Lifestyle Change Implementation Research Network at PRC at UMass Chan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Lifestyle Coaching Program.
- Who it may be relevant to
- Registry conditions: GLP - 1. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this project is to study how well the Noom digital lifestyle program works for adults who are taking Glucagon-Like Peptide-1 receptor agonist (GLP-1) medications. The study team will assess how the program affects people's behaviors and health outcomes. The team will also look at how digital lifestyle change interventions can be implemented in real-world settings, including how many people it reaches, how well it is put into practice, whether people stick with it over time, and whether it works well for different groups of people.
Detailed description
This study will examine how a digital lifestyle change program (Noom) may support adults who have recently started taking GLP-1 medications, which are commonly prescribed for weight loss and blood sugar control. The goal is to better understand how structured lifestyle guidance may improve physical activity, nutrition, and overall health while people are using these medications.
A total of 220 adults will participate in the study. Participants will be randomly assigned to one of two groups. One group will receive a four-month digital lifestyle coaching program designed to support healthy eating, physical activity, and strength-building habits. The other group will receive standard of care, a Fitbit device, resources for physical activity and nutrition, and the opportunity to participate in the lifestyle program at the completion of their 8-months in the study.
Participants will be assessed at the start of the study, after four months, and again at eight months. Throughout the study, the team will measure levels of physical activity using Fitbit devices. They will also evaluate overall diet quality using 24- hour dietary recalls of foods and beverages consumed. In addition, the team will examine other health and behavior measures, including intake of protein, fruits, and vegetables; participation in muscle-strengthening activities; confidence in maintaining healthy habits; muscle mass; body weight; waist circumference; and blood pressure.
In the 2nd Aim, the study team will evaluate implementation factors, such as how many participants were reached, how the program was implemented, engagement within the program, and how well how well the lifestyle coaching program can be delivered within real-world healthcare settings. Information will be gathered from patients, lifestyle change program leaders, healthcare providers, and healthcare systems. Data sources will include medical records, program records, and interviews.
Interventions
- Other Digital Lifestyle Coaching Program
Participants will be enrolled for a 4-month program, in which they will use the Noom app to self-monitor their dietary intake/physical activity, be provided with coaching feedback throughout, and access educational module. Modules include behavior change specific to GLP-1, i.e. higher protein intake than what is prescribed in Noom Weight, Common challenges while taking GLP-1 medications, and weight loss medications and what to expect while taking them. They will also have access to the Muscle De
Primary outcome measures
- Primary Outcomes [Time frame: Baseline, 4-, and 8-months]
- Healthy Eating Index [Time frame: Baseline, 4, and 8 months]
Secondary outcome measures (12)
- Physical Activity/Sedentary Time Metrics [Time frame: Mean counts over 7-days at baseline, 4-, and 8-months.]
- Protein, Fruit, and Vegetable Intake [Time frame: Baseline, 4-, and 8-months]
- Lean Body Mass [Time frame: Baseline, 4-, and 8-months]
- Body Weight [Time frame: Baseline, 4-, and 8-months]
- Blood Pressure [Time frame: Baseline, 4-, and 8-months]
- Body Mass Index (BMI) [Time frame: Baseline, 4-, and 8-months]
- Muscle Strengthening Activities [Time frame: Baseline, 4-, and 8-months]
- Physical Activity Self-Efficacy [Time frame: Baseline, 4-, and 8-months]
- Physical Activity Motivation [Time frame: Baseline, 4-, and 8-months]
- Healthy Eating Self-Efficacy [Time frame: Baseline, 4-, and 8-months]
- Healthy Eating Motivation [Time frame: Baseline, 4-, and 8-months]
- Global Physical Health [Time frame: Baseline, 4-, and 8-months]
Eligibility criteria
Inclusion criteria
- Began using a GLP-1 within the past 6 months
- Currently using GLP-1
- Plans to continue GLP-1 use
- GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)
- BMI ≥27 kg/m2
- Age 18 years of age and older
- Speaks and reads English or Spanish
- Willing to enroll in a digital lifestyle intervention for 4-months
- Willing to wear a Fitbit for 8 months
Exclusion criteria
- Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
- Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
- Currently pregnant
- Planning to become pregnant in the next year
- Active diagnosis of an eating disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UMass Chan Medical School - Shaw Building — Worcester
Identifiers
NCT: NCT07481305 · STUDY00002809 · U48DP006955