Diabetes MellitusNCT07271940
Full Plate Living Nutrition Education Program
A study testing Full Plate Living Nutrition Education Program in people with Diabetes Mellitus and Pre Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Pre Diabetes, Obesity
- What is being tested?
- Full Plate Living Nutrition Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-diabetes or diabetes
- Body Mass Index (BMI) 30-42
- UW Health Primary Care Physician
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Full Plate Living Nutrition Education Program
- Keywords
- fiber, nutrition
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Plate Living Nutrition Education ProgramOther
Participants will attend 8 sessions over 8 weeks. Participants will learn about the importance of fiber and how to add fiber to their diet.
| Study group | Role | What they receive |
|---|---|---|
| Full Plate Living Nutrition Education Program | Experimental | Not described Receives: Other: Full Plate Living Nutrition Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Weight
Measured: 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)
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.
Measured: baseline, 8 weeks, 20 weeks (3 month follow up)
Participant Quality of Life measured by the SF-12 score
Possible scores range from 0-100 with higher scores indicating better quality of life.
Measured: baseline, 8 weeks, 20 weeks (3 month follow up)
Acceptability: Percent of Participants who found the intervention acceptable
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.
Measured: Participant surveyed at the end of last session, approximately 8 weeks
Feasibility: Participant Retention Rate
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.
Measured: baseline, 8 weeks, 20 weeks (3 month follow up)
Feasibility: Participation Rate
Feasibility will in part be measured by participation rate, the number of participants enrolled over the target enrollment.
Measured: Through enrollment (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start12 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie Miller, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271940
- Sponsor's protocol ID
- 2025-1466
- Other IDs
- Approval 11/20/25, SMPH/DOM General Internal
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Plate Living Nutrition Education Program
- ClinicalTrials.gov ID
- NCT07271940
- Acronym / sponsor ID
- 2025-1466
- Conditions
- Diabetes Mellitus, Pre Diabetes, Obesity
- Keywords
- fiber, nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Plate Living Nutrition Education Program | Experimental | Other: Full Plate Living Nutrition Education Program |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-diabetes or diabetes
- Body Mass Index (BMI) 30-42
- UW Health Primary Care Physician
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Plate Living Nutrition Education ProgramParticipants will attend 8 sessions over 8 weeks. Participants will learn about the importance of fiber and how to add fiber to their diet. | Other | Full Plate Living Nutrition Education Program |
Primary outcome
Participant Weight
Time frame: retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)
5 secondary outcomes
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Time frame: 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)
Acceptability: Percent of Participants who found the intervention acceptable
Time frame: 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: Participation Rate
Time frame: Through enrollment (up to 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Miller, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Plate Living Nutrition Education Program in people with Diabetes Mellitus and Pre Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Weight (time frame: retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.