Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date September 29, 2020
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date August 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Glycemic control [ Time Frame: 4 months ]
    Measured with HbA1c, assessed as change in HbA1c
  • Weight loss [ Time Frame: 4 months ]
    Measured by body weight scale, assessed as change in percent body weight lost
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Official Title  ICMJE The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
2x2 full factorial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type2 Diabetes Mellitus
  • Hypertension
  • PreDiabetes
  • Overweight and Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: DASH diet
  • 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).
    Intervention: Behavioral: Very low carbohydrate, ketogenic diet
  • 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.

    Interventions:
    • Behavioral: DASH diet
    • Behavioral: Extras
  • 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.

    Interventions:
    • Behavioral: Very low carbohydrate, ketogenic diet
    • Behavioral: Extras
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2020)
94
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
140
Actual Study Completion Date  ICMJE August 9, 2020
Actual Primary Completion Date August 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729479
Other Study ID Numbers  ICMJE HUM00146610
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Saslow, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP