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OpenTrials
Completed

NCT Number: NCT05236712

Mobile Health Intervention to Support Healthful Diet

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 65+

Mild to moderate frailty

Suboptimal diet

-

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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)

  2. Change From Baseline HOMA-IR Score at 3 Months

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline Mediterranean Diet Knowledge Score at 3 Months

    Time frame: 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

  2. Change From Baseline Positive Outcome Expectations Score at 3 Months

    Time frame: 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

  3. Change From Baseline Negative Outcome Expectations Score at 3 Months

    Time frame: 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

  4. Change From Baseline Self-regulation Score at 3 Months

    Time frame: 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

  5. Change From Baseline Self-Efficacy Score at 3 Months

    Time frame: 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

  6. Change From Baseline Social Support Score at 3 Months

    Time frame: 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

  7. Change From Baseline Physical Performance Measure at 3 Months

    Time frame: 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

  8. Change From Baseline BMI at 3 Months

    Time frame: baseline, 3 month

    BMI in units

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Pilot Clinical Trial for a Mobile Health Intervention to Support Healthful Dietary Choices in Older Person

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2022
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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