The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Physicians Committee for Responsible Medicine
Study ID
NCT05795439
Status
Recruiting
Apply to this trial

Conditions

  • Type 2 Diabetes Treated With Insulin
  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Low-fat, vegan diet — BEHAVIORAL
    The 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.

Study Details

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.

Key Dates

Start date
Jul 11, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    The Intervention group arm of participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks.
  • No Intervention: Control Group
    The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Primary Outcome Measure

Medical Utilization [ Time Frame: 16 weeks, 1 year, and 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Physicians Committee for Responsible MedicineWashington D.C.District of Columbia20016
Physicians CFR Medicine
[email protected]
2025277363

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Physicians Committee for Responsible Medicine· Washington D.C., DC

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