Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Nutrition-Based Approach to Reduce Heart Disease Risk Among Overweight African Americans: Use of Soul Food Plant-Based or Omnivorous Diets to Address Cardiovascular Disease
Brief Summary: This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

1. Risk factors for CVD, including LDL cholesterol and blood pressure; and
2. Body weight.

   Secondary Aim
3. Examine long-term changes in CVD risk factors and body weight at 24 months.


Options:
A: Inclusion Criteria:

* BMI of 27-40 kg/m2
* 30-75 years of age
* Stable body weight for the preceding 6 months
* Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
* HbA1c of 6.5 to 9.0
* Treatment by diet or oral agents only

Exclusion Criteria:

* Pregnancy or lactation
* Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
* Untreated thyroid disease or hypertension
* Hypertriglyceridemia with levels of TG \> 500 mg/dl
* Use of insulin
* Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
* Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).
B: Inclusion Criteria:

* Age 45+ yrs.
* BMI of \>30 kg/m2
* Body weight \<495 lbs.
* Normal blood chemistries
* Normal renal function
* Primary care physician acknowledgement
* Non-Vegetarian
* Mild to moderate movement impairment

Exclusion Criteria:

* Body weight \>495 pounds.
* Current smoker.
* Presence of unstable, acutely symptomatic, or life-limiting illness.
* Positive screen for dementia using Mini-Cog evaluation tool.
* Neurological conditions causing functional or cognitive impairments.
* History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation).
* Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months.
* Inability to walk independently.
* Bilateral hip replacements.
* Unable to give consent.
* Unable to complete written recording forms including journals of eating and exercise behaviors.
* Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications.
* Primary Care Physician advises against participation.
C: Inclusion Criteria:

* Diabetes mellitus, Type 2.
* HgbA1c \> 6.0% at screening. This is to confirm the diabetes diagnosis.
* Aged 18 years old and older
* BMI 25 and above.

Exclusion Criteria:

* Condition that will make it difficult for participation. Such as:

  * cancer
  * liver failure
  * unstable coronary artery disease
  * severe emphysema
  * bulimia or strong history of bulimia
  * vegan
* Laboratory evidence of organ dysfunction

  * Abnormal kidney function (serum creatinine)
  * thyroid stimulating hormone out of normal range
* Previous use or new changes in medications that can interfere with the measures used in the study:

  * current use of insulin and no immediate plans to start or increase diabetic mediations.
  * more than 3 oral hypoglycemic medications.
  * use of systemic (oral or IV) corticosteroids in the 6 months prior
  * severe autoimmune disorders
  * initiation of psychiatric medications in past 2 months.
* Weight loss confounds

  * Current use of weight loss medications or supplements.
  * History of or planned weight loss surgery.
* Other

  * Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum.
  * Unable or unwilling to do home glucose monitoring.
D: Inclusion Criteria:

* Self-identify as African American
* Be between the ages of 18-65 years
* Body Mass Index between 25- 49.9 kg/m2
* Live in the Columbia, SC/Midlands area
* Be able to attend all monitoring and weekly class visits
* Be willing to be randomized to either diet

Exclusion Criteria:

* Currently following a vegan diet
* Diagnosed with diabetes that is controlled by medication
* Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* Under the age of 18 years old
* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Diagnosed with stroke or heart attack

Answer: D