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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG058725 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The first phase of the study is a feasibility survey of eligible participants, completed prior to initiating the intervention. The intervention consists of a 6-month 1:1 randomized trial with a waitlist control that recruits 120 older AA women. The rationale for these aims is that the successful completion is expected to provide evidence that a community-based, peer-led weight loss program with a national infrastructure can help a vulnerable, underserved population lose weight and improve their physical function. For older, obese, frail individuals, this could improve their CVD risk factors, quality of life, enhance their health; reduce their healthcare utilization, illness, and disability; and decrease their adverse geriatric outcomes. After completing these aims, the investigators expect that they will have proven that the community-based, peer-led weight loss program can improve both weight and physical function among older, obese AA women. This also could help other demographic groups with obesity and poor physical function. Eventually, it could help older adults maintain their health and independence in the community
Older African American (AA) women have the highest prevalence of both obesity and frailty. In academic, expert-led interventions, obese, frail, older individuals both lost weight and improved their physical function. However, because of high personnel costs and nonexistent nationwide infrastructure, large-scale implementation of these interventions is impractical. The long-term goals are to eliminate the health disparities of obesity and frailty in older AA women. This proposal's overall objective is to determine the effects of a low-cost, community-based, peer-led weight loss program with a national infrastructure on obesity, physical function, and healthcare utilization in older AA women. To treat obesity and frailty in older AA women, it is critical to test a weight loss intervention that 1) has preliminary evidence of benefit; 2) is acceptable to older AA women; 3) is affordable; and 4) can be broadly disseminated. Take Off Pounds Sensibly (TOPS) is a national, nonprofit, community-based, peer-led weight loss program that meets these criteria. First, the applicant's retrospective database analyses of TOPS showed two important results: 1) Participants who renew their annual membership lose and maintain significant weight loss (SWL) for up to 7 years; and 2) Compared to their younger counterparts, older women are more likely to achieve SWL. Second, the applicant started three TOPS chapters for older AA women in a successful pilot study. Though the study ended in 2012, one of the chapters is still active almost 6 years later. Third, TOPS is affordable; it only costs $120 annually. Finally, TOPS has a nationwide infrastructure with chapters in all 50 states. Since obese, frail, older individuals in academic, expert-led weight loss interventions can improve their physical function, the central hypothesis is that a low cost, community-based, peer-led weight loss program with a national infrastructure can provide SWL, improved physical function, and lower healthcare utilization for AA women, an underserved, vulnerable population. The rationale for the proposed research is that TOPS and academic, expert-led weight loss interventions share components critical to successful weight loss; therefore, TOPS can deliver similar outcomes. The central hypothesis will be tested by pursuing the following aims in obese, frail, older AA women: Determine the effect of TOPS on 1) weight change and cardiovascular disease risk factors; 2) physical function and quality of life; and 3) healthcare utilization. This project is innovative because it uses a "community to academia" approach to treat the health disparities; our study population focuses on older AA women with decreased physical function; our outcomes focus on weight, physical function, and healthcare utilization; and our unique study settings. The proposed research is significant because determining the real-world effectiveness of the TOPS program and its impact on weight, physical function, and healthcare utilization in AA women can have a widespread impact on the older population at large. Thus, it has the potential to reduce adverse geriatric outcomes among all older individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Take Off Pounds Sensibly (TOPS) | Experimental | This group will receive TOPS intervention at the start of the study. |
|
| Waitlist control | Other | This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Take of Pounds Sensibly (TOPS) | Behavioral | Dietitian-facilitated classes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Percent of body weight change over 6 months | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (BP) | A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| Diastolic Blood Pressure (BP) | A measure of cardiovascular disease (CVD) risk. |
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Inclusion Criteria:
Conditional Inclusion Criteria:
Participants with type 2 diabetes on insulin or sulfonylureas will be allowed to participate in the study only if their providers agree to manage the changing medications requirements associated with possible weight loss by signing a "Permission to Participate" form. It is important to include patients with type 2 diabetes on insulin and sulfonylureas because these participants can benefit greatly from weight loss.
Exclusion Criteria:
African-American women
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| Name | Affiliation | Role |
|---|---|---|
| Nia S Mitchell, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27707 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39832532 | Derived | Mitchell NS, North R, Hung A, Porter Starr KN, Bales CW, Coffman CJ. Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial. Contemp Clin Trials. 2025 Mar;150:107815. doi: 10.1016/j.cct.2025.107815. Epub 2025 Jan 18. |
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Participants from the feasibility period were not considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Take Off Pounds Sensibly (TOPS) | This group will receive TOPS intervention at the start of the study. Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes |
| FG001 | Waitlist Control | This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community. Waitlist Control: At end of study, offered peer-led classes to attend. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Take Off Pounds Sensibly (TOPS) | This group will receive TOPS intervention at the start of the study. Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes |
| BG001 | Waitlist Control |
| 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 | Weight Change | Percent of body weight change over 6 months | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | percentage of body weight | Baseline to 6 months |
|
Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
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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 | Take Off Pounds Sensibly (TOPS) | This group will receive TOPS intervention at the start of the study. Take of Pounds Sensibly (TOPS): Dietician-facilitated classes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pacemaker implant | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nia Schwann Mitchell, MD, MPH | Duke University | 919-668-7202 | nia.s.mitchell@duke.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 | Dec 15, 2025 | Jan 2, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2023 | Jul 11, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Waitlist Control | Other | At end of study, offered peer-led classes to attend. |
|
| Baseline, 3 months, 6 months |
| Waist Circumference (WC) | A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| Hemoglobin A1c (HA1c) | Percentage of hemoglobin that is coated with glucose. A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| HDL (High-Density Lipoprotein) Cholesterol | A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| LDL (Low-Density Lipoprotein) Cholesterol, Calculated | A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| LDL (Low-Density Lipoprotein) Cholesterol, Direct | A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| Triglycerides | A measure of cardiovascular disease (CVD) risk. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 3 months, 6 months |
| Healthcare Utilization as Measured by Number of Primary Care Visits | Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months). | Baseline, 3 months, 6 months |
| Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits | Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months). | Baseline, 3 months, 6 months |
| Healthcare Utilization as Measured by Number of Participants With Hospitalizations | Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months). | Baseline, 3 months, 6 months |
| Physical Function as Measured by Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. Scores range from zero to 12 possible points. Lower scores are associated with lower function. | Baseline, 3 months, 6 months |
| Physical Function as Measured by 8-ft Up and Go | The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving. Higher times are associated with worse physical function. | Baseline, 3 months, 6 months |
| Physical Function as Measured by Isometric Hand Grip, Right Hand | Decreased grip strength is a predictor of adverse outcomes in older adults. | Baseline, 3 months, 6 months |
| Physical Function as Measured by Isometric Hand Grip, Left Hand | Decreased grip strength is a predictor of adverse outcomes in older adults. | Baseline, 3 months, 6 months |
| Physical Function as Measured by 30 Second Chair Stands | Counts the number of times a participant goes from sitting to standing in 30 seconds. Tests leg strength and endurance. Higher number associated with higher leg strength and endurance. | Baseline, 3 months, 6 months |
| Physical Function as Measured by 6 Minute Walk Test | Measures distance walked in 6 minutes and assesses aerobic capacity and endurance. Higher number indicates higher aerobic capacity and endurance. | Baseline, 3 months, 6 months |
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Systolic Blood Pressure (BP) | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Diastolic Blood Pressure (BP) | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Waist Circumference (WC) | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | cm | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Hemoglobin A1c (HA1c) | Percentage of hemoglobin that is coated with glucose. A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | percent glycated hemoglobin | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | HDL (High-Density Lipoprotein) Cholesterol | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | LDL (Low-Density Lipoprotein) Cholesterol, Calculated | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | LDL (Low-Density Lipoprotein) Cholesterol, Direct | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Triglycerides | A measure of cardiovascular disease (CVD) risk. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
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|
|
| Secondary | Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
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|
|
| Secondary | Healthcare Utilization as Measured by Number of Primary Care Visits | Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months). | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | visits | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits | Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months). | Participants with data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Healthcare Utilization as Measured by Number of Participants With Hospitalizations | Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months). | Participants with data collected at each timepoint. | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Physical Function as Measured by Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. Scores range from zero to 12 possible points. Lower scores are associated with lower function. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Physical Function as Measured by 8-ft Up and Go | The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving. Higher times are associated with worse physical function. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | seconds | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Physical Function as Measured by Isometric Hand Grip, Right Hand | Decreased grip strength is a predictor of adverse outcomes in older adults. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | kg | Baseline, 3 months, 6 months |
|
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|
|
| Secondary | Physical Function as Measured by Isometric Hand Grip, Left Hand | Decreased grip strength is a predictor of adverse outcomes in older adults. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | kg | Baseline, 3 months, 6 months |
|
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|
|
| Secondary | Physical Function as Measured by 30 Second Chair Stands | Counts the number of times a participant goes from sitting to standing in 30 seconds. Tests leg strength and endurance. Higher number associated with higher leg strength and endurance. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | chair stands | Baseline, 3 months, 6 months |
|
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| Secondary | Physical Function as Measured by 6 Minute Walk Test | Measures distance walked in 6 minutes and assesses aerobic capacity and endurance. Higher number indicates higher aerobic capacity and endurance. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | meters | Baseline, 3 months, 6 months |
|
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|
|
| 0 |
| 58 |
| 2 |
| 58 |
| 19 |
| 58 |
| EG001 | Waitlist Control | This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community. Waitlist Control: At end of study, offered peer-led classes to attend. | 0 | 58 | 3 | 58 | 16 | 58 |
| Hospital stay for flu | Infections and infestations | Systematic Assessment |
|
| Blood transfusion | Surgical and medical procedures | Systematic Assessment |
|
| Heel infection | Infections and infestations | Systematic Assessment |
|
| Surgery for heel infection | Surgical and medical procedures | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder surgery after fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Root canal | Surgical and medical procedures | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Sore throat | Infections and infestations | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pelvic mass | Reproductive system and breast disorders | Systematic Assessment |
|
| Breast concerns | Reproductive system and breast disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Shortness of breath | Cardiac disorders | Systematic Assessment |
|
| Dehydration | Cardiac disorders | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| E Coli infection | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Allergy | Immune system disorders | Systematic Assessment |
|
| Other | Ear and labyrinth disorders | Systematic Assessment |
|
| Increased blood pressure | Cardiac disorders | Systematic Assessment |
|
| General disorders | 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 |
| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 3 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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