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

43 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Full Plate Living for Weight Loss?

The MyPlate-based obesity treatment, which is similar to Full Plate Living, encourages eating more filling foods without calorie counting and has been studied for its effectiveness compared to traditional calorie counting methods. ^{1 2 3 4 5}

How is the Full Plate Living treatment for weight loss different from other treatments?

Full Plate Living for weight loss is unique because it focuses on shared medical visits and encourages eating more high-satiety foods without calorie counting, unlike traditional methods that emphasize calorie restriction and portion control. ^{3 6 7 8 9}

What is the purpose of this trial?

The goal of this study is to determine whether shared medical visits also called "group visits" would be beneficial for patients who are under weight management care. As part of this study, participants will be asked to complete a survey to give the study team a better idea of their current health conditions and if this study will be good fit for them. Once the survey has been completed, participants will then be randomly assigned to one of two groups. Group one will include participation in shared medical visits over a period of eight weeks. In addition to the medical visits, this group will also include two cooking classes. Group two will be asked to complete online Full Living Plate modules. Participants will be asked to complete another survey at the end of the study.

Research Team

Ryan Kane, MD

Principal Investigator

Duke University

Eligibility Criteria

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

My BMI is 30 or higher.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Early weight loss outcomes from a newly established hospital-affiliated specialized obesity care delivery model in Central Florida. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Rural engagement in primary care for optimizing weight reduction (REPOWER): A mixed methods study of patient perceptions. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness trial comparing MyPlate to calorie counting for mostly low-income Latino primary care patients of a federally qualified community health center: study design, baseline characteristics. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Canadian dietitians' understanding of non-dieting approaches in weight management. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Weight loss counseling by health care providers. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Role of nutrition planning in the treatment for obesity. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Guidelines for the follow-up of patients undergoing bariatric surgery. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A shared care approach in obesity management: the general practitioner and a hospital based service. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

"Dietitians May Only Have One Chance"-The Realities of Treating Obesity in Private Practice in Australia. [2022]