Mobile Health Intervention to Support Healthful Diet

NCT ID: NCT05236712

Last Updated: 2024-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mobile health

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

Group Type EXPERIMENTAL

Mobile app

Intervention Type BEHAVIORAL

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.

Usual care

Participants will receive information on public online resources

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile app

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Oleg Zaslavsky

Associate Professor: Biobehavioral Nursing & Health Informatics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oleg Zaslavsky, PhD, MHA, RN

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Univeristy of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Su Y, Wu KC, Chien SY, Naik A, Zaslavsky O. A Mobile Intervention Designed Specifically for Older Adults With Frailty to Support Healthy Eating: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Nov 15;7:e50870. doi: 10.2196/50870.

Reference Type DERIVED
PMID: 37966877 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K23AG059912-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00012842

Identifier Type: -

Identifier Source: org_study_id

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