Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Cheryl Anderson, PhD, MPH, MS
Headshot of Cheryl Anderson
Cheryl Anderson

Description

Summary

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."

Details

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).

Keywords

Heart Failure, Heart Failure,Congestive, Heart Diseases, 15 Medically Tailored Meals (MTM) per week, 14 Medically Tailored Meals (MTM) per week

Eligibility

You can join if…

Open to people ages 18 years and up

  • Willingness to comply with all study procedures and availability for the duration of the study
  • Living in San Diego or the Bay Area of California
  • Reported congestive heart failure (CHF) diagnosis
  • Current diet can be improved
  • Willing to eat all meals provided by the study

You CAN'T join if...

  • Diagnosed with end-stage heart failure
  • Diagnosed with diabetes (type 1 or uncontrolled type 2)
  • Currently taking insulin and/or meglitinides medications
  • Hemoglobin A1c (HbA1c) results >8 %
  • Life expectancy of <1 year
  • Pregnancy or lactation
  • Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat study-provided meals, including foods that are prepared in a facility that works with the allergen
  • Current smoker or tobacco use within the past year
  • Planning to leave San Diego or the Bay Area during the course of the study
  • Unable to communicate reasonably well either orally or through written material in English
  • Those who, in the opinion of the investigators, cannot reliably complete the study protocol

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientist at UCSD

  • Cheryl Anderson, PhD, MPH, MS
    Cheryl A. M. Anderson is a Professor and Dean of the University of California San Diego Herbert Wertheim School of Public Health and Human Longevity Science. Dr. Anderson's research focuses on nutrition and chronic disease prevention in underserved populations using observational epidemiologic study designs, randomized clinical trials, and implementation science.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06540118
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated