The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Condition: Type2 Diabetes Mellitus; Hypertension; PreDiabetes; Overweight and Obesity
MeSH terms: Hypertension; Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): DASH diet; Very low carbohydrate, ketogenic diet; Extras
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted).; Participants will be taught to follow a very low-carbohydrate diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted).; Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 full factorial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dietary intervention