Wellness
Conditions
Keywords
GLP-1, GLP-1 Receptor Agonist, GIP/GLP-1 Receptor Agonist, Lifestyle Intervention, WILD 5 Wellness, Physical Well-Being, Emotional Well-Being, Self-Management
Brief summary
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.
Interventions
BEHAVIORALWILD 5 Wellness Program
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.
Sponsors
Saundra Jain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HERO Wellness Scale Total Score From Baseline to Post-Program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) Total Score From Baseline to Post-Program | 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. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score From Baseline to Post-Program | 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. |
| Change in Brief Pain Inventory Average Pain Score From Baseline to Post-Program | 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. |
| Change in Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score From Baseline to Post-Program | 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. |
| Change in Eating and Appraisal Due to Emotions and Stress (EADES) Total Score From Baseline to Post-Program | 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. |
| Change in Mindful Attention Awareness Scale (MAAS) Total Score From Baseline to Post-Program | 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. |
| Change in Sleep Condition Indicator (SCI) Total Score From Baseline to Post-Program | 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. |
| Change in Social Connectedness Scale Total Score From Baseline to Post-Program | 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. |
| Change in World Health Organization-5 Well-Being Index (WHO-5) Total Score From Baseline to Post-Program | 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. |
| Change in Sheehan Disability Scale (SDS) Scores From Baseline to Post-Program | 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. |
Countries
United States
Contacts
CONTACTSaundra Jain, MA, PsyD, LPC
PRINCIPAL_INVESTIGATORSaundra Jain, MA, PsyD, LPC
The University of Texas at Austin School of Nursing
PRINCIPAL_INVESTIGATORRakesh Jain, MD, MPH
Texas Tech University Health Sciences Center School of Medicine - Permian Basin
Outcome results
None listed