Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT03170375
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Performance of WHEELS-I in promoting DASH/SRD adoption — BEHAVIORAL
    All participants will receive motivational interviewing (MI) based counseling. Participants in the MI + WHEELS-I arm will also receive the WHEELS-I electronically-delivered tailored messaging.

Study Details

Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.

Key Dates

Start date
Jan 2, 2019
Status verified
Aug 2025
Primary completion
Mar 31, 2024
Completion
Jan 23, 2025

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Motivational Interviewing + WHEELS-I
    In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I). Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.
  • Active Comparator: Motivational Interviewing
    Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan. Randomization will occur after phase 1 of the study which includes 2 weeks of an ad lib diet followed by 2 weeks of prepared pre-packaged DASH/SRD meals.

Primary Outcome Measure

Carotid-femoral Pulse Wave Velocity [ Time Frame: Phase 1 of study, change between week 2 and week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303-

Find similar trials in Ann Arbor, MI

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VA Ann Arbor Healthcare System, Ann Arbor, MI· Ann Arbor, MI

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