What side effects are associated with this type of intervention?

Common treatments for weight loss include mobile app-based interventions, pharmacological treatments, and lifestyle modifications. Mobile app-based interventions, such as Noom Health, generally have minimal side effects, primarily involving user engagement and adherence challenges. Pharmacological treatments, like phentermine and other appetite suppressants, can cause side effects such as increased heart rate, elevated blood pressure, insomnia, and dry mouth. Lifestyle modifications, including diet and exercise, are generally safe but may lead to temporary discomforts like muscle soreness or fatigue.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for weight loss, including semaglutide (brand name: Wegovy) and liraglutide (brand name: Saxenda). These medications have shown efficacy in clinical trials for weight reduction. Additionally, mobile app-based interventions like Noom Health are being studied for their effectiveness in weight loss and maintenance. These digital health tools provide support and behavioral interventions, complementing pharmacological treatments by promoting lifestyle changes and self-monitoring.

What other types of research exist?

Promising alternatives to Noom Health for weight loss patients in 2024 include: 1) Mobile apps with real-time monitoring and notifications, such as those studied for smoking cessation, which could be adapted for weight loss. 2) Digital platforms like SmokeFree.gov, which have shown increased engagement during the COVID-19 pandemic and could be repurposed for weight management. 3) Smartphone apps delivering cognitive-behavioral therapy (CBT) for eating disorders, which have demonstrated efficacy in randomized controlled trials. 4) Integrative approaches combining nutritional, psychological, and pharmacological treatments, as seen in studies for binge-eating disorder. These alternatives leverage technology and evidence-based interventions to support weight loss and maintenance.

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Noom Health for Weight Loss

N/A

Waitlist Available

Led By Thomas Hildebrandt, PsyD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Ages of 18 and 60 at entry to the study

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses the Noom mobile app to help people lose weight, focusing on older individuals with more health issues. It compares a full-featured version with coach support to a simpler version to see which is more effective. Noom is a mobile app that provides various lifestyle-related logs including food logging, exercise logging, and weight logging.

Who is the study for?

This trial is for adults aged 18-60 with a BMI over 27 who want to manage their weight using the Noom app. They must speak English and not be current Noom users, pregnant, at risk of suicide, or have health issues related to smartphone use.

What is being tested?

The study compares two versions of the Noom program: 'Noom Health' and 'Noom Digital Health'. It will assess which is better for weight loss, quality of life, psychosocial functioning, and self-reported health status after intervention and in maintaining long-term weight loss.

What are the potential side effects?

Since this trial involves digital health programs rather than medications or medical procedures, traditional side effects are not expected. However, participants may experience psychological impacts or stress related to lifestyle changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 30 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

Change in Weight from Baseline to 30 Months

Change in Weight from Baseline to 6 Months

Secondary study objectives

12-Month Completion Status

Adherence to intervention measured using a percentage of the total number of available app features used from Baseline to 6 Months

Anxiety

+12 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: Noom HealthExperimental Treatment1 Intervention

Group II: Noom Digital HealthActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Noom Health

2021

N/A

~600

0 / 1Eligibility 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

Mobile app-based weight loss interventions, such as Noom Health, leverage behavioral modification techniques, dietary guidance, physical activity tracking, and psychological support to promote weight loss. These apps often use cognitive-behavioral strategies to help users identify and change unhealthy eating patterns, set realistic goals, and maintain motivation. By providing real-time feedback and personalized coaching, these interventions can enhance adherence to weight loss plans. This matters for weight loss patients as it offers a structured, accessible, and supportive approach to achieving and maintaining a healthier weight.

Monday-focused tailored rapid interactive mobile messaging for weight management 2 (MTRIMM2): results from a randomized controlled trial.Examining the efficacy of a multicomponent m-Health physical activity, diet and sleep intervention for weight loss in overweight and obese adults: randomised controlled trial protocol.A text messaging-assisted randomized lifestyle weight loss clinical trial among overweight adults in Beijing.