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

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ClinicalTrials.gov Identifier: NCT03729479
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Laura Saslow, 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Hypertension PreDiabetes Overweight and Obesity Behavioral: DASH diet Behavioral: Very low carbohydrate, ketogenic diet Behavioral: Extras Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 full factorial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : August 9, 2020
Actual Study Completion Date : August 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: 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: 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: Experimental: 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).
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).

Experimental: Experimental: DASH diet and extra support

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
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: Extras
Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.

Experimental: Experimental: very low carb, ketogenic diet and extra support

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
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.




Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 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 :
  1. Glycemic control [ Time Frame: 4 months ]
    Measured with HbA1c, assessed as change in HbA1c

  2. Weight loss [ Time Frame: 4 months ]
    Measured by body weight scale, assessed as change in percent body weight lost



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729479


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Responsible Party: Laura Saslow, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03729479    
Other Study ID Numbers: HUM00146610
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Saslow, University of Michigan:
dietary intervention
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight