RecruitingNot applicable

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 16 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The Intervention group participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The CARING study tests whether nutrition education can improve health for adults with type 2 diabetes who have Blue Cross Blue Shield insurance. It also looks at whether this can lower health care costs for members and the insurance company.

The CARING study assesses the health benefits of nutrition education for Blue Cross Blue Shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had Blue Cross Blue Shield insurance without a break for the past 12 months.
  • Be age 18 or older. Men and women may join.
  • Have type 2 diabetes.
  • Be able and willing to take part in all study activities.
  • Follow a plant-based diet and attend weekly online classes for the first 16 weeks.
  • Keep your physical activity level the same for the first 16 weeks.

Who can't join

  • Have type 1 diabetes or a history of a hormone condition that affects body weight.
  • Have smoked in the past 6 months, or have current or unresolved past drug abuse.
  • Drink more than 2 alcoholic drinks a day, even just on some days, or currently drink after a history of alcohol abuse or dependence.
  • Recently gave birth, are pregnant, or plan to become pregnant before or during the study; or had weight-loss surgery in the past 6 months.
  • Have an unstable physical or mental health condition, signs of an eating disorder, or dementia (loss of memory and thinking skills).
  • Have a cancer diagnosis or stage 4 or 5 chronic kidney disease (severe kidney disease).
  • Live in an institution for ongoing care, are near the end of life, or receive palliative care (care to ease symptoms of serious illness).
  • Are not fluent in English, or actively take part in certain Blue Cross Blue Shield of Michigan diabetes and case management programs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months 2. Male or female 3. Age at least 18 years 4. Have a diagnosis of type 2 diabetes 5. Ability and willingness to participate in all components of the study, including: 1. Following a plant-based diet for the initial 16 weeks of the study; 2. Attending weekly online classes for the initial 16 weeks of the study; and 3. Keeping physical activity level consistent throughout the initial 16 weeks of the study. Exclusion Criteria: 1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome 2. Smoking during the past six months 3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 4. Current or unresolved past drug abuse 5. Recently gave birth, pregnant, or plans to become pregnant before or during the study period 6. Unstable medical or psychiatric status 7. Cancer diagnosis 8. Chronic kidney disease, stage 4 or 5 9. Evidence of an eating disorder 10. Lack of English fluency 11. Bariatric surgery in the last 6 months 12. Dementia 13. Institutional custodial care 14. End of life 15. Palliative Care 16. Actively engaged in specific BCBSM diabetes programs and case management programs

Study sites (1)

DC