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Lifestyle Change Implementation Research Network bij PRC bij UMass Chan (LCIRN)

21 september 2026 bijgewerkt door: Jamie Faro, University of Massachusetts, Worcester

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

220

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Worcester, Massachusetts, Verenigde Staten, 01605
        • Werving
        • UMass Chan Medical School - Shaw Building
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Began using a GLP-1 within the past 6 months
  2. Currently using GLP-1
  3. Plans to continue GLP-1 use
  4. GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)
  5. BMI ≥27 kg/m2
  6. Age 18 years of age and older
  7. Speaks and reads English or Spanish
  8. Willing to enroll in a digital lifestyle intervention for 4-months
  9. Willing to wear a Fitbit for 8 months

Exclusion Criteria:

  1. Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
  2. Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
  3. Currently pregnant
  4. Planning to become pregnant in the next year
  5. Active diagnosis of an eating disorder
  6. Active diagnosis of Schizophrenia or bipolar disorder
  7. Unable to walk without assistance/assistive device or have restricted walking
  8. Inability to understand the study and provide informed consent
  9. Any physical, cognitive, or psychiatric condition that poses a risk or interferes with their ability to participate at the discretion of the study PI (Co-Is: in consultation with PI or if acting as/standing in for PI)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Digital Lifestyle Coaching Program

Participants randomized to the digital LCI arm will participate in a 4-month digital lifestyle intervention consisting of content modules about physical activity, nutrition, and GLP-1 support, nutrition and physical activity tracking, goal-setting, access to a health coach. They will receive a Fitbit and the same resources as the Standard of Care arm.
Ander: 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 Defense program, which provides education on resistance training exercises to prevent muscle loss.
Geen tussenkomst: Standard Care

Participants in the standard of care arm will receive physical activity and nutrition resources, including those endorsed by the CDC and local resources within UMass Memorial Health and the surrounding communities, as well as Fitbit device. Upon completion of the 8-month study measures, participants will have the opportunity to participate in the 4-month digital LCI program, free of cost.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Primary Outcomes
Tijdsspanne: Baseline, 4-, and 8-months

Minutes of moderate/vigorous PA per day (over 7 days) assessed via Fitbits on days the participant has sufficient wear time, defined as >10 hours of heart rate data (accumulated of 60-second bouts).
Baseline, 4-, and 8-months
Healthy Eating Index
Tijdsspanne: Baseline, 4, and 8 months

Healthy Eating Index will be assessed via two 24-hour dietary recalls at each timepoint. The Healthy Eating Index is scored on a scale 0-100, with higher scores indicating better diet quality and alignment with the Dietary Guidelines for Americans.
Baseline, 4, and 8 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical Activity/Sedentary Time Metrics
Tijdsspanne: Mean counts over 7-days at baseline, 4-, and 8-months.

Objective metrics of mean step counts (steps/day), light physical activity (minutes/day), sedentary time (hours/day) over 7 days assessed via Fitbit Inspire using Fitbit algorithms and obtained through Fitabase.
Mean counts over 7-days at baseline, 4-, and 8-months.
Protein, Fruit, and Vegetable Intake
Tijdsspanne: Baseline, 4-, and 8-months

Proportion of daily intake values for each category will be assessed using two 24-hour dietary recalls.
Baseline, 4-, and 8-months
Lean Body Mass
Tijdsspanne: Baseline, 4-, and 8-months

Lean body mass will be assessed using a seca mBCA 554 bioelectrical impedance scale. The scale will obtain the results of the patient's body composition (% muscle mass, % water, % body fat, including areas of distribution).
Baseline, 4-, and 8-months
Body Weight
Tijdsspanne: Baseline, 4-, and 8-months

Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.
Baseline, 4-, and 8-months
Blood Pressure
Tijdsspanne: Baseline, 4-, and 8-months

Three blood pressure readings will be taken 2 minutes apart after 5 minutes of rest using an automatic oscillometric device, Omron HEM-907. The average of the three readings will be recorded.
Baseline, 4-, and 8-months
Body Mass Index (BMI)
Tijdsspanne: Baseline, 4-, and 8-months

Obtained via two height measurements using a stadiometer and one weight measurement using a Seca scale, using the standard equation (Weight (lbs) x 703) / height (in)2
Baseline, 4-, and 8-months
Muscle Strengthening Activities
Tijdsspanne: Baseline, 4-, and 8-months

Assessed via self-report using the Muscle Strengthening Exercise Questionnaire Short Form, a scale assessing key dimensions of muscle-strengthening exercise, including frequency, session duration, intensity, exercise type, and muscle groups targeted
Baseline, 4-, and 8-months
Physical Activity Self-Efficacy
Tijdsspanne: Baseline, 4-, and 8-months

A self-report assessment using the Self-efficacy for Physical Activity Scale, a 5-question scale assessing how confident a person is that they could be physically active in certain situations
Baseline, 4-, and 8-months
Physical Activity Motivation
Tijdsspanne: Baseline, 4-, and 8-months

A self-report assessment using the 1 question Readiness to Change for Physical Activity, which assess a person's current physical activity habits and readiness to change.
Baseline, 4-, and 8-months
Healthy Eating Self-Efficacy
Tijdsspanne: Baseline, 4-, and 8-months

A self-report assessment using the Eating and Weight Self-efficacy Scale, a 7-question scale assessing a person's confidence to eat healthy in certain situations
Baseline, 4-, and 8-months
Healthy Eating Motivation
Tijdsspanne: Baseline, 4-, and 8-months

A self-report assessment using the 1 question Readiness to Change for Healthy Eating, which assess a person's current eating habits and readiness to change
Baseline, 4-, and 8-months
Global Physical Health
Tijdsspanne: Baseline, 4-, and 8-months

Physical health will be assessed using the PROMIS Global Physical Health, consisting of 4 questions asking about overall health, physical function, pain, and fatigue using Likert scale responses
Baseline, 4-, and 8-months
Intervention Acceptability
Tijdsspanne: 4-months in Intervention group only

The Theoretical Framework of Acceptability (TFA) is an 8-item questionnaire that can be adapted to an intervention to assess the acceptability of healthcare interventions using a Likert scale of 1 to 5 (higher scores indicating greater acceptability).
4-months in Intervention group only

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Massachusetts, Worcester

Medewerkers

Centers for Disease Control and Prevention
University of Massachusetts, Lowell

Onderzoekers

  • Hoofdonderzoeker: Jamie Faro, PhD, UMass Chan Medical School

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 juli 2026

Primaire voltooiing (Geschat)

30 april 2029

Studie voltooiing (Geschat)

29 september 2029

Studieregistratiedata

Eerst ingediend

13 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 maart 2026

Eerst geplaatst (Werkelijk)

18 maart 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00002809
  • U48DP006955 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Participant survey data and participant physiologic data will be shared. This includes a complete, de-identified data set, including survey and clinical/physiologic data (and relevant R or SAS code) through DKnet, the Inter-University Consortium for Political and Social Research, or eScholarship@UMassChan.

IPD-tijdsbestek voor delen

IPD and supporting information will become available at time of primary results publication.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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