RecruitingNot Applicable

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

United States700 participantsStarted 2023-07-11

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
. Male or female
. Age at least 18 years
. Have a diagnosis of type 2 diabetes
. Ability and willingness to participate in all components of the study, including:
. Following a plant-based diet for the initial 16 weeks of the study;
. Attending weekly online classes for the initial 16 weeks of the study; and
. Keeping physical activity level consistent throughout the initial 16 weeks of the study.

Exclusion criteria

. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
. Smoking during the past six months
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Medical Utilization

Timeframe: 16 weeks, 1 year, and 2 years

Body Weight

Timeframe: 16 weeks, 1 year, and 2 years

Plasma Lipid Concentrations

Timeframe: 16 weeks, Every 6 months during the 2-year follow-up period

HbA1C

Timeframe: 16 weeks, Every 6 months during the 2-year follow-up period

Trial details

NCT IDNCT05795439

SponsorPhysicians Committee for Responsible Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Macy Sutton, MS

202-527-7363 msutton@pcrm.org

View on ClinicalTrials.gov More Type2diabetes trials