Mobile Health Intervention to Support Healthful Diet

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Clinical Trial for a Mobile Health Intervention to Support Healthful Dietary Choices in Older Person

Conditions
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Frailty

Intervention / Treatment
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* Behavioral: Mobile app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65+ Mild to moderate frailty Suboptimal diet - Exclusion Criteria: Dependence in activities of daily living Memory Impairment Hearing or visual impairment Unusual dietary restrictions

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile health<br>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 | Behavioral: Mobile app<br>* 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.<br>|
| No Intervention: Usual care<br>Participants will receive information on public online resources | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Insulin Resistance Score at 3 months | Insulin resistance scores, homeostatic model (HOMA-IR) will be calculated with the following formula: fasting plasma glucose (in mmol/L) X fasting plasma insulin (in lU/mL) divided by 22.5 | baseline, 3 month | 

Secondary Outcome Measures

| Outcome Measure | 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. Scores range from 0 to 30. Higher score higher knowledge | baseline, 3 month | 
| 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 | 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 | 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 | baseline, 3 month | 
| Change from Baseline Self-Efficacy Score at 3 months | Visual analog scale (VAS), 6 items using a 100-point scale. Higher values more self-efficacy | 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 | 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 Weight at 3 months | Weight measured in kg | baseline, 3 month |