Full Plate Living Nutrition Education Program

April 13, 2026 updated by: University of Wisconsin, Madison
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • UW Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pre-diabetes or diabetes
  • Body Mass Index (BMI) 30-42
  • UW Health Primary Care Physician

Exclusion Criteria:

  • Pregnant
  • 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
  • Confidence to Change less than 7
  • Lack of transportation
  • Non-English Speaking
  • No control over food environment
  • No access to laptop, desktop computer, or tablet
  • No email or text message access
  • Unwilling to participate in a shared medical visit
  • Unable to attend one of the four concurrent shared medical visit session cohorts
  • For those on insulin, no access to finger-prick blood glucose meter or continuous glucose monitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full Plate Living Nutrition Education Program
Other: Full Plate Living Nutrition Education Program
Participants will attend 8 sessions over 8 weeks. Participants will learn about the importance of fiber and how to add fiber to their diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant Weight
Time Frame: retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)
retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Time Frame: baseline, 8 weeks, 20 weeks (3 month follow up)
Dietary fiber (grams per day) will be measured using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) which has been validated for measuring fiber intake in adults. The ASA24 is a free, web-based tool. Participants will complete the ASA24 online two times prior to the first session, 2 times prior to the last session, and 2 times 3 months after the last session.
baseline, 8 weeks, 20 weeks (3 month follow up)
Participant Quality of Life measured by the SF-12 score
Time Frame: baseline, 8 weeks, 20 weeks (3 month follow up)
Possible scores range from 0-100 with higher scores indicating better quality of life.
baseline, 8 weeks, 20 weeks (3 month follow up)
Acceptability: Percent of Participants who found the intervention acceptable
Time Frame: Participant surveyed at the end of last session, approximately 8 weeks
A subset of participants will be invited to complete an individual interview after the last session. The aim is to schedule 8-12 participants for interviews including both participants who completed all the sessions and those stopped attending sessions. Data will be derived from these qualitative semi-structured interviews.
Participant surveyed at the end of last session, approximately 8 weeks
Feasibility: Participant Retention Rate
Time Frame: baseline, 8 weeks, 20 weeks (3 month follow up)
Feasibility will in part be measured by participant retention rate, the number of participants who complete each time point of data collection over the number of participants enrolled.
baseline, 8 weeks, 20 weeks (3 month follow up)
Feasibility: Participation Rate
Time Frame: Through enrollment (up to 3 months)
Feasibility will in part be measured by participation rate, the number of participants enrolled over the target enrollment.
Through enrollment (up to 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Katie Miller, MD, UW School of Medicine and Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1466
  • Approval 11/20/25 (Other Identifier: UW Madison)
  • SMPH/DOM General Internal (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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