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The Ready-to-Eat Meals for Cardiovascular Health Study (REACH)

Primary Purpose

Diet, Hypertension, Cardiovascular Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ready-to-eat meals
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diet focused on measuring DASH, Dietary Approaches to Stop Hypertension, Meals, High Blood Pressure, Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female
  • 18 years old or older
  • BMI 18.5-40.0 kg/m2
  • Daily access to working internet, microwave, refrigerator, and freezer
  • English fluency

Exclusion Criteria:

  • Regular use of drugs that affect BP, including weight loss medications
  • Diagnosed hypertension OR systolic BP >130 and/or diastolic BP >80
  • Diagnosis of any hypotensive disorders OR systolic BP <100 and/or diastolic BP<65
  • Dietary restrictions, including allergy/intolerances
  • Presence or history of diabetes
  • Previous cardiac event, congestive heart failure, or angina
  • Weight loss or gain>15lb in previous 3 months
  • Following a diet to increase or decrease body weight
  • Cancer diagnosis or treatment in past 2 years
  • ≥14 alcoholic drinks/week for men; ≥ 7 alcoholic drinks/week for women
  • Use of nicotine, marijuana, or illicit drugs
  • Pregnancy, planned pregnancy, or breastfeeding
  • Inability to comprehend the nature of the study or instructions
  • No access to the internet
  • Planning to leave the Spokane area during the study
  • Not fluent in the English language

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Ready-to-eat meals

    Arm Description

    Pre-Post

    Outcomes

    Primary Outcome Measures

    Blood pressure
    To determine dietary patterns on blood pressure using an omron blood pressure monitor.

    Secondary Outcome Measures

    Body weight (kg)
    To determine dietary patterns on body weight (kg) using a Angel USA 400 Pound Physician Digital Scale.

    Full Information

    First Posted
    July 15, 2022
    Last Updated
    July 20, 2022
    Sponsor
    Washington State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05472454
    Brief Title
    The Ready-to-Eat Meals for Cardiovascular Health Study
    Acronym
    REACH
    Official Title
    The Ready-to-EAt Meals for Cardiovascular Health (REACH) Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed project explores the acceptability and health benefits of ready-to-eat (RTE) meals based on the Dietary Approaches to Stop Hypertension (DASH) eating plan. The researchers have developed 14 recipes following the DASH eating plan, which is recommended for the prevention of cardiovascular disease (CVD). The prepackaged meals will be processed using Washington State University (WSU) microwave technologies to ensure food safety. In this pilot study, a sample of 30 participants will be recruited by to study the impact of the DASH meals on blood pressure. All meals will be provided to participants, who will consume the meals daily over a period of 4 weeks. Daily and weekly monitoring of participants (blood pressure and weight) will allow us to gain a scientific understanding on the preventive power of healthy diets in lowering blood pressure and reducing CVD risk.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diet, Hypertension, Cardiovascular Diseases, Blood Pressure
    Keywords
    DASH, Dietary Approaches to Stop Hypertension, Meals, High Blood Pressure, Hypertension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pre-post design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ready-to-eat meals
    Arm Type
    Other
    Arm Description
    Pre-Post
    Intervention Type
    Other
    Intervention Name(s)
    Ready-to-eat meals
    Intervention Description
    Participant group to consume ready-to-eat meals in accordance with the DASH diet for a period of 4 weeks.
    Primary Outcome Measure Information:
    Title
    Blood pressure
    Description
    To determine dietary patterns on blood pressure using an omron blood pressure monitor.
    Time Frame
    through study completion, measured weekly for 5 weeks
    Secondary Outcome Measure Information:
    Title
    Body weight (kg)
    Description
    To determine dietary patterns on body weight (kg) using a Angel USA 400 Pound Physician Digital Scale.
    Time Frame
    through study completion, measured weekly for 5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or female 18 years old or older BMI 18.5-40.0 kg/m2 Daily access to working internet, microwave, refrigerator, and freezer English fluency Exclusion Criteria: Regular use of drugs that affect BP, including weight loss medications Diagnosed hypertension OR systolic BP >130 and/or diastolic BP >80 Diagnosis of any hypotensive disorders OR systolic BP <100 and/or diastolic BP<65 Dietary restrictions, including allergy/intolerances Presence or history of diabetes Previous cardiac event, congestive heart failure, or angina Weight loss or gain>15lb in previous 3 months Following a diet to increase or decrease body weight Cancer diagnosis or treatment in past 2 years ≥14 alcoholic drinks/week for men; ≥ 7 alcoholic drinks/week for women Use of nicotine, marijuana, or illicit drugs Pregnancy, planned pregnancy, or breastfeeding Inability to comprehend the nature of the study or instructions No access to the internet Planning to leave the Spokane area during the study Not fluent in the English language
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Gisselman, MS
    Phone
    509-368-6957
    Email
    food.lab@wsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martine Perrigue, PhD, RDN, CD
    Phone
    509-368-6911
    Email
    martine.perrigue@wsu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pablo Monsivais, PhD, MPH
    Organizational Affiliation
    Washington State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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