Group vs Individual Obesity Care for Obesity

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CM
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Overseen ByPetra Duran, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Charles Drew University of Medicine and Science
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help manage obesity: group visits with medical professionals and one-on-one sessions with a dietitian. Researchers aim to determine which approach more effectively aids weight loss and improves heart health. The trial seeks adults with a BMI of 30 or above who are interested in weight loss and willing to try either method. Participants should not currently use weight loss medication or supplements. As an unphased trial, this study offers a unique opportunity to explore personalized weight management strategies.

Will I have to stop taking my current medications?

The trial requires that you stop taking weight loss medications and supplements advertised for weight loss before enrolling. Other medications, like those for blood pressure or diabetes, can be adjusted by your primary care provider if needed.

What prior data suggests that these obesity care methods are safe?

Research has shown that both dietitian-led individual visits and medical group visits safely manage obesity.

In dietitian-led visits, studies have found that dietitians provide effective and safe weight management strategies. These visits focus on personalized care, which patients manage well and typically do not cause health problems.

In medical group visits, research indicates that these sessions are also safe and well-received. Patients often lose weight and sometimes require less diabetes medication. No major safety issues have been reported with this approach.

Overall, both methods maintain a strong safety record and are generally well-received by participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different approaches to obesity management: group care versus individual care. In the group setting, participants benefit from interactive sessions led by both an endocrinologist and a nutritionist, which can foster community support and shared experiences. In contrast, the individual setting offers personalized attention from a registered dietitian, allowing for tailored dietary advice. This trial aims to uncover which setting might be more effective or preferable for managing obesity, providing insights that could enhance current treatment strategies.

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

This trial will compare two approaches to obesity management: dietitian-led individual visits and medical group visits. Studies have shown that weight management programs led by dietitians can result in significant weight loss. On average, participants in these programs lost about 1.03 kg more than those who did not participate. Research also indicates that attending medical group visits, where care is provided in a group setting, leads to noticeable weight loss. Participants in these groups lost an average of 11.63 pounds, with more than half losing at least 7% of their weight. Both dietitian-led individual visits and medical group visits effectively help people lose weight and manage obesity.26789

Who Is on the Research Team?

TF

Theodore Friedman, MD. PhD

Principal Investigator

Charles Drew University of Medicine and Science

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI ≥ 30 kg/m2) from any ethnic background, interested in weight loss and willing to try a group medical visit or individual dietitian-led care. They must not be on certain weight loss medications or supplements recently, nor participating in other obesity treatments. Women over 50 and men over 40 may also get a heart scan.

Inclusion Criteria

BMI ≥ 30 kg/m2
I identify as male, female, or LGBT.
I can receive care at LAC-DHS and have a PCP who can adjust my medications.
See 5 more

Exclusion Criteria

Currently participating in another obesity treatment program
I am currently taking medication for weight loss.
I had weight loss surgery less than a year ago.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Baseline Assessment

Participants are randomized into either the composite group visit or dietitian-led visit and undergo baseline assessments

1 week
1 visit (in-person)

Treatment

Participants receive obesity management in either a group setting led by an endocrinologist and nutritionist or in an individual setting led by a registered dietitian

12 months
Monthly visits (in-person)

Sub-study (Optional)

A subset of participants undergo Coronary Artery Calcium (CAC) scanning and perivascular fat measurements

12 months
2 visits (in-person) for CAC scanning

Follow-up

Participants are monitored for changes in health outcomes such as HbA1c, diet quality, physical activity, and psychological distress

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Dietitian Individual Visit
  • Medical Group Visit
Trial Overview The study compares two ways of managing obesity: one through group medical visits and the other via one-on-one sessions with a dietitian. It will check if these interventions can reduce heart-related fat and slow down plaque buildup in arteries.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Medical Group VisitExperimental Treatment1 Intervention
Group II: Dietitian-Led VisitExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Charles Drew University of Medicine and Science

Lead Sponsor

Trials
54
Recruited
8,500+

Citations

How Effective Are Dietitians in Weight Management? A ...Groups receiving the dietitian intervention lost an additional 1.03 kg (95% CI:−1.40; −0.66, p < 0.0001) of weight and 0.43 kg/m2 (95% CI:−0.59, −0.26; p < ...
Dietitians' role in obesity care: insights from the Academy of ...Estimates suggest that by 2035, overweight and obesity will affect 54% of the global adult population, totaling 3.3 billion individuals (1).
Weight Management Interventions Provided by a Dietitian ...Compared with control conditions, weight management interventions provided by a dietitian resulted in improved body mass index (mean difference [MD] –1.5; 95% ...
Weight Management Interventions Provided by a Dietitian ...Compared with control conditions, weight management interventions provided by a dietitian resulted in improved body mass index (mean difference [MD] –1.5; 95% ...
Weight Loss in Short-Term Interventions for Physical ...Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.
Exploring dietitians' experiences caring for patients living with ...The primary aim of this study was to explore the experiences of dietitians caring for patients living with obesity in acute hospital settings.
Healthcare professionals' perspectives on the current state ...Results. Of the 100 healthcare professionals surveyed, 88 % reported actively working in obesity management and completed the full survey. Undergraduate ...
(PDF) Comparing Medical Group Visits to Dietitian-Led ...OBJECTIVE This study aims to compare the efficacy of medical group visits with individualized dietitian-led visits (standard of care) in safety- ...
Medical Nutrition Therapy Interventions Provided by ...Overweight and obesity affect most adults living in the United States and are causally linked to several adverse health outcomes. Registered dietitian ...
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