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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG059912-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This will be a pilot clinical trial to evaluate preliminary efficacy of a newly designed mobile intervention designed to support healthy eating in old people. The main scientific premise of this project is that mobile approaches are feasible for behavioral and metabolic improvements in the population of people 65+ with mild-to-moderate frailty. Specific Aim of this project is to describe feasibility, acceptability and initial efficacy of the newly designed mobile intervention in a pilot RCT. The pilot RCT, comparing usual care to usual care plus mobile intervention, will provide data on the sensitivity of outcome measures and estimated effect size to inform a larger RCT. Primary outcomes for the pilot RCT will include change in adherence to Mediterranean diet (MedD) score, change in insulin sensitivity measures, feasibility and acceptability. Secondary outcomes include MedD knowledge, self-efficacy, outcome expectation, self-regulation, social support, platform use and anthropometric and functional measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile health | Experimental | Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week |
|
| Usual care | No Intervention | Participants will receive information on public online resources |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile app | Behavioral | The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months | Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence) | baseline, 3 month |
| Change From Baseline HOMA-IR Score at 3 Months | Insulin resistance scores, homeostatic model (HOMA-IR) was calculated with the following formula: fasting plasma glucose (in mmol/L) X fasting plasma insulin (in lU/mL) divided by 22.5. Higher score indicates worse insulin resistance. Typically, a HOMA-IR value of less than 1 is considered normal, indicating low insulin resistance. | baseline, 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Mediterranean Diet Knowledge Score at 3 Months | MedD knowledge will be assessed using the Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire. The total scores range from 0 to 30. Higher score higher knowledge | baseline, 3 month |
| Change From Baseline Positive Outcome Expectations Score at 3 Months |
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Inclusion Criteria:
Age 65+
Mild to moderate frailty
Suboptimal diet
-
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oleg Zaslavsky, PhD, MHA, RN | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37966877 | Derived | Su Y, Wu KC, Chien SY, Naik A, Zaslavsky O. A Mobile Intervention Designed Specifically for Older Adults With Frailty to Support Healthy Eating: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Nov 15;7:e50870. doi: 10.2196/50870. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Health | Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts. |
| FG001 | Usual Care | Participants will receive information on public online resources |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Health | Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts. |
| 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 From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months | Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence) | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
three months
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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 | Mobile Health | Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oleg Zaslavsky | Univcersity of Washington | 2068493301 | ozasl@uw.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, 2023 | Dec 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Questionnaire, 7 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more positive outcome expectations. The total scale ranges from 7 to 35 |
| baseline, 3 month |
| Change From Baseline Negative Outcome Expectations Score at 3 Months | Questionnaire, 6 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more negative outcome expectations. The total score ranges from 30 to 6 | baseline, 3 month |
| Change From Baseline Self-regulation Score at 3 Months | Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more self-regulation. The total scale ranges from 10 to 2 | baseline, 3 month |
| Change From Baseline Self-Efficacy Score at 3 Months | Visual analog scale (VAS), 6 items using a 10-point scale. Higher values more self-efficacy. The total score ranges from O to 60 | baseline, 3 month |
| Change From Baseline Social Support Score at 3 Months | Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more social support. The total score ranges from 10 to 2 | baseline, 3 month |
| Change From Baseline Physical Performance Measure at 3 Months | Short Physical Performance Battery (SPPB) is a composite measure assessing walking speed, standing balance, and sit-to-stand performance. The three tests are summed to give a total score, with a maximum of 12 and minimum of 0. Higher score higher function | baseline, 3 month |
| Change From Baseline BMI at 3 Months | BMI in units | baseline, 3 month |
| BG001 | Usual Care | Participants will receive information on public online resources |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Care | Participants will receive information on public online resources |
|
|
| Primary | Change From Baseline HOMA-IR Score at 3 Months | Insulin resistance scores, homeostatic model (HOMA-IR) was calculated with the following formula: fasting plasma glucose (in mmol/L) X fasting plasma insulin (in lU/mL) divided by 22.5. Higher score indicates worse insulin resistance. Typically, a HOMA-IR value of less than 1 is considered normal, indicating low insulin resistance. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Mediterranean Diet Knowledge Score at 3 Months | MedD knowledge will be assessed using the Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire. The total scores range from 0 to 30. Higher score higher knowledge | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Positive Outcome Expectations Score at 3 Months | Questionnaire, 7 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more positive outcome expectations. The total scale ranges from 7 to 35 | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Negative Outcome Expectations Score at 3 Months | Questionnaire, 6 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more negative outcome expectations. The total score ranges from 30 to 6 | Posted | Mean | Standard Error | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Self-regulation Score at 3 Months | Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more self-regulation. The total scale ranges from 10 to 2 | Posted | Mean | Standard Error | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Self-Efficacy Score at 3 Months | Visual analog scale (VAS), 6 items using a 10-point scale. Higher values more self-efficacy. The total score ranges from O to 60 | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Social Support Score at 3 Months | Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more social support. The total score ranges from 10 to 2 | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline Physical Performance Measure at 3 Months | Short Physical Performance Battery (SPPB) is a composite measure assessing walking speed, standing balance, and sit-to-stand performance. The three tests are summed to give a total score, with a maximum of 12 and minimum of 0. Higher score higher function | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 month |
|
|
|
| Secondary | Change From Baseline BMI at 3 Months | BMI in units | Posted | Mean | Standard Deviation | Kg/m^2 | baseline, 3 month |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Usual Care | Participants will receive information on public online resources | 0 | 7 | 0 | 7 | 0 | 7 |
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