What side effects are associated with this type of intervention?

The most common treatments for obesity, particularly those involving multicomponent behavioral interventions, generally have minimal side effects related to the behavioral components, such as increased physical activity and dietary changes. However, pharmacologic treatments like GLP-1 receptor agonists (liraglutide and semaglutide) can cause gastrointestinal side effects, including nausea and vomiting. Other medications used for obesity, such as orlistat, may cause gastrointestinal issues like oily stools and flatulence. It's important to discuss potential side effects with a healthcare provider to tailor the treatment plan to individual needs and tolerances.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including bupropion-naltrexone, which combines a dopamine-reuptake inhibitor and an opioid-receptor antagonist to reduce food intake. Additionally, semaglutide, a GLP-1 receptor agonist, has shown significant weight loss benefits in clinical trials. These pharmacological treatments are often used alongside behavioral interventions, such as those involving lifestyle modifications and dietary counseling. The Multicomponent, Multilevel Behavioral Weight Loss Intervention being studied leverages Health IT tools to enhance these behavioral modifications, aiming to improve weight loss outcomes through structured support and monitoring.

What other types of research exist?

Promising, novel alternatives for obesity treatment in 2024 include: 1) Telehealth delivery of behavioral interventions, which has shown to be as effective as face-to-face programs. 2) Internet-based behavioral weight-control interventions, which provide a viable alternative to in-person treatment. 3) Mobile apps for smoking cessation and weight management, offering features like tracking, motivational messaging, and coping strategies. 4) Technology-enhanced CBT, which has shown mixed but promising results in various studies. These alternatives leverage technology to provide accessible and effective treatment options.

← Back to Search

Health IT-Supported Weight Loss Intervention for Obesity (CHAMPS Trial)

N/A

Recruiting

Led By Karen Johnson, MD

Research Sponsored by University of Tennessee

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients are ≥ 16 years old

Patients are overweight or obese (BMI ≥ 25 kg/m2)

Must not have

History of amputation or bariatric surgery or planning to have bariatric surgery within the next 12 months

Current weight loss medication use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a weight loss program using online health tools and phone support for underserved groups. It aims to help people lose weight by providing easy access to diet and exercise advice through their health records. The study focuses on groups with high obesity rates who often face challenges in accessing effective weight loss programs.

Who is the study for?

This trial is for overweight or obese individuals (BMI ≥ 25 kg/m2) who are at least 16 years old, have internet access, and belong to underserved groups. They must be patients at participating sites and willing to be randomly assigned to a group. People with certain medical conditions, uncontrolled psychiatric disorders, substance abuse issues, recent major surgeries or cancer (except skin cancer), current weight loss medication use, or plans that conflict with the study's timeline cannot join.

What is being tested?

The trial tests if a behavioral weight loss program delivered through Health IT tools via patient portals leads to more weight loss after one year compared to a standard support group. The Active Intervention Group receives an adapted version of the Look AHEAD intensive lifestyle intervention while the Comparison Group gets basic diabetes support education.

What are the potential side effects?

Since this is a behavioral intervention focusing on lifestyle changes rather than medication or surgery, side effects may include typical responses to diet change and increased physical activity such as muscle soreness, fatigue during adjustment periods, potential dietary deficiencies if not monitored properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 16 years old or older.

Select...

My BMI is 25 or higher, indicating I am overweight or obese.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had an amputation, bariatric surgery, or plan to within a year.

Select...

I am currently taking medication to lose weight.

Select...

I have not had cancer (other than skin cancer) in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relative percentage change in weight

Secondary study objectives

Relationship of social determinants of health (BRFSS) with weight change over time

Relationship of social determinants of health (screening tool) with weight change over time

Relationship of social determinants of health (z codes) with weight change over time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active Intervention GroupExperimental Treatment1 Intervention

Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to under-served population groups

Group II: Comparison GroupActive Control1 Intervention

Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, particularly those involving behavioral modification through Health IT tools, work by combining dietary changes, increased physical activity, and behavioral strategies. These interventions aim to reduce caloric intake, enhance physical fitness, and modify eating behaviors. Health IT tools, such as EHR and patient portals, support these efforts by offering personalized feedback, continuous monitoring, and easier tracking of progress. This integrated approach is crucial for obesity patients as it provides a structured, accessible, and engaging way to adhere to weight loss programs, thereby improving the likelihood of successful outcomes.

Interventions to Treat Obesity in Mexican Children and Adolescents: Systematic Review and Meta-Analysis.