The GLOW Study: GLP-1 and Lifestyle for Optimal Wellness
ConditionWellness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaundra Jain
About this trial
The goal of this clinical trial is to learn whether a 30-day structured wellness program may support physical and emotional well-being in adults who are already taking a GLP-1 or dual GIP/GLP-1 medication for an FDA-approved indication. The study does not evaluate the GLP-1 medication itself or make changes to participants' medication treatment.
The main questions it aims to answer are:
1. Are there changes in participants' physical and emotional well-being after completing the 30-day wellness program? 2. Are there changes in areas such as mood, anxiety, functioning, mindfulness, self-compassion, eating-related behaviors, pain, and positive wellness?
Participants will:
1. Complete online questionnaires before and after the program. 2. Follow the WILD 5 Wellness program for 30 days, which includes daily practices related to exercise, mindfulness, sleep, social connection, and nutrition. 3. Complete a brief online tracking form each day during the 30-day program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
WILD 5 Wellness Program
BehavioralA 30-day structured wellness program that includes daily practices in five areas: exercise, mindfulness, sleep, social connection, and nutrition. Participants complete the wellness practices independently and complete daily online tracking during the 30-day program.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: WILD 5 Wellness ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in HERO Wellness Scale Total Score From Baseline to Post-Program
The HERO Wellness Scale is a 5-item self-report measure assessing happiness, enthusiasm, resilience, optimism, and perceived mental wellness. Total scores range from 0 to 50, with higher scores indicating greater mental wellness. The outcome will be the change in total score from pre-program baseline to post-program assessment.
Time frame
Baseline and end of 30-day interventionSecondary outcomes
1
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score From Baseline to Post-Program
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptom severity. Total scores range from 0 to 27, with lower scores indicating fewer depressive symptoms. The outcome will be the change in total score from pre-program baseline to post-program assessment.
Time frame
Baseline and end of 30-day intervention2
Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score From Baseline to Post-Program
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptoms. Total scores range from 0 to 21, with lower scores indicating fewer anxiety symptoms. The outcome will be the change in total score from pre-program baseline to post-program assessment.
Time frame
Baseline and end of 30-day intervention3
Change in Brief Pain Inventory Average Pain Score From Baseline to Post-Program
The Brief Pain Inventory Average Pain item is a self-report measure of pain severity. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as the participant can imagine. The outcome will be the change in score from pre-program baseline to post-program assessment.
Time frame
Baseline and end of 30-day intervention4
Change in Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score From Baseline to Post-Program
The Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item self-report measure of cognitive and physical functioning. Total scores range from 7 to 42, with lower scores indicating better cognitive and physical functioning. The outcome will be the change in total score from pre-program baseline to post-program assessment.
Time frame
Baseline and end of 30-day interventionOther outcomes
1
Participant-Reported Change in Selected Substance-Use Behaviors
The GLP-1 Change Questionnaire is a project-specific post-program questionnaire assessing participant-reported change since the beginning of the GLOW Study in selected substance-use-related behaviors, including alcohol use, cigarette smoking, cannabis or marijuana use, benzodiazepine use, and opiate or opioid use. Response options range from "Very much improved" to "Very much worse," with an additional "This question does not apply to me" option. The questionnaire is exploratory and is not a diagnostic tool.
Time frame
End of 30-day intervention2
Post-Program Participant Questionnaire
A project-specific questionnaire completed at the end of the 30-day intervention to collect participant-reported information about the GLOW Study experience and post-program responses. The questionnaire also includes an item asking whether the participant would like to view and download an Individual Summary Report summarizing pre- and post-program scores.
Time frame
End of 30-day interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Saundra Jain
Lead sponsor
University of Texas at Austin
Sponsor institution
Source ClinicalTrials.gov