Lifestyle Change Implementation Research Network at PRC at UMass Chan
ConditionGLP - 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Lifestyle Coaching Program
Other interventionParticipants 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Digital Lifestyle Coaching ProgramExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Outcomes
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).
Time frame
Baseline, 4-, and 8-months2
Healthy Eating Index
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.
Time frame
Baseline, 4, and 8 monthsSecondary outcomes
1
Physical Activity/Sedentary Time Metrics
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.
Time frame
Mean counts over 7-days at baseline, 4-, and 8-months.2
Protein, Fruit, and Vegetable Intake
Proportion of daily intake values for each category will be assessed using two 24-hour dietary recalls.
Time frame
Baseline, 4-, and 8-months3
Lean Body Mass
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).
Time frame
Baseline, 4-, and 8-months4
Body Weight
Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.
Time frame
Baseline, 4-, and 8-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
University of Massachusetts, Lowell
Collaborator
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov