Nutrition Education for Diabetes and Obesity

Overseen By Jennifer Allmaras, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnant, Active cancer, Eating disorder, CKD, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of the Full Plate Living Nutrition Education Program in helping people manage diabetes and lose weight. The program teaches participants to eat more fiber-rich foods, such as fruits, vegetables, and whole grains. It targets individuals with pre-diabetes or diabetes who have a Body Mass Index (BMI) between 30 and 42 and receive care from a UW Health primary care doctor. As an unphased trial, participants can contribute to valuable research that may enhance diabetes management strategies.

What prior data suggests that this nutritional education program is safe?

Research has shown that the Full Plate Living Nutrition Education Program is generally well-received. This program encourages consuming foods high in fiber, such as fruits, vegetables, beans, whole grains, nuts, and seeds. One study found that increasing fiber intake through this program is linked to weight loss, indicating positive health changes without major side effects. The program aims to help manage diabetes and support weight loss. Reports of serious negative effects from participating in this program are absent, suggesting it is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Full Plate Living Nutrition Education Program is unique because it focuses on teaching people how to make healthier food choices specifically tailored for managing diabetes and obesity. Unlike standard options like medication or surgery, this program empowers individuals through education, helping them understand the impact of nutrition on their health. Researchers are excited because this approach could lead to sustainable lifestyle changes, potentially reducing the need for medication and improving overall well-being.

What evidence suggests that the Full Plate Living Nutrition Education Program might be an effective treatment for diabetes and obesity?

Studies have shown that increasing dietary fiber intake can aid in weight loss and improve diabetes management. Participants in this trial will engage with the Full Plate Living Nutrition Education Program, which emphasizes a high-fiber diet with whole foods such as fruits, vegetables, and whole grains. Research indicates that this approach can help control blood sugar and support weight loss, benefiting diabetes and obesity management. The program encourages small changes that can lead to significant health improvements over time. By focusing on fiber, it helps maintain better blood sugar levels and may improve weight and fat management. ^{1 6 7 8 9}

Who Is on the Research Team?

Katie Miller, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like diabetes, prediabetes, obesity, or impaired glucose tolerance. It's designed to see if a nutrition education program focusing on high-fiber whole foods can be successfully used in a general medicine clinic.

Inclusion Criteria

Body Mass Index (BMI) 30-42

UW Health Primary Care Physician

I have pre-diabetes or diabetes.

Exclusion Criteria

Pregnant

Eating Disorder (SDE Screening 2+)

Patient Health Questionnaire-9 (PHQ9) indicating severe depression (greater than 15)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nutritional Education Program

Participants attend an 8-session nutritional education program focusing on a fiber-rich, whole foods diet

8 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for dietary changes and quality of life improvements

12 weeks

2 assessments (online)

What Are the Treatments Tested in This Trial?

Interventions

• Full Plate Living Nutrition Education Program

Trial Overview The Full Plate Living Nutrition Education Program being tested emphasizes eating fiber-rich foods such as fruits, vegetables, legumes, whole grains, nuts and seeds. The study will involve 48 participants over approximately 5 months to assess its impact on diabetes management and weight loss.

How Is the Trial Designed?

Group I: Full Plate Living Nutrition Education Program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07271940

Full Plate Living Nutrition Education Program See Delay Results Type in the Results Data ... Diabetes Mellitus. Glucose Intolerance. Obesity. Plan for Individual Participant Data (IPD).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10150096/

Increased dietary fiber is associated with weight loss ... This research aimed to assess the relationship between dietary fiber and weight loss among individuals participating in the Full Plate Living (FPL) program.

3. ardmoreinstituteofhealth.org ardmoreinstituteofhealth.org/news/the-science-behind-full-plate-living

The Science Behind Full Plate Living Full Plate Living promotes a high-fiber approach to healthy eating, highlighting the consumption of whole, unprocessed plant foods.

4. fullplateliving.org fullplateliving.org/

Full Plate Living Full Plate Living helps you add more fiber to the meals you're already eating. It's a small-step approach that can lead to big health outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1751991822000687

Effectiveness of restricted diet with a plate in patients ... The plate model is at least as effective as the counting model over the short term for glycemic control and perhaps even better for weight and lipid control.

6. ardmoreinstituteofhealth.org ardmoreinstituteofhealth.org/full-plate-living

Full Plate Living The Full Plate Living program provides a comprehensive platform with all the tools and resources to help engage employees to more easily find their own success.

7. fullplateliving.org fullplateliving.org/home

Take Control of Your Health One Meal at a Time with Our ... Full Plate Living is a free membership offered by the non-profit Ardmore Institute of Health. It will teach you how to start eating a high-fiber diet.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9006362/

Evaluating the Full Plate Living lifestyle intervention in low ... The aim of this quasi-experimental study was to examine physical and mental health changes among Latinas with, and without, food insecurity ...

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1110748/full

Increased dietary fiber is associated with weight loss ... This research aimed to assess the relationship between dietary fiber and weight loss among individuals participating in the Full Plate Living (FPL) program.