments. The following are the different scales and questions asked of participants: 1) Affective Valence from the Feelings Scale (scored 0 - 10 where 0 = very bad and 10 = very good). 2) Six items from the exercise-induced feelings inventory, each on a 0 ="do not feel" to 10="feel very strongly" score. Calm, peaceful, and relaxed are then averaged for a "tranquility" subscale; "fatigued, "tired" and "worn-out" are averaged for a physical exhaustion subscale. 3) Hunger was queried by "How hungry are you right now?" where 0 = not at all hungry, and 10 = very hungry. 4) An individual's craving for food was queried by "How much do you crave eating your favorite food or snack right now?" where 0 = "do not feel" and 10 = "feel very strongly". | Not Posted | Baseline, 6mo | Participants |
| Other Pre-specified | 400 Meter Walk Test | Test is completed at a quick pace (without running) that the participant can maintain over the flat, 400 meter course. Timing begins when the participant takes his/her first step. Timing ends when the participant's whole foot crosses the line at the end of the 10th lap or the participant requests to stop. Recorded is the distance completed and time walked in minutes and seconds. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Walking Efficiency | Used to determine the number of calories burned while walking at 2.0 mph on a treadmill with zero grade. Heart rate (HR) is measured continuously using a heart rate monitoring watch and will be recorded every minute. Blood pressure (BP) is monitored and recorded every minute. The test is terminated when the (HR) remains at a steady state (is within 5 beats per minute of the HR from the previous minute). The time to achieve steady state heart rate, the respiratory rate, minute ventilation, breathing reserve, VO2, VCO2, respiratory exchange ratio, MET level, HR, VO2/HR, Kcal/min, and the BP at steady state are recorded. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Visceral Fat | A visceral fat measurement is obtained through a dual-energy X-ray absorptiometry (DEXA) whole body scan in a 5-cm wide region across the entire abdomen just above the iliac crest at a level approximate with the 4th lumbar vertebrae. Mass visceral fat is measured to the nearest gram and volume to the nearest centimeter. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Bone Mineral Density (BMD) | Hip and spine BMD is measured using specific scans of the anterior-posterior spine Lumbar vertebrae 1-Lumbar vertebrae 4 (L1-L4) and proximal femur by dual-energy X-ray absorptiometry. BMD is recorded as a t-score with a lower score indicative of less bone density and increased risk for osteoporosis. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Cardiometabolic Risk Factors--Lab Work | An 8-hour fasting venous blood sample is collected to measure cardiometabolic changes lipoprotein lipids, C-reactive protein, HbA1c, glucose and insulin. | Not Posted | Baseline, 6mo, 18mo | Participants |
| Other Pre-specified | Satisfaction With Physical Function | Scale used to test how satisfied participants are with their physical fitness, functional ability, and physical appearance. Participants rate their level of satisfaction on a 7-point scale from very dissatisfied to very satisfied. Average all items to create a score ranging from -3 to 3. Higher values represent greater satisfaction with physical function and importance. | Not Posted | Baseline, 6mo, 18mo | Participants |
| 0 |
| 60 |
| 8 |
| 60 |
| 39 |
| 60 |
| EG001 | Weight Loss + Sitless | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Sitless: Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3). | 0 | 63 | 7 | 63 | 26 | 63 |
| EG002 | Weight Loss + Exercise | Weight loss: All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation. Exercise: Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week. | 0 | 60 | 4 | 60 | 25 | 60 |
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
|
| Takatsubu cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Complication of laparoscopic banding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Post Viral Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Coronary artery bypass graft | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastric sleeve procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee replacement | Surgical and medical procedures | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Brain aneurysm | Nervous system disorders | Non-systematic Assessment |
|
| Adrenal benign mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Aneurysm | Cardiac disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
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| Takatsubu cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Capsulitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Achilles tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ankle Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| TMJ pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophageal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental Crown Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| Ulcerative colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | Non-systematic Assessment |
|
| Bacterial gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | Non-systematic Assessment |
|
| Vaginal infection (fungal) | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Prostate infection | Infections and infestations | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ankle sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Foot injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Complication of laparoscopic banding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Car/Motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Car/Motor vehicle accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vaccine reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Medication Side Effect | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Retro-peritoneal mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Basal cell skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Radiculitis | Nervous system disorders | Non-systematic Assessment |
|
| Vasovagal reaction | Nervous system disorders | Non-systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | Systematic Assessment |
|
| Stenosis of branch of left middle cerebral | Nervous system disorders | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | Systematic Assessment |
|
| Light headed | Nervous system disorders | Systematic Assessment |
|
| Post viral neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythroderma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Contact dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Middle ear inflammation | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Eustachian tube infection | Ear and labyrinth disorders | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | Non-systematic Assessment |
|
| cataracts | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| retinal vascular disorder | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | Non-systematic Assessment |
|
| Hip replacement | Surgical and medical procedures | Systematic Assessment |
|
| Bilateral blepharoplasty | Surgical and medical procedures | Non-systematic Assessment |
|
| Carpal tunnel surgery | Surgical and medical procedures | Systematic Assessment |
|
| Carpal tunnel surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Cataract surgery | Surgical and medical procedures | Systematic Assessment |
|
| Cataract surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Coronary artery bypass graft | Surgical and medical procedures | Systematic Assessment |
|
| Epidural injection | Surgical and medical procedures | Non-systematic Assessment |
|
| Excision of skin cancers | Surgical and medical procedures | Systematic Assessment |
|
| Gastric sleeve procedure | Surgical and medical procedures | Systematic Assessment |
|
| Joint injection | Surgical and medical procedures | Non-systematic Assessment |
|
| Saphenous vein ablation | Surgical and medical procedures | Non-systematic Assessment |
|
| Phlebotomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Knee replacement | Surgical and medical procedures | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | Systematic Assessment |
|
| Achilles tendon repair | Surgical and medical procedures | Systematic Assessment |
|
| Removal of ingrown toe nail | Surgical and medical procedures | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Brain aneurysm | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Gallbladder pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Adrenal benign mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |