Frailty
Conditions
Brief summary
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.
Interventions
BEHAVIORALMobile 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.
Sponsors
National Institute on Aging (NIA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 65+ Mild to moderate frailty Suboptimal diet \-
Exclusion criteria
1. Dependence in activities of daily living 2. Memory Impairment 3. Hearing or visual impairment 4. Unusual dietary restrictions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months | baseline, 3 month | Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence) |
| Change From Baseline HOMA-IR Score at 3 Months | baseline, 3 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Negative Outcome Expectations Score at 3 Months | baseline, 3 month | 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 |
| Change From Baseline Self-regulation Score at 3 Months | baseline, 3 month | 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 |
| Change From Baseline Self-Efficacy Score at 3 Months | baseline, 3 month | Visual analog scale (VAS), 6 items using a 10-point scale. Higher values more self-efficacy. The total score ranges from O to 60 |
| Change From Baseline Mediterranean Diet Knowledge Score at 3 Months | baseline, 3 month | 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 |
| Change From Baseline Physical Performance Measure at 3 Months | baseline, 3 month | 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 |
| Change From Baseline BMI at 3 Months | baseline, 3 month | BMI in units |
| Change From Baseline Social Support Score at 3 Months | baseline, 3 month | 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 |
| Change From Baseline Positive Outcome Expectations Score at 3 Months | baseline, 3 month | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Usual Care Participants will receive information on public online resources | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Usual Care | Total | Mobile Health |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 15 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 70.0 years STANDARD_DEVIATION 3.9 | 71.27 years STANDARD_DEVIATION 4.43 | 72.4 years STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 7 participants | 15 participants | 8 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
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.
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline HOMA-IR Score at 3 Months | -0.18 score on a scale | Standard Deviation 0.72 |
| Usual Care | Change From Baseline HOMA-IR Score at 3 Months | 0.1 score on a scale | Standard Deviation 0.74 |
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)
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months | 2.63 score on a scale | Standard Deviation 2 |
| Usual Care | Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months | -0.29 score on a scale | Standard Deviation 1.38 |
Secondary
Change From Baseline BMI at 3 Months
BMI in units
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline BMI at 3 Months | -0.83 Kg/m^2 | Standard Deviation 0.95 |
| Usual Care | Change From Baseline BMI at 3 Months | -0.16 Kg/m^2 | Standard Deviation 0.65 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Mediterranean Diet Knowledge Score at 3 Months | 2.0 score on a scale | Standard Deviation 2.33 |
| Usual Care | Change From Baseline Mediterranean Diet Knowledge Score at 3 Months | -1.14 score on a scale | Standard Deviation 1.95 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Negative Outcome Expectations Score at 3 Months | -3.25 score on a scale | Standard Error 3.62 |
| Usual Care | Change From Baseline Negative Outcome Expectations Score at 3 Months | -0.43 score on a scale | Standard Error 1.9 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Physical Performance Measure at 3 Months | 1.5 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change From Baseline Physical Performance Measure at 3 Months | 0.14 score on a scale | Standard Deviation 0.9 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Positive Outcome Expectations Score at 3 Months | 1.5 score on a scale | Standard Deviation 5.26 |
| Usual Care | Change From Baseline Positive Outcome Expectations Score at 3 Months | 1.0 score on a scale | Standard Deviation 3.74 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Self-Efficacy Score at 3 Months | 1.75 score on a scale | Standard Deviation 10.59 |
| Usual Care | Change From Baseline Self-Efficacy Score at 3 Months | -2.0 score on a scale | Standard Deviation 10.21 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Self-regulation Score at 3 Months | -0.13 score on a scale | Standard Error 1.25 |
| Usual Care | Change From Baseline Self-regulation Score at 3 Months | -1.86 score on a scale | Standard Error 3.13 |
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
Time frame: baseline, 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health | Change From Baseline Social Support Score at 3 Months | 1.5 score on a scale | Standard Deviation 1.41 |
| Usual Care | Change From Baseline Social Support Score at 3 Months | -0.14 score on a scale | Standard Deviation 2.19 |