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

Study Overview
=================
Brief 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).

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

Conditions
-----------------
PreDiabetes, Type2 Diabetes Mellitus, Hypertension, Overweight and Obesity

Intervention / Treatment
-----------------
* Behavioral: DASH diet
* Behavioral: Very low carbohydrate, ketogenic diet
* Behavioral: Extras


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of 25-50 Diagnosis pre-hypertension or hypertension (within the past 6 months) and current resting systolic blood pressure > 130 mmHg. Diagnosis of either prediabetes or type 2 diabetes, defined as: HbA1c of at least 5.7% or Two-hour glucose tolerance test >140 mg/dL Aged 21-70 years old Access to the internet and text messaging Ability to engage in light physical activity Sufficient control over their food intake to adhere to study diets Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 4-month trial Participation in the trial approved by primary care provider, along with agreement to work with the participant and our research team to manage medication changes Exclusion Criteria: Non-English speaking Current use of insulin, Dilantin, lithium, and warfarin Inability to complete baseline measurements Severe renal or hepatic insufficiency Cardiovascular dysfunction, including diagnosis of: Congestive heart failure Angina Arrhythmias Cardiomyopathy Valvular heart disease Uncontrolled psychiatric disorder Consumes >30 alcoholic drinks per week Currently undergoing chemotherapy Pregnant or planning to get pregnant in the next 12 months Breastfeeding or less than 6 months' post-partum Planned weight loss surgery or similar surgery performed previously Vegan or vegetarian Currently enrolled in a weight loss program or take weight loss supplements (that are not willing to be stopped before enrolling) Expecting to move out of the area within 12 months Any other medical condition that may make either diet dangerous as determined by the study medical team.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 full factorial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: DASH diet<br>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: DASH diet<br>* 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).<br>|
| Experimental: Experimental: very low carbohydrate, ketogenic diet<br>Participants will be taught to follow a very low-carbohydrate, ketogenic 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: Very low carbohydrate, ketogenic diet<br>* 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).<br>|
| Experimental: Experimental: DASH diet and extra support<br>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). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. | Behavioral: DASH diet<br>* 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).<br>Behavioral: Extras<br>* Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.<br>|
| Experimental: Experimental: very low carb, ketogenic diet and extra support<br>Participants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. | Behavioral: Very low carbohydrate, ketogenic diet<br>* 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).<br>Behavioral: Extras<br>* Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Measured with sphygmomanometer, assessed as change in blood pressure (systolic and diastolic blood pressure will both be measured, but systolic blood pressure is the main outcome) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Measured with HbA1c, assessed as change in HbA1c | 4 months | 
| Weight loss | Measured by body weight scale, assessed as change in percent body weight lost | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary intervention