NCT07760896招募中不适用
The GLOW Study: GLP-1 and Lifestyle for Optimal Wellness
Saundra Jain2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年9月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in HERO Wellness Scale Total Score From Baseline to Post-Program
研究概览
简要总结
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:
- Are there changes in participants' physical and emotional well-being after completing the 30-day wellness program?
- Are there changes in areas such as mood, anxiety, functioning, mindfulness, self-compassion, eating-related behaviors, pain, and positive wellness?
Participants will:
- Complete online questionnaires before and after the program.
- Follow the WILD 5 Wellness program for 30 days, which includes daily practices related to exercise, mindfulness, sleep, social connection, and nutrition.
- Complete a brief online tracking form each day during the 30-day program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: WILD 5 Wellness Program (Behavioral)
结局指标
主要结局
Change in HERO Wellness Scale Total Score From Baseline to Post-Program
时间窗: 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.
次要结局
- 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)
- Change in Mindful Attention Awareness Scale (MAAS) Total Score From Baseline to Post-Program(Baseline and end of 30-day intervention)
- Change in Sleep Condition Indicator (SCI) Total Score From Baseline to Post-Program(Baseline and end of 30-day intervention)
- Change in Social Connectedness Scale Total Score From Baseline to Post-Program(Baseline and end of 30-day intervention)
- 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)
- Change in Sheehan Disability Scale (SDS) Scores From Baseline to Post-Program(Baseline and end of 30-day intervention)
研究者
Saundra Jain
Adjunct Clinical Affiliate
University of Texas at Austin
研究点 (2)
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