NCT07760896

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. 1.Are there changes in participants' physical and emotional well-being after completing the 30-day wellness program?
  2. 2.Are there changes in areas such as mood, anxiety, functioning, mindfulness, self-compassion, eating-related behaviors, pain, and positive wellness?
  3. 3.Complete online questionnaires before and after the program.
  4. 4.Follow the WILD 5 Wellness program for 30 days, which includes daily practices related to exercise, mindfulness, sleep, social connection, and nutrition.
  5. 5.Complete a brief online tracking form each day during the 30-day program.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

GLP-1GLP-1 Receptor AgonistGIP/GLP-1 Receptor AgonistLifestyle InterventionWILD 5 WellnessPhysical Well-BeingEmotional Well-BeingSelf-Management

Outcome Measures

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.

    Baseline and end of 30-day intervention

Secondary Outcomes (10)

  • Change in Patient Health Questionnaire-9 (PHQ-9) Total Score From Baseline to Post-Program

    Baseline and end of 30-day intervention

  • Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score From Baseline to Post-Program

    Baseline and end of 30-day intervention

  • Change in Brief Pain Inventory Average Pain Score From Baseline to Post-Program

    Baseline and end of 30-day intervention

  • Change in Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score From Baseline to Post-Program

    Baseline and end of 30-day intervention

  • 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

  • +5 more secondary outcomes

Other Outcomes (2)

  • Participant-Reported Change in Selected Substance-Use Behaviors

    End of 30-day intervention

  • Post-Program Participant Questionnaire

    End of 30-day intervention

Study Arms (1)

WILD 5 Wellness Program

EXPERIMENTAL

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

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.

WILD 5 Wellness Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The GLOW Study

The Colony, Texas, 75056, United States

Location

Related Links

Study Officials

  • Saundra Jain, MA, PsyD, LPC

    The University of Texas at Austin School of Nursing

    PRINCIPAL INVESTIGATOR
  • Rakesh Jain, MD, MPH

    Texas Tech University Health Sciences Center School of Medicine - Permian Basin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saundra Jain, MA, PsyD, LPC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adjunct Clinical Affiliate

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations