N/A
Completed N=15
Mobile Health Intervention to Support Healthful Diet
Source: ClinicalTrials.gov NCT05236712 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months — 2.63; -0.29 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months |
2.63; -0.29 | — |
| PRIMARY Change From Baseline HOMA-IR Score at 3 Months |
-0.18; 0.1 | — |
| SECONDARY Change From Baseline Mediterranean Diet Knowledge Score at 3 Months |
2.0; -1.14 | — |
| SECONDARY Change From Baseline Positive Outcome Expectations Score at 3 Months |
1.5; 1.0 | — |
| SECONDARY Change From Baseline Negative Outcome Expectations Score at 3 Months |
-3.25; -0.43 | — |
| SECONDARY Change From Baseline Self-regulation Score at 3 Months |
-0.13; -1.86 | — |
| SECONDARY Change From Baseline Self-Efficacy Score at 3 Months |
1.75; -2.0 | — |
| SECONDARY Change From Baseline Social Support Score at 3 Months |
1.5; -0.14 | — |
| SECONDARY Change From Baseline Physical Performance Measure at 3 Months |
1.5; 0.14 | — |
| SECONDARY Change From Baseline BMI at 3 Months |
-0.83; -0.16 | — |
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
Data sourced from ClinicalTrials.gov (NCT05236712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.