The GLOW Study
The Colony, Texas, 75056, United States
Location contact
Rakesh Jain, MD, MPH
PRINCIPAL_INVESTIGATOR
Saundra Jain, MA, PsyD, LPC
CONTACT
Saundra Jain, MA, PsyD, LPC
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07760896
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The Colony, Texas, 75056, United States
Rakesh Jain, MD, MPH
PRINCIPAL_INVESTIGATOR
Saundra Jain, MA, PsyD, LPC
CONTACT
Saundra Jain, MA, PsyD, LPC
PRINCIPAL_INVESTIGATOR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age 18 years or older. Able to speak, read, and understand English. Interested in supporting physical and emotional well-being. Access to a reliable Internet-enabled device, such as a computer, smartphone, or tablet.
Possess basic skills needed to complete online study forms. Currently prescribed and taking a GLP-1 receptor agonist or dual GIP/GLP-1 receptor agonist by a licensed healthcare practitioner.
Report that the medication was prescribed for an FDA-approved indication, such as type 2 diabetes mellitus, chronic weight management for obesity or overweight with at least one weight-related condition, moderate-to-severe obstructive sleep apnea in adults with obesity, or another FDA-approved cardiometabolic indication.
Willing to complete online consent, registration, program measures, and daily tracking forms.
Willing to participate in the 30-day WILD 5 Wellness program delivered as part of the GLOW Study.
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Exclusion criteria
Under 18 years of age. Unable to speak, read, or understand English. Do not have access to a reliable Internet-enabled device. Do not possess basic skills needed to complete online study forms. Not currently prescribed and taking a GLP-1 receptor agonist or dual GIP/GLP-1 receptor agonist by a licensed healthcare practitioner.
Report that the medication was not prescribed for an FDA-approved indication. Pregnant or planning to become pregnant in the next 30 days. Currently have thoughts about harming themselves or someone else. Currently experiencing symptoms suggestive of active psychosis. Unwilling or unable to complete the required online study forms or participate in the 30-day
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A 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.
Time frame: Baseline and end of 30-day intervention
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 intervention
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 intervention
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 intervention
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 intervention
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 intervention
The Eating and Appraisal Due to Emotions and Stress (EADES) scale is a self-report measure of emotion- and stress-related eating. Total scores range from 24 to 120, with lower scores indicating greater emotion- and stress-related eating. 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 intervention
The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure of mindfulness and attention to present-moment experiences. Total scores range from 15 to 90, with higher scores indicating greater mindfulness. 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 intervention
The Sleep Condition Indicator (SCI) is an 8-item self-report measure of sleep problems. Total scores range from 0 to 32, with lower scores indicating greater sleep problems. 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 intervention
The Social Connectedness Scale is a self-report measure of perceived social connectedness. Total scores range from 8 to 48, with higher scores indicating greater social connectedness. 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 intervention
The World Health Organization-5 Well-Being Index (WHO-5) is a 5-item self-report measure of subjective well-being. Total scores range from 0 to 25, with higher scores indicating greater well-being. 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 intervention
The Sheehan Disability Scale (SDS) is a self-report measure of functional impairment in work or school, social life, and family life. Each domain is rated from 0 to 10, with higher scores indicating greater functional impairment. The outcome will be the change in SDS scores from pre-program baseline to post-program assessment.
Time frame: End of 30-day intervention
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 intervention
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.
Contact information is provided by the study sponsor or research team.
Saundra Jain
Other
Acronym: GLOW
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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