CClinicalTrials.gg
RecruitingNCT07760896GLOWUpdated Sep 3, 2026

The GLOW Study: GLP-1 and Lifestyle for Optimal Wellness

An interventional study of WILD 5 Wellness Program in Wellness, sponsored by Saundra Jain. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Saundra Jain · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Wellness

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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

-

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    WILD 5 Wellness Program

    Participants will complete the 30-day WILD 5 Wellness program, which includes daily practices related to exercise, mindfulness, sleep, social connection, and nutrition.

    Behavioral: WILD 5 Wellness 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.

05

What researchers measure

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 intervention

Secondary 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 intervention

  2. 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 intervention

  3. 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 intervention

  4. 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 intervention

  5. Change in Eating and Appraisal Due to Emotions and Stress (EADES) Total Score From Baseline to Post-Program

    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

  6. Change in Mindful Attention Awareness Scale (MAAS) Total Score From Baseline to Post-Program

    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

  7. Change in Sleep Condition Indicator (SCI) Total Score From Baseline to Post-Program

    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

  8. Change in Social Connectedness Scale Total Score From Baseline to Post-Program

    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

  9. Change in World Health Organization-5 Well-Being Index (WHO-5) Total Score From Baseline to Post-Program

    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

  10. Change in Sheehan Disability Scale (SDS) Scores From Baseline to Post-Program

    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: Baseline and end of 30-day intervention

Other 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 intervention

  2. 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 intervention

06

Study locations

1 of 1 sites recruiting
  • The GLOW Study
    The Colony, Texas 75056, United States
    • Saundra Jain, MA, PsyD, LPC · Contact · saundrajain@gmail.com · 888-252-7806
    • · Contact · saundrajain@gmail.com
    • Saundra Jain, MA, PsyD, LPC · Principal investigator
    • Rakesh Jain, MD, MPH · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared outside the study team unless required by law or regulation or approved by the Institutional Review Board. Study findings may be presented or published only in aggregate or de-identified form.

08

Registry details

Key details

Study ID
NCT07760896
Lead sponsor
Saundra Jain
Responsible party
Saundra Jain (Adjunct Clinical Affiliate, University of Texas at Austin) — Sponsor-investigator
First posted
Aug 12, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Saundra Jain, MA, PsyD, LPC
Contact
saundrajain@gmail.com
888-252-7806
Saundra Jain, MA, PsyD, LPC
principal investigator · The University of Texas at Austin School of Nursing
Rakesh Jain, MD, MPH
principal investigator · Texas Tech University Health Sciences Center School of Medicine - Permian Basin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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