Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure

Study Overview
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Brief Summary
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This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.

Detailed Description
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This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).

Official Title
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Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure

Conditions
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Heart Failure, Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Other: DASH Diet
* Other: Usual diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will have an education level of less than college as a surrogate marker of LSES. Exclusion Criteria: Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire) poorly controlled diabetes mellitus ( HBA 1c >9%) or uncontrolled hypertension ( SBP>180, DBP>110) cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients) body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DASH diet group<br>Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day. | Other: DASH Diet<br>* 12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). Participants will prepare their own breakfast from a menu.The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.<br>* Other names: Dietary Approaches to Stop Hypertension;|
| Active Comparator: Attention Control Group<br>Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study. | Other: Usual diet<br>* 12 weeks usual diet <2300 mg Na/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of enrolled participants per week |  | Up to week 12 | 
| Proportion of participants that adhere to the to intervention |  | Up to week 12 | 
| Number participants that were retained in the trial |  | Up to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that adhere to the diet |  | Up to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DASH Diet, Low socioeconomic status, HFPEF