Mobile Health Intervention to Support Healthful Diet

University of Washington

Status: Completed

Conditions: Frailty

Treatments: Behavioral: Mobile app

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05236712

K23AG059912-01A1 (U.S. NIH Grant/Contract)

STUDY00012842

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age 65+

Mild to moderate frailty

Suboptimal diet

Exclusion criteria

1. Dependence in activities of daily living
2. Memory Impairment
3. Hearing or visual impairment
4. Unusual dietary restrictions

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Mobile health

Experimental group

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

Treatment:

Behavioral: Mobile app

Usual care

No Intervention group

Description:

Participants will receive information on public online resources