REACH: The Ready-to-Eat Meals for Cardiovascular Health Study

Sponsor

Washington State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05472454

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diet Hypertension Cardiovascular Diseases Blood Pressure	Other: Ready-to-eat meals	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-post designPre-post design

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Ready-to-eat meals Pre-Post	Other: Ready-to-eat meals Participant group to consume ready-to-eat meals in accordance with the DASH diet for a period of 4 weeks.

Arm

Intervention/Treatment

Other: Ready-to-eat meals

Pre-Post

Other: Ready-to-eat meals

Participant group to consume ready-to-eat meals in accordance with the DASH diet for a period of 4 weeks.

Outcome Measures

Primary Outcome Measures

Blood pressure [through study completion, measured weekly for 5 weeks]
To determine dietary patterns on blood pressure using an omron blood pressure monitor.

Secondary Outcome Measures

Body weight (kg) [through study completion, measured weekly for 5 weeks]
To determine dietary patterns on body weight (kg) using a Angel USA 400 Pound Physician Digital Scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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