NCT03729479

The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type2 Diabetes Mellitus
• Hypertension
• PreDiabetes
• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	DASH diet	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).
BEHAVIORAL	Very low carbohydrate, ketogenic diet	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).
BEHAVIORAL	Extras	Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-08-09
• Completion: 2020-08-09
• First posted: 2018-11-02
• Last updated: 2020-09-29

Locations

1 site across 1 country: United States