Full Plate Living for Weight Loss

Overseen By Iris Pounds

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Unstable conditions, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether group medical visits can help people manage their weight more effectively. Participants will either join shared medical visits and attend cooking classes or complete online modules focused on healthy eating. The aim is to determine if interacting with others and learning in a group setting leads to better weight management outcomes. The trial seeks individuals currently receiving care for obesity (BMI of 30 or higher) at the Duke Lifestyle and Weight Management Center and residing in Durham County. Participants must be willing to engage in group sessions over an eight-week period. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to weight management and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with your healthcare provider.

What prior data suggests that shared medical visits and Full Plate Living are safe for weight management?

Research shows that both Full Plate Living and shared medical visits are safe for people. Full Plate Living promotes a high-fiber diet, which most people tolerate well. One study found that participants following this diet did not experience major side effects. Another study demonstrated that increased fiber intake aids weight loss, highlighting its benefits.

Shared medical visits also show promise. Research indicates that these group appointments can help people lose weight and improve health. Participants in these visits did not report significant negative effects. Additionally, these visits can lead to better outcomes than traditional one-on-one appointments.

Overall, both approaches have been used without major safety concerns, focusing on lifestyle changes that are generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Full Plate Living program for weight loss because it combines shared medical visits with interactive cooking classes, which is a fresh approach compared to traditional diet and exercise plans. This program emphasizes community support and hands-on learning, offering a unique blend of education and social engagement that could enhance motivation and adherence. Additionally, the control group’s completion of online modules allows for flexibility, catering to different learning preferences and lifestyles, which might make it more accessible and sustainable for participants looking to lose weight.

What evidence suggests that this trial's treatments could be effective for weight loss?

Research has shown that the Full Plate Living program, which promotes eating high-fiber foods, helps many people lose weight. One study found that 62.5% of participants lost weight over 16 weeks. This program emphasizes consuming whole, unprocessed plant foods rich in fiber. In this trial, some participants will complete online Full Plate Living modules over eight weeks.

Other participants will attend shared medical visits over eight weeks. Studies suggest these group visits can help people lose weight more effectively than regular one-on-one doctor visits. These visits provide support and education, inspiring healthier lifestyle choices. Both methods show promise in helping people manage their weight successfully. ^{2 5 6 7 8}

Who Is on the Research Team?

Nia S Mitchell, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals experiencing severe weight loss or who are managing their weight. Participants should be interested in group medical visits and willing to engage with either cooking classes or online health modules. Specific eligibility criteria details were not provided.

Inclusion Criteria

DLWMC provider must medically clear their participation in this program

Patients must be willing and able to consent to participating in 4 shared medical appointments with 10-13 other DLWMC patients over the course of 8 weeks

Patients must live in Durham County

Exclusion Criteria

Patients with unstable medical or mental health condition, as deemed by their DLWMC medical provider (e.g., uncontrolled eating disorder, active severe major depression, gastrointestinal disease that would preclude consumption of a high fiber diet)

Patients who are pregnant or plan to become pregnant will be excluded, as change in weight will be a secondary outcome and patients may have specific dietary needs not covered by the content offered by this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Treatment

Participants are randomly assigned to either shared medical visits with cooking classes or online Full Living Plate modules over eight weeks

8 weeks

4 group visits (in-person) or online modules

Follow-up

Participants are monitored for outcomes such as nutrition security and intervention appropriateness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Full Plate Living
• Shared Medical Visits

Trial Overview The study tests if shared medical visits ('group visits') can help people manage their weight better, comparing two approaches: one involving group medical visits with cooking classes, and the other using online Full Plate Living modules.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Attend shared medical visits over eight weeks and attend two cooking classes.

Group II: Control Active Control 1 Intervention

Completion of online Full Living Plate modules over eight weeks

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Ardmore Institute of Health

Collaborator

Trials

6

Recruited

96,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37139446/

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.

2. 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.

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

Increased dietary fiber is associated with weight loss ... The initial finding confirms that the 16-week FPL program results in weight loss among the majority of participants, with 62.5% reporting ...

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

Evaluating the Full Plate Living lifestyle intervention in low ... Our results also confirm the findings of a meta-analysis reporting a positive correlation between dietary fiber consumption and weight reduction ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/08901171221116066

Health Benefits of a 16-Week Whole Food, High Fiber ... Increased dietary fiber is associated with weight loss among Full Plate Living program participants. Go to citationCrossrefGoogle Scholar ...

6. fullplateliving.org fullplateliving.org/

Full Plate Living 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.

7. 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.

8. fullplateliving.org fullplateliving.org/blog/protein

Protein and Your Health There is very little risk of protein deficiency because 97% of Americans meet or exceed minimum daily protein recommendations.4. National data ...