NCT07271940
Active, not recruiting
Not Applicable
Full Plate Living Nutrition Education Program
University of Wisconsin, Madison2 sites in 1 country42 target enrollmentStarted: January 12, 2026Last updated:
InterventionsFull Plate Living Nutrition Education Program
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Participant Weight
Overview
Brief Summary
The purpose of the research is to evaluate the acceptability and feasibility of implementing a 8-session nutritional education program in a general internal medicine clinic. This program emphasizes a fiber-rich, whole foods diet consisting of fruits, vegetables, legumes, whole grains, nuts and seeds. Such interventions can improve diabetes management and lead to weight loss. 48 participants will be enrolled and on study for approximately 5 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pre-diabetes or diabetes
- •Body Mass Index (BMI) 30-42
- •UW Health Primary Care Physician
Exclusion Criteria
- •Active cancer (treatment within one year or planning on having treatment)
- •Eating Disorder (SDE Screening 2+)
- •Chronic Kidney Disease (CKD) (Stage 4 or 5)
- •Patient Health Questionnaire-9 (PHQ9) indicating severe depression (greater than 15)
- •No PHQ9 and PHQ2 greater than 2
- •General Anxiety Disorder-7 (GAD7) indicating severe anxiety (greater than 15)
- •No GAD 7 and GAD2 greater than 2
- •Inflammatory bowel disease (IBD)
- •Irritable bowel syndrome (IBS)
- •Readiness to Change less than 7
Arms & Interventions
Full Plate Living Nutrition Education Program
Experimental
Intervention: Full Plate Living Nutrition Education Program (Other)
Outcomes
Primary Outcomes
Participant Weight
Time Frame: retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)
Secondary Outcomes
- Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)(baseline, 8 weeks, 20 weeks (3 month follow up))
- Participant Quality of Life measured by the SF-12 score(baseline, 8 weeks, 20 weeks (3 month follow up))
- Acceptability: Percent of Participants who found the intervention acceptable(Participant surveyed at the end of last session, approximately 8 weeks)
- Feasibility: Participant Retention Rate(baseline, 8 weeks, 20 weeks (3 month follow up))
- Feasibility: Participation Rate(Through enrollment (up to 3 months))
Investigators
Study Sites (2)
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