Mobile Health Intervention to Support Healthful Diet
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile app
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty
Eligibility Criteria
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
Sites / Locations
- Univeristy of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile health
Usual care
Arm Description
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
Participants will receive information on public online resources
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
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
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
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
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
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
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
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
Change from Baseline Weight at 3 months
Weight measured in kg
Full Information
NCT ID
NCT05236712
First Posted
January 19, 2022
Last Updated
May 8, 2023
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05236712
Brief Title
Mobile Health Intervention to Support Healthful Diet
Official Title
Pilot Clinical Trial for a Mobile Health Intervention to Support Healthful Dietary Choices in Older Person
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile health
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants will receive information on public online resources
Intervention Type
Behavioral
Intervention Name(s)
Mobile app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Mediterranean Diet (MED) Adherence Score at 3 months
Description
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
Title
Change from Baseline Insulin Resistance Score at 3 months
Description
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
Time Frame
baseline, 3 month
Secondary Outcome Measure Information:
Title
Change from Baseline Mediterranean Diet Knowledge Score at 3 months
Description
MedD knowledge will be assessed using the Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire. Scores range from 0 to 30. Higher score higher knowledge
Time Frame
baseline, 3 month
Title
Change from Baseline Positive Outcome Expectations Score at 3 months
Description
Questionnaire, 7 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more positive outcome expectations
Time Frame
baseline, 3 month
Title
Change from Baseline Negative Outcome Expectations Score at 3 months
Description
Questionnaire, 6 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more negative outcome expectations
Time Frame
baseline, 3 month
Title
Change from Baseline Self-regulation Score at 3 months
Description
Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more self-regulation
Time Frame
baseline, 3 month
Title
Change from Baseline Self-Efficacy Score at 3 months
Description
Visual analog scale (VAS), 6 items using a 100-point scale. Higher values more self-efficacy
Time Frame
baseline, 3 month
Title
Change from Baseline Social Support score at 3 months
Description
Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more social support
Time Frame
baseline, 3 month
Title
Change from Baseline Physical Performance Measure at 3 months
Description
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
Title
Change from Baseline Weight at 3 months
Description
Weight measured in kg
Time Frame
baseline, 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg Zaslavsky, PhD, MHA, RN
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mobile Health Intervention to Support Healthful Diet
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