NCT05236712

Mobile Health Intervention to Support Healthful Diet

Completed NA Results posted Last updated 9 January 2024

What this trial tests

NA trial testing Mobile app in Frailty in 15 participants. Completed in 28 February 2023.

Timeline

1 January 2022

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	15
Start date	1 January 2022
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Mobile app

Conditions studied

• Frailty — all drugs for Frailty →

Sponsor

University of Washington

Who can join

65 and older, any sex, with Frailty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months Primary · 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)

Group	Value	95% CI
Mobile Health	2.63	± 2.0
Usual Care	-0.29	± 1.38

Change From Baseline HOMA-IR Score at 3 Months Primary · 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.

Group	Value	95% CI
Mobile Health	-0.18	± 0.72
Usual Care	0.1	± 0.74

Change From Baseline Mediterranean Diet Knowledge Score at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	2.0	± 2.33
Usual Care	-1.14	± 1.95

Change From Baseline Positive Outcome Expectations Score at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	1.5	± 5.26
Usual Care	1.0	± 3.74

Change From Baseline Negative Outcome Expectations Score at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	-3.25	± 3.62
Usual Care	-0.43	± 1.9

Change From Baseline Self-regulation Score at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	-0.13	± 1.25
Usual Care	-1.86	± 3.13

Change From Baseline Self-Efficacy Score at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	1.75	± 10.59
Usual Care	-2.0	± 10.21

Change From Baseline Social Support Score at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	1.5	± 1.41
Usual Care	-0.14	± 2.19

Change From Baseline Physical Performance Measure at 3 Months Secondary · 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

Group	Value	95% CI
Mobile Health	1.5	± 1.2
Usual Care	0.14	± 0.9

Change From Baseline BMI at 3 Months Secondary · baseline, 3 month

BMI in units

Group	Value	95% CI
Mobile Health	-0.83	± 0.95
Usual Care	-0.16	± 0.65

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Mobile Intervention Designed Specifically for Older Adults With Frailty to Support Healthy Eating: Pilot Randomized Controlled Trial.
   Su Y, Wu KC, Chien SY, Naik A, et al · · 2023 · cited 8× · PMID 37966877 · DOI 10.2196/50870