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

Phase 1

Completed

• Conditions: Overweight and Obesity; Type2 Diabetes Mellitus; Hypertension; PreDiabetes
• Interventions: Behavioral: Very low carbohydrate, ketogenic diet; Behavioral: DASH diet; Behavioral: Extras

• Registration Number: NCT03729479
• Lead Sponsor: University of Michigan

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).

Study Timeline

• Study First Submitted: 2018-10-31
• Study Start: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Primary Completion: 2020-08-09
• Study Completion: 2020-08-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. BMI of 25-50

2. Diagnosis pre-hypertension or hypertension (within the past 6 months) and current resting systolic blood pressure > 130 mmHg.

3. Diagnosis of either prediabetes or type 2 diabetes, defined as:

   1. HbA1c of at least 5.7% or
   2. Two-hour glucose tolerance test >140 mg/dL

4. Aged 21-70 years old

5. Access to the internet and text messaging

6. Ability to engage in light physical activity

7. Sufficient control over their food intake to adhere to study diets

8. Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 4-month trial

9. 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

Read More

Exclusion Criteria

1. Non-English speaking

2. Current use of insulin, Dilantin, lithium, and warfarin

3. Inability to complete baseline measurements

4. Severe renal or hepatic insufficiency

5. Cardiovascular dysfunction, including diagnosis of:

   1. Congestive heart failure
   2. Angina
   3. Arrhythmias
   4. Cardiomyopathy
   5. Valvular heart disease

6. Uncontrolled psychiatric disorder

7. Consumes >30 alcoholic drinks per week

8. Currently undergoing chemotherapy

9. Pregnant or planning to get pregnant in the next 12 months

10. Breastfeeding or less than 6 months' post-partum

11. Planned weight loss surgery or similar surgery performed previously

12. Vegan or vegetarian

13. Currently enrolled in a weight loss program or take weight loss supplements (that are not willing to be stopped before enrolling)

14. Expecting to move out of the area within 12 months

15. Any other medical condition that may make either diet dangerous as determined by the study medical team.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental: very low carb, ketogenic diet and extra support	Very low carbohydrate, ketogenic diet	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.
Experimental: very low carb, ketogenic diet and extra support	Extras	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.
Experimental: DASH diet and extra support	Extras	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.
Experimental: DASH diet	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).
Experimental: very low carbohydrate, ketogenic diet	Very low carbohydrate, ketogenic diet	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).
Experimental: DASH diet and extra support	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). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	4 months	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)

Secondary Outcome Measures

Name	Time	Method
Weight loss	4 months	Measured by body weight scale, assessed as change in percent body weight lost
Glycemic control	4 months	Measured with HbA1c, assessed as change in HbA1c

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States