Mobile Health Intervention to Support Healthful Diet

NCT05236712 | Completed Results

• 2 other identifiers: STUDY00012842K23AG059912-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (2)

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

  Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence)

  baseline, 3 month

• Change From Baseline HOMA-IR Score at 3 Months

  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.

  baseline, 3 month

Secondary Outcomes (8)

• Change From Baseline Mediterranean Diet Knowledge Score at 3 Months

  baseline, 3 month

• Change From Baseline Positive Outcome Expectations Score at 3 Months

  baseline, 3 month

• Change From Baseline Negative Outcome Expectations Score at 3 Months

  baseline, 3 month

• Change From Baseline Self-regulation Score at 3 Months

  baseline, 3 month

• Change From Baseline Self-Efficacy Score at 3 Months

  baseline, 3 month

Study Arms (2)

Mobile health

EXPERIMENTAL

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

Behavioral: Mobile app

Usual care

NO INTERVENTION

Participants will receive information on public online resources

Interventions

Mobile app 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.

Mobile health

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65+
• Mild to moderate frailty
• Suboptimal diet

You may not qualify if:

• Dependence in activities of daily living
• Memory Impairment
• Hearing or visual impairment
• Unusual dietary restrictions

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Univeristy of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 37966877 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Oleg Zaslavsky
• Organization: Univcersity of Washington

ozasl@uw.edu

2068493301

Study Officials

• Oleg Zaslavsky, PhD, MHA, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Biobehavioral Nursing & Health Informatics

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 11, 2022
• Study Start: January 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Locations

US (1)