Type2 Diabetes
Conditions
Brief summary
A clinical study evaluating a three month digitally delivered lifestyle change program in adults with Type 2 Diabetes. The FareWell Program (the Program) aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. The current study is designed to evaluate to what degree adults with Type 2 Diabetes engaged with the Program can improve glycemic control and/or decrease medication needs.
Detailed description
The Program aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. It includes meal planning tools, smart shopping lists, recipes curated by a physician, dietitian and chef educator, daily self-monitoring features with personalized weekly goals, bi-weekly live one-on-one health coaching and support from an online member community, and an educational curriculum. Subjects in the Program may receive support from other members of a Care Team (lifestyle medicine physician, chef educator, registered dietitian and/or psychologist/psychiatrist) as needed. The Care Team does not provide medical advice, nor replace traditional medical care. Instead, the Care Team encourages behavior change by providing support and sharing its expertise. Study participants will have access to the Program for a twelve week period and will be asked to complete short health surveys at baseline and at the end of the study.
Interventions
BEHAVIORALFareWell Program
The FareWell Program is a digitally delivered lifestyle management curriculum, which includes meal planning tools, daily self monitoring, personalized goal setting and bi-weekly live one-on-one health coaching.
Sponsors
FareWell
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
evaluation of pre/post measures of a single group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of type 2 diabetes
Exclusion criteria
* Inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend English. * Does not have a smartphone (either an iPhone or Android phone)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of engagement with the assigned mobile app | 12 weeks | How do participants interact with the digital program (e.g. feature use, coaching calls completed, targets tracked, targets met) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported Hemoglobin A1c | 12 weeks | Comparison of baseline and end program self reported Hemoglobin A1c |
| Change in self-reported diabetes medication type or dose | 12 weeks | Comparison of diabetes medications reported at baseline to any changes reported at the end of the study or mid-study |
Countries
United States
Outcome results
None listed