Chronic Disease, Nutrition, Healthy
Conditions
Keywords
Whole food plant-based nutrition, Primary care setting
Brief summary
Evaluation of the impact of a whole food, plant-based (WFPB) program using shared medical appointments (SMAs) on reducing cardiovascular risk factors and weight loss in overweight/obese adults with at least one chronic disease
Detailed description
The study will use a single-arm with participants enrolled in three groups of 15 each (n=45) into the Green Wellness Program: Plants-2-Plate, an established program focusing on WFPB predominant eating pattern in an academic primary care setting. The program will offer 14 SMAs in a period of 6 months. Participants will attend the SMA weekly for 3 months, followed by a monthly SMA for the last 3 months of the intervention period. In the first session, participants will receive information about the program, and establish a health goal to be met at the end of the program. Each weekly SMA will have a nutrition education lesson, and feedback from the FNP, RN and RD after a brief assessment on health, medication adjustment, food choices, and shared ideas and experiences among the participants. At the end of the session, participants will set a small health goal to be followed during the week with assistance from the inter-professional team. The WFPB dietary approach includes vegetables, fruits, legumes, whole grains, seeds, nuts in small portion, elimination of all or most of animal foods, and reduction of processed food. Participants will eat ad libitum. In addition, they will receive support to manage stress, improve quality of sleep, and increase physical activity during the SMA.
Interventions
OTHERGreen Wellness Program: Plants-2-Plate
A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern
Sponsors
Louise L Morrison Trust
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study will use a single-arm with participants to be enrolled in three groups of 15 each (n=45) into the Green Wellness Program: Plants-2-Plate
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women \>18 years * Either overweight (BMI \> 25kgm-2) or obese (BMI \>30 kgm-2) * Diagnosis of one or more chronic diseases * Own a smartphone or tablet that has reliable interned/data access * Agrees to comply with all study requirements * Can speak and understand English
Exclusion criteria
* Diagnosis of cancer * Previous participant in Green Wellness program: Plants-2-Plate * Pregnant or planning to become pregnant * Breastfeeding * Concurrent weight loss program * Plans to leave the city or USA for over 2 weeks within 6 months of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test | Baseline to 6 months | Change in sICAM1 from program beginning to end |
| Low Density Lipoprotein (LDL) from blood chemistry panel | Baseline to 6 months | Change in LDL-cholesterol from program beginning to end |
| HDL-Cholesterol from blood chemistry panel | Baseline to 6 months | Change in HDL-cholesterol from program beginning to end |
| Triglycerides from blood chemistry panel | Baseline to 6 months | Change in triglycerides from program beginning to end |
| Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker | Baseline to 6 months | Change in TNF-α from program beginning to end |
| Interleukin (IL)-18 measurement from blood test | Baseline to 6 months | Change in Interleukin (IL)-18 from program beginning to end |
| C-reactive protein (HsCRP) measurement from blood test | Baseline to 6 months | Change in HsCRP from program beginning to end |
| Total Cholesterol from blood chemistry panel | Baseline to 6 months | Change in Total Cholesterol from program beginning to end |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity measurement | Baseline to 6 months | Time spent daily on physical activity daily |
| Systolic Blood pressure measurement | Baseline to 6 months | Change in Systolic blood pressure from program beginning to end |
| Diastolic Blood pressure measurement | Baseline to 6 months | Change in Diastolic blood pressure from program beginning to end |
| Waist circumference measurement | Baseline to 6 months | Change in waist circumference from program beginning to end |
| Weight measurement | Baseline to 6 months | Change in weight from program beginning to end |
| Adherence to WFPB measurement | Baseline to 6 months | Pattern of adherence is tracked by a mobile health device by number of days of adherence to program |
Countries
United States
Outcome results
None listed