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OpenTrials
Active, Not Recruiting

NCT Number: NCT07271940

Full Plate Living Nutrition Education Program

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus Body Weight Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre Diabetes Signs and Symptoms

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participant Weight

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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