What side effects are associated with this type of intervention?

Common treatments for obesity include pharmacologic therapies such as semaglutide and liraglutide, and lifestyle interventions like diet and exercise programs. Semaglutide and liraglutide, both GLP-1 receptor agonists, are associated with gastrointestinal side effects, including nausea and vomiting. These medications also require subcutaneous injections, which may be a barrier for some patients. Lifestyle interventions, while generally safe, can sometimes lead to musculoskeletal injuries or nutritional deficiencies if not properly managed. Overall, the side effects of these treatments are generally manageable and should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications are often used in conjunction with lifestyle interventions such as diet and exercise. Orlistat works by inhibiting fat absorption, while phentermine-topiramate and naltrexone-bupropion act on the central nervous system to reduce appetite. Liraglutide, a GLP-1 receptor agonist, helps regulate appetite and calorie intake. These treatments are typically part of comprehensive weight management programs that may include self-help tools to increase patient engagement, similar to the EMBER trial's focus on enhancing participation in weight management programs.

What other types of research exist?

Promising alternatives to EMBER for obesity patients include: 1) Bariatric Embolization, a new endovascular procedure shown to be safe and effective in reducing weight over 12 months. 2) Digital self-help interventions, such as internet-based guided self-help and smartphone applications like Noom Monitor, which have demonstrated efficacy in reducing binge eating and supporting weight management. 3) Cognitive Behavioral Therapy (CBT) guided self-help programs, which focus on developing regular eating patterns and self-control techniques.

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EMBER Self-Help Tool for Obesity Management

N/A

Waitlist Available

Led By Jessica Yelena Breland, PhD MS BA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Self-report from potential participant they plan to leave VA Palo Alto or Houston within the next 6 months

Hospitalization in the past 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2- and 6-months post randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether EMBER, a motivational self-help tool, helps veterans with obesity engage in VHA weight management programs. Veterans will either use EMBER or be informed about available programs. The study will measure if those using EMBER are more likely to join and stick with these programs.

Who is the study for?

The EMBER Trial is for veterans with obesity (BMI ≥ 30 kg/m2) who have used VA Palo Alto or Houston primary care in the past year. It's not for those over 80, under 18, anyone hospitalized recently, with cognitive issues, a recent suicide attempt, or who've used VA weight management programs in the last two years.

What is being tested?

This trial tests if EMBER—a self-help tool—increases engagement in VHA weight management programs compared to a control group receiving a list of these programs. Participants are randomly assigned to either group and will provide health information at various intervals via phone.

What are the potential side effects?

Since EMBER is a self-help tool designed to encourage participation in weight management programs rather than a medical treatment or drug intervention, it does not have physical side effects like medications do.

Eligibility Criteria

Exclusion Criteria

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

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I plan to leave VA Palo Alto or Houston in the next 6 months.

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I have been hospitalized within the last 30 days.

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I am under 18 years old.

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I am 80 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2- and 6-months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2- and 6-months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2- and 6-months post randomization for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

New weight management behavior

Number of weight management visits

Physical Activity

+3 more

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: EMBERExperimental Treatment1 Intervention

Self-help tool to increase weight management engagement

Group II: ControlActive Control1 Intervention

List of treatments

0 / 4Eligibility 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 include pharmacologic therapy, lifestyle interventions, and behavioral support. Pharmacologic treatments, such as GLP-1 receptor agonists (e.g., liraglutide and semaglutide), work by enhancing satiety and reducing appetite, leading to decreased caloric intake. Lifestyle interventions focus on dietary changes and increased physical activity to promote weight loss and improve metabolic health. Behavioral support, including self-help tools like EMBER, aims to increase patient engagement and adherence to weight management programs by addressing psychological and motivational factors. These mechanisms are crucial for obesity patients as they provide a comprehensive approach to weight loss, addressing both physiological and behavioral aspects, thereby improving the likelihood of long-term success.