Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23HL118133 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.
The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Program Intervention | Experimental | The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes. In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. |
|
| Usual Care Group | Other | Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral | Physical Activity Program Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Objective Physical Activity at 4 Months | ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values. | Baseline, 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Physical Function at 4 Months | Measured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed. | Baseline, 4 Months |
| Change From Baseline in Physical Function at 4 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy Huebschmann, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35312788 | Derived | Huebschmann AG, Glasgow RE, Leavitt IM, Chapman K, Rice JD, Lockhart S, Stevens-Lapsley JE, Reusch JEB, Dunn AL, Regensteiner JG. Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial. Transl Behav Med. 2022 May 25;12(4):601-610. doi: 10.1093/tbm/ibac014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 55 people were determined to be eligible for this study, however 5 of them withdrew prior to randomization. This explains the discrepancy between Protocol section (n=55) and Participant Flow Module (n=50).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Program Intervention | The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes. In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. Physical Activity: Physical Activity Program Intervention |
| FG001 | Usual Care Group | Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Program Intervention | The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes. In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. Physical Activity: Physical Activity Program Intervention |
| 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 | Change From Baseline in Objective Physical Activity at 4 Months | ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values. | Posted | Mean | 95% Confidence Interval | steps/week | Baseline, 4 Months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Activity Program Intervention | The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes. In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. Physical Activity: Physical Activity Program Intervention |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated Medical Issue | Psychiatric disorders | Systematic Assessment | Major depressive episode with suicidal ideation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Huebschmann | University of Colorado - Anschutz Medical Campus | 3037242268 | amy.huebschmann@cuanschutz.edu |
Not provided
| 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 | Jun 19, 2015 | Aug 12, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D015438 | Health Behavior |
| D003924 | Diabetes Mellitus, Type 2 |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaires | Behavioral | Participants in the usual care arm will receive three mailings during the intervention phase. |
|
Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise. These data are presented as the change from baseline values where higher values indicate better physical function (scoring range 0-12). |
| Baseline, 4 Months |
| BG001 | Usual Care Group | Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Hemoglobin A1c (%) | Mean | Standard Deviation | percent |
|
| Systolic Blood Pressure (mm/Hg) | Mean | Standard Deviation | mm/Hg |
|
| Diastolic Blood Pressure (mm/Hg) | Mean | Standard Deviation | mm/Hg |
|
| Baseline fitness level (VO2peak, ml/kg/min) | Mean | Standard Deviation | ml/kg/min |
|
| Depressive symptoms by Center for Epidemiologic Studies Depression Scale (CES-D) | Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | Mean | Standard Deviation | points |
|
| Endurance Confidence Survey | This survey measures confidence in ability to do different things related to physical activity and endurance. The scoring ranges from 0-1,200, with higher scores indicating greater confidence. | Mean | Standard Deviation | points |
|
| Confidence: Motivation to conduct physical activity(PA) amidst competing demands | This survey measures confidence in ability to motivate oneself in order to perform physical activity amidst competing demands. The scoring ranges from 0-60, with higher scores indicating greater confidence. | Mean | Standard Deviation | points |
|
| Confidence: Self-efficacy for physical activity in presence of diabetes | This survey measures confidence in ability to perform physical activity with a type 2 diabetes diagnosis. The scoring ranges from 0-800, with higher scores indicating greater confidence. | Mean | Standard Deviation | points |
|
| % participants with baseline functional impairment | This is the percentage of participants in each group with functional impairment at entry in the study as measured by the short physical performance battery (SPPB) test. Impairment is identified by an SPPB score of <12, with higher values indicating less functional impairment. | Count of Participants | Participants |
|
| OG001 | Usual Care Group | Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase. |
|
|
| Secondary | Change From Baseline in Physical Function at 4 Months | Measured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 4 Months |
|
|
|
| Secondary | Change From Baseline in Physical Function at 4 Months | Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise. These data are presented as the change from baseline values where higher values indicate better physical function (scoring range 0-12). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 4 Months |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 3 |
| 28 |
| EG001 | Usual Care Group | Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase. | 0 | 22 | 0 | 22 | 0 | 22 |
|
| Unrelated Medical Issue | Musculoskeletal and connective tissue disorders | Systematic Assessment | Spinal injury in a motor vehicle accident |
|
| Unrelated Medical Issue | Musculoskeletal and connective tissue disorders | Systematic Assessment | exacerbation of chronic knee arthritis pain |
|
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |