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

Primary Purpose

Type2 Diabetes Mellitus, Hypertension, PreDiabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DASH diet
Very low carbohydrate, ketogenic diet
Extras
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring dietary intervention

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Experimental: DASH diet

Experimental: very low carbohydrate, ketogenic diet

Experimental: DASH diet and extra support

Experimental: very low carb, ketogenic diet and extra support

Arm Description

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, 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).

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Glycemic control
Measured with HbA1c, assessed as change in HbA1c
Weight loss
Measured by body weight scale, assessed as change in percent body weight lost

Full Information

First Posted
October 31, 2018
Last Updated
September 28, 2020
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03729479
Brief Title
The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Official Title
The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 9, 2020 (Actual)
Study Completion Date
August 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus, Hypertension, PreDiabetes, Overweight and Obesity
Keywords
dietary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Model Description
2x2 full factorial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: DASH diet
Arm Type
Experimental
Arm Description
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).
Arm Title
Experimental: very low carbohydrate, ketogenic diet
Arm Type
Experimental
Arm Description
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).
Arm Title
Experimental: DASH diet and extra support
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental: very low carb, ketogenic diet and extra support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DASH diet
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Very low carbohydrate, ketogenic diet
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Extras
Intervention Description
Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
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)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Measured with HbA1c, assessed as change in HbA1c
Time Frame
4 months
Title
Weight loss
Description
Measured by body weight scale, assessed as change in percent body weight lost
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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