Mobile Health Intervention to Support Healthful Diet

Not Applicable

Completed

• Conditions: Frailty
• Interventions: Behavioral: Mobile app

• Registration Number: NCT05236712
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-11
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Results First Submitted: 2023-11-22
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Results First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Age 65+

Mild to moderate frailty

Suboptimal diet

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile health	Mobile app	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline HOMA-IR Score at 3 Months	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.
Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months	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)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Negative Outcome Expectations Score at 3 Months	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
Change From Baseline Positive Outcome Expectations Score at 3 Months	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
Change From Baseline Self-Efficacy Score at 3 Months	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
Change From Baseline Social Support Score at 3 Months	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
Change From Baseline Mediterranean Diet Knowledge Score at 3 Months	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
Change From Baseline Physical Performance Measure at 3 Months	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
Change From Baseline BMI at 3 Months	baseline, 3 month	BMI in units
Change From Baseline Self-regulation Score at 3 Months	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

Trial Locations

Locations (1)

Univeristy of Washington; 🇺🇸 Seattle, Washington, United States