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| ID | Type | Description | Link |
|---|---|---|---|
| RX003739-01A1 | Other Grant/Funding Number | Veteran Affairs Rehabilitation R&D Service |
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The majority of older Veterans do not meet the minimum healthy diet or physical activity recommendations, despite known benefits. Identifying novel ways to increase adherence to rehabilitation programs that improve dietary quality and physical activity may reduce the risk of disability in older Veterans. Peer-based interventions may be one method to facilitate lasting behavioral change since peers often share a common culture and knowledge about the problems that their community experiences. The investigators propose to develop and evaluate a novel peer-led diet and exercise intervention that targets older Veterans with multiple chronic health conditions. Successful development and pilot of this intervention will provide the preliminary data for a larger multisite trial focused on the use of peer-led interventions to improve long-term compliance to lifestyle interventions in older Veterans.
Over the next ten years the share of Veterans age 65+ years will increase to over 50% of the total Veteran population. The ability to safely maintain mobility with aging is critical. Older Veterans with multiple chronic health conditions are more likely to experience mobility decline and report reduced physical activity levels and poor dietary quality. While a multitude of interventions have attempted to address poor diet and physical inactivity in older adults; most have utilized resource-intensive professionally led diet OR exercise interventions, and few have focused on the unique needs of older Veterans. Peer support offers a potentially low-cost, easily scalable approach to encourage long-term dietary and physical activity change.
In this proposal the investigators seek to develop and pilot a 12-week peer-led lifestyle intervention that targets older Veterans with multiple chronic health conditions and dysmobility, in two diverse urban areas with a high percentage of underrepresented minority Veteran populations (Baltimore, MD and San Antonio, TX). The investigators will develop a theory-driven, peer-led nutrition and exercise intervention tailored for older Veterans with dysmobility. The investigators will also determine the feasibility and acceptability of the peer-led intervention as well as the estimated magnitude and potential impact on selected outcomes (i.e diet quality and mobility) in older Veterans with dysmobility and multiple chronic health conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer led diet and exercise intervention | Experimental | participation in two-times per week diet and exercise peer led interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Intervention | Other | Participants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiovascular Endurance | Cardiovascular endurance will be assessed with the distance covered during a six-minute walk test. The distance covered from baseline will be compared to post 12-week intervention. | 12-weeks |
| Change in Diet Quality as Measured by the HEI Score | Food records will be gathered and analyzed using the automated self-administered recall system (ASA24) to evaluate diet quality. Results from baseline will be compared to those after 12 weeks of intervention. The Healthy Eating Index (HEI) is a summary score describing dietary quality on a 0-100 scale; higher scores indicate better diet quality. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mobility as Measured by the 30 Second Chair Stand Test | The number of time and individuals can rise from a chair-without using their arms during a 30-second time period will be recorded and used as a measure of mobility. Results from baseline will be compared to those after 12-weeks of intervention. | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odessa R. Addison, PhD DPT | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35830251 | Derived | Robbins RN, Serra MC, Kilpela LS, Parker EA, Jiwani R, Addison O. Intervention in Older Urban-Dwelling Veterans With Dysmobility: Protocol for a Pilot Feasibility Clinical Trial. JMIR Res Protoc. 2022 Jul 13;11(7):e39192. doi: 10.2196/39192. |
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Both Peer Leaders and Participants were recruited and consented for this study. However, data was only collected for the 14 participants (who were studied), data was not collected for peer leaders.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Led Diet and Exercise Intervention - All Study Participants | participation in two-times per week diet and exercise peer led interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Both Peer Leaders and Participants were recruited and consented for this study. However, Baseline data was only collected for the 14 participants (who were studied). Of the 23 individuals who were enrolled and completed the protocol, 14 were the participants being studied and 9 were peer leaders (who were not studied). Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Led Diet and Exercise Intervention | participation in two-times per week diet and exercise peer led interventions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 in Cardiovascular Endurance | Cardiovascular endurance will be assessed with the distance covered during a six-minute walk test. The distance covered from baseline will be compared to post 12-week intervention. | Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants and do not include Peer Leaders | Posted | Mean | Standard Deviation | yards | 12-weeks |
|
|
Adverse events were collected during participant's entire duration of study participation, which was 12 weeks.
The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.
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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 | Peer Leader | Peer leaders trained to lead the interventions two times per week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Positive COVID test | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Odessa Addison | Baltimore VAMC | 410-605-7000 | 55393 | Odessa.Addison@va.gov |
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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 12, 2023 | Dec 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2024 | Jan 23, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Exercise Intervention | Other | Participants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks. |
|
| South Texas Health Care System, San Antonio, TX |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Participants |
|
|
|
| Primary | Change in Diet Quality as Measured by the HEI Score | Food records will be gathered and analyzed using the automated self-administered recall system (ASA24) to evaluate diet quality. Results from baseline will be compared to those after 12 weeks of intervention. The Healthy Eating Index (HEI) is a summary score describing dietary quality on a 0-100 scale; higher scores indicate better diet quality. | Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants and do not include Peer Leaders | Posted | Mean | Standard Deviation | score on a scale of 100 | 12-weeks |
|
|
|
|
| Secondary | Change in Mobility as Measured by the 30 Second Chair Stand Test | The number of time and individuals can rise from a chair-without using their arms during a 30-second time period will be recorded and used as a measure of mobility. Results from baseline will be compared to those after 12-weeks of intervention. | Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants and do not include Peer Leaders | Posted | Mean | Standard Deviation | stands | 12-weeks |
|
|
|
|
| 2 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | Peer Led Diet and Exercise Intervention | participation in two-times per week diet and exercise peer led interventions. | 2 | 14 | 2 | 14 | 0 | 14 |
| Vertigo | Cardiac disorders | Non-systematic Assessment | Hospitalized for vertigo, diagnosed with CAD and 70% occlusion to an artery. |
|
| SOB and Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
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