220 Participants NeededMy employer runs this trial

Digital Lifestyle Coaching for Obesity

(LCIRN Trial)

Recruiting at 1 trial location
RY
JW
Overseen ByJoann Wagner, MSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
Must be taking: GLP-1
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 how well the Noom digital lifestyle program aids individuals using GLP-1 medications (a type of drug that manages obesity) in improving their health and habits. Participants receive digital coaching on physical activity, nutrition, and support for medication use. The trial compares this program to standard care, which includes general resources and a Fitbit device. Individuals who have started taking GLP-1 medication in the last six months, have a BMI of 27 or higher, and are willing to join a 4-month digital program and wear a Fitbit for 8 months might be a good fit. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle interventions alongside current treatment.

Will I have to stop taking my current medications?

You will not have to stop taking your current medications. In fact, the trial requires that you continue using your GLP-1 medication as prescribed by your doctor.

What prior data suggests that this digital lifestyle coaching program is safe?

Earlier studies have shown that digital lifestyle coaching programs can effectively help people manage their weight. Research indicates that these programs are generally user-friendly. For instance, one study on a similar digital health coaching program found that participants experienced positive health outcomes without major side effects. This suggests that digital lifestyle programs are safe for most people. Although specific data on side effects from these programs wasn't highlighted, the absence of reported safety concerns in these studies is reassuring.12345

Why are researchers excited about this trial?

Researchers are excited about the Digital Lifestyle Coaching Program for obesity because it integrates technology and personalized support to tackle lifestyle changes. Unlike traditional methods that might focus solely on diet and exercise, this program offers a comprehensive digital intervention that includes physical activity and nutrition modules, goal-setting, and guidance from a health coach. Plus, participants receive a Fitbit to track their progress in real-time. This blend of technology and personal coaching has the potential to provide more tailored and engaging support, which could lead to better outcomes in managing obesity.

What evidence suggests that the Digital Lifestyle Coaching Program is effective for obesity?

This trial will compare a Digital Lifestyle Coaching Program with Standard Care for managing obesity. Studies have shown that digital lifestyle coaching can effectively help people lose weight. For example, some digital programs, including health coaching, have produced weight loss results similar to those of in-person programs. Research indicates that digital tools like apps and online platforms simplify tracking food intake and exercise, aiding weight management. Additionally, combining digital coaching with self-monitoring tools has improved weight loss and overall health outcomes. These findings suggest that digital lifestyle coaching could be a promising option for managing obesity.13678

Who Is on the Research Team?

JF

Jamie Faro, PhD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have started a GLP-1 medication in the past 6 months, are currently using it as prescribed by their doctor, have a BMI of 27 or higher, speak English or Spanish, and are willing to join a digital lifestyle program for 4 months and wear a Fitbit for 8 months.

Inclusion Criteria

I am 18 years old or older.
I started using a GLP-1 medication within the last 6 months.
I am currently taking a GLP-1 medication.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-month digital lifestyle coaching program or standard care with resources and a Fitbit device

16 weeks
Baseline, 4-month, and 8-month assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical activity, diet quality, and other health measures

8 weeks
8-month assessment

Open-label extension (optional)

Participants in the standard care group have the opportunity to participate in the 4-month digital lifestyle coaching program after completing the initial 8-month study

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Lifestyle Coaching Program

Trial Overview

The study tests how effective the Noom digital lifestyle coaching program is at improving health habits and outcomes in people taking GLP-1 medications. It also looks at how well this type of online support can be used in real-world settings.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Digital Lifestyle Coaching ProgramExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

University of Massachusetts, Lowell

Collaborator

Trials
21
Recruited
10,300+

Centers for Disease Control and Prevention

Collaborator

Trials
902
Recruited
25,020,000+

Citations

Evaluating the Impact of a Virtual Health Coaching Lifestyle ...

This study suggests post-operative virtual health coaching can enhance weight loss outcomes after sleeve gastrectomy.

Efficacy of in-person versus digital enhanced lifestyle ... - PMC

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NCT03529903 | MyLife: A Digital Health Coaching Program

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This study aims to examine the effectiveness of combining self-monitoring apps with health coaching on anthropometric, cardiometabolic, and lifestyle outcomes

Real-world outcomes of hybrid obesity care using digital ...

We evaluated real-world outcomes among 708 adults enrolled in NOVI Optimum Plus, a physician-led obesity program in Singapore that integrates ...

An AI-Powered Lifestyle Intervention vs Human Coaching in ...

ARTICLE: An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial.

Effects of Stand-Alone Digital Lifestyle Interventions on ...

This systematic review and meta-analysis provides several critical implications for the field of digital health and obesity management.