Full Plate Living Nutrition Education Program

NCT07271940 | Active Not Recruiting

• 3 other identifiers: 2025-1466Approval 11/20/25SMPH/DOM General Internal
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Pre Diabetes; Obesity

Keywords

fiber; nutrition

Outcome Measures

Primary Outcomes (1)

• Participant Weight

  retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)

Secondary Outcomes (5)

• 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)

Study Arms (1)

Full Plate Living Nutrition Education Program

EXPERIMENTAL

Other: Full Plate Living Nutrition Education Program

Interventions

Full Plate Living Nutrition Education Program OTHER

Participants will attend 8 sessions over 8 weeks. Participants will learn about the importance of fiber and how to add fiber to their diet.

Full Plate Living Nutrition Education Program

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katie Miller, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)