Pilot Clinical Trial for a Mobile Health Intervention to Support Healthful Dietary Choices in Older Person
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- University of Washington
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change From Baseline HOMA-IR Score at 3 Months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Oleg Zaslavsky
Associate Professor: Biobehavioral Nursing & Health Informatics
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Mild to moderate frailty
- •Suboptimal diet
Exclusion Criteria
- •Dependence in activities of daily living
- •Memory Impairment
- •Hearing or visual impairment
- •Unusual dietary restrictions
Outcomes
Primary Outcomes
Change From Baseline HOMA-IR Score at 3 Months
Time Frame: 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.
Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months
Time Frame: 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)
Secondary Outcomes
- Change From Baseline Negative Outcome Expectations Score at 3 Months(baseline, 3 month)
- Change From Baseline Positive Outcome Expectations Score at 3 Months(baseline, 3 month)
- Change From Baseline Self-Efficacy Score at 3 Months(baseline, 3 month)
- Change From Baseline Social Support Score at 3 Months(baseline, 3 month)
- Change From Baseline Mediterranean Diet Knowledge Score at 3 Months(baseline, 3 month)
- Change From Baseline Physical Performance Measure at 3 Months(baseline, 3 month)
- Change From Baseline BMI at 3 Months(baseline, 3 month)
- Change From Baseline Self-regulation Score at 3 Months(baseline, 3 month)