The CARING Study: Creating and Restoring Health Through Nutrition Guidance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhysicians Committee for Responsible Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Current or unresolved past drug abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Low-fat, vegan diet
BehavioralThe intervention diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Participants will also be guided to favor foods with a low glycemic index. Animal products and added oils will be excluded. The diet is designed to derive approximately 10% of energy from fat, approximately 10-15% of energy from protein, and the remainder from mostly complex carbohydrates. The diet will also provide approximately 40 g of fiber per day.
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Medical Utilization
This study will assess the effectiveness of a series of plant-based nutrition classes on health changes, measured by combined subscriber and insurance total cost of care (healthcare and health benefits).
Time frame
16 weeks, 1 year, and 2 years2
Body Weight
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight.
Time frame
16 weeks, 1 year, and 2 years3
Plasma Lipid Concentrations
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations.
Time frame
16 weeks, Every 6 months during the 2-year follow-up period4
HbA1C
This study will assess the association of attending a series of plant-based nutrition classes on with pre-post changes in glycemic control in individuals with type 2 diabetes as assessed by hemoglobic A1c (HbA1c) and use of medications.
Time frame
16 weeks, Every 6 months during the 2-year follow-up periodSecondary outcomes
1
Diet Acceptability
In addition, this study will assess the impact of association of attending a series of plant-based nutrition classes on pre-post changes in diet acceptability. Diet acceptability will be determined using the Food Acceptability Questionnaire (FAQ), asking participants to think about foods they have consumed in the prior two weeks to taking the FAQ, where higher scores indicate greater acceptability. There are eleven questions ranking answers on a scale of 1-7, and one question ranking answers on a scale from 1-13.
Time frame
16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Physicians Committee for Responsible Medicine
Lead sponsor
Blue Cross Blue Shield
Collaborator
Mayo Clinic
Collaborator
Source ClinicalTrials.gov