Hypertension Clinical Trial
Official title:
The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
This study will compare the low-sodium/low-fat DASH (Dietary Approaches to Stop Hypertension) diet with a very low-carbohydrate diet, helping us to better understand how two different dietary approaches may help participants control their blood pressure, lose weight, and reduce their blood glucose.
Adults with overweight or obesity, hypertension, and prediabetes or type 2 diabetes are at a
high risk of adverse health outcomes including stroke, renal disease, myocardial infarction,
and premature death. Evidence suggests that the first-line treatment for adults with this
triple burden should be a comprehensive diet and lifestyle intervention.
However, experts disagree about which diet should be recommended. The Dietary Approaches to
Stop Hypertension (DASH) diet, a lower fat diet, is the de facto diet for adults with
hypertension. A very low-carbohydrate (VLC) diet, a higher fat diet, is becoming the de facto
diet for weight and glycemic control. In addition, a VLC diet may reduce blood pressure
through weight loss and its impact on insulin (which alters renal sodium transport and leads
to diuresis). Given that these two diets, DASH and very low-carbohydrate, are extremely
promising options for this population, and the fact that they have never been compared in
this population or any other, this comparison is strongly warranted.
The investigators propose to use an interprofessional team (with expertise in nursing,
psychology, medicine, policy, nutrition, pharmacy, and behavioral interventions) to conduct a
comparative effectiveness trial of two different diets for adults with this triple burden.
The HERO Study (Hypertension, Diabetes, and Obesity Education Research Online) will compare
the health effects of the DASH and VLC diets.
The investigators propose one aim:
Test the feasibility, acceptability, and preliminary comparative efficacy of the
interventions. The investigators will randomize 140 adults with this triple burden to the
DASH or VLC versions of the 4-month intervention. Outcome measures include intervention
feasibility (recruitment and retention); acceptability (satisfaction with the intervention);
and preliminary comparative efficacy as determined by changes in our primary outcome
(systolic blood pressure), as well as exploratory secondary outcomes (weight, glycemic
control).
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