What side effects are associated with this type of intervention?

Behavioral modification programs for obesity, such as those delivered via apps, generally have minimal side effects. Participants may experience initial challenges such as increased hunger, fatigue, or muscle soreness due to changes in diet and increased physical activity. However, these side effects are usually temporary and can be managed with proper guidance. In contrast, pharmacotherapy for obesity, such as semaglutide or liraglutide, can cause gastrointestinal side effects like nausea, vomiting, and diarrhea. It's important for patients to discuss potential side effects with their healthcare provider to choose the most suitable treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including liraglutide and semaglutide, which are GLP-1 receptor agonists administered via subcutaneous injection. These drugs have shown efficacy in weight reduction and improvement in glycemia and lipids. Other approved medications include orlistat, which reduces fat absorption, and combination drugs like phentermine-topiramate and bupropion-naltrexone, which act on the central nervous system to suppress appetite. While these pharmacologic treatments are effective, they are often recommended in conjunction with lifestyle interventions, such as behavioral modification programs, to enhance weight loss outcomes.

What other types of research exist?

Promising alternatives to behavioral modification via app for obesity treatment in 2024 include: 1) Digital health programs modeled after the diabetes prevention program, which have shown effectiveness in reducing weight and improving health metrics. 2) Cognitive-behavioral therapy (CBT), particularly when modified for specific populations, has demonstrated efficacy in weight management and improving quality of life. 3) Multidisciplinary in-clinic interventions that combine various healthcare professionals to provide comprehensive weight management support.

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WW App-Based Program for Obesity (WINS Trial)

N/A

Waitlist Available

Led By Ana M Palacios, MD, PhD

Research Sponsored by Georgia Southern University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6-months

Summary

This trial tests if a weight loss and wellness app can improve diet quality in U.S. adults over several months. The app offers personalized advice, tracks food and activities, and provides support from coaches and peers.

Who is the study for?

This trial is for U.S. adults aged 18-70 with a BMI of 27-45 who want to lose weight and are willing to use an app-based wellness program for 6 months. Participants must have Wi-Fi, a smartphone, and be English-speaking. Excluded are those with severe depression, recent major surgery or bariatric surgery, untreated thyroid disease, certain heart problems or cancers, psychiatric hospitalization within the past year, pregnancy or nicotine use.

What is being tested?

The study tests if a mobile app-based weight management program (WW) can improve diet quality over six months compared to a control group without this intervention. The participants will be randomly assigned to either the WW program or control group.

What are the potential side effects?

Since this is not a drug trial but rather an intervention using an app for behavior change in diet and exercise, there may not be direct side effects like medications; however participants might experience discomfort adjusting their lifestyle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6-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

Diet quality (Healthy Eating Index - 2015 score)

Secondary study objectives

Achievement of 10% weight loss

Achievement of 3% weight loss

Achievement of 5% weight loss

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Access to WW app for 6 monthsExperimental Treatment1 Intervention

Participants will be randomized to access the WW application for 6 months

Group II: ControlPlacebo Group1 Intervention

Participants will be randomized to receive emails with information available from myplate.gov

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2020

N/A

~360

Do I qualify?Apply below to find out

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 behavioral modification, pharmacotherapy, and dietary therapy. Behavioral modification, such as the WW Improving Nutrition Study, uses apps or programs to promote healthy eating, physical activity, and self-monitoring. Pharmacotherapy involves medications that reduce appetite or increase satiety, while dietary therapy includes structured eating plans to reduce caloric intake. These treatments are crucial for obesity patients as they address the underlying causes of obesity and offer sustainable strategies for weight loss and overall health improvement.

A pilot open-label feasibility trial examining an adjunctive mindfulness intervention for adolescents with obesity.