WILD 5 Wellness: A 90-Day Intervention (WILD = Wellness Interventions for Life's Demands)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Generalized Anxiety Disorder-7 (GAD-7)
研究概览
简要总结
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
详细描述
This study involves participating in a 90-day integrated, prescriptive, trackable wellness intervention, which includes five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition.
The intervention is divided into three phases (each spanning 30-days): Phase 1 - 'Boot Camp', Phase 2 - Solidify, and Phase 3 - Sustain. Program requirements include: Implementing 5 wellness interventions daily for the first 30-days, at least 5 days for the next 30-days, and at least 3 days for the final 30-days, documenting daily online adherence, completing daily wellness exercises to improve mental wellness, and completing online program forms prior to beginning the program, at 30-days, and again at 90-days.
Once eligibility is confirmed via the initial orientation/screening call, study personnel will mail each participant a WILD 5 Wellness Workbook within one day of emailing participants their unique identification codes plus their start dates. Participants will be instructed to document adherence regarding their daily wellness practices and their daily wellness exercises online via Qualtrics, an online survey software. Participants can document their daily adherence using their computer and/or their smartphone as Qualtrics offers a mobile version of the Participant Tracking Form. A copy of the Participant Tracking Form will also be available in the WILD 5 Workbook so participants that prefer keeping a daily paper log can do so, and they can then transfer their program adherence information to the online Participant Tracking Form throughout the program. The workbook will contain the participant's personal identification code; no personal identification will appear in the workbook in order to protect participant confidentiality.
One day prior to a participant's start date, which will be set during the orientation/screening call, participants will receive an automated email from an online automated email service (MailChimp), with a reminder about their start date, and encouragement to contact study personnel with any questions or concerns.
Participants will also receive daily motivational emails from an online automated email service (MailChimp), which will provide general information about one of the five wellness elements and/or one of the wellness exercises, as well as encouragement to track their participation on a daily basis, and encouragement to contact study personnel via email with any questions and/or concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Adults (18 years of age or older)
- •English- speaking
- •Access to a reliable Internet-enabled computer
- •Possess basic computer skills
- •Self-identify as having at least one of the health conditions listed on the online registration form or
- •Self-identify as a community participant without a health condition.
排除标准
- •Acutely suicidal and/or actively psychotic
- •Non-English speaking
- •Do not have access to an Internet-enabled computer
- •Report a lack of basic computer skills
- •Pregnant or plan to get pregnant during the next 90-days.
研究组 & 干预措施
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 1 - Exercise (Behavioral)
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 2 - Mindfulness (Behavioral)
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 3 - Sleep Hygiene (Behavioral)
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 4 - Social Connectedness (Behavioral)
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 5 - Nutrition (Behavioral)
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 6 - Wellness Exercises (Behavioral)
Wellness Intervention
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
干预措施: Wellness Element 7 - Motivational Messages (Behavioral)
结局指标
主要结局
Change in Generalized Anxiety Disorder-7 (GAD-7)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A self-reported questionnaire used to assess anxiety symptoms.
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A self-reported depression scale used to assess severity of depression.
Change in The Social Connectedness Scale (SCS)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that assesses the degree to which respondents feel connected to others.
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Change in The WILD 5 Wellness Scale (W5WS)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale designed specifically for this project to measure wellness.
Change in The Sleep Condition Indicator (SCI)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that evaluates insomnia disorder.
Change in The Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)
时间窗: 0, 30, and 90 - Primary endpoint is 30 days
A combination of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets shown to lower a person's risk of developing Alzheimer's disease.
Change in World Health Organization-5 (WHO-5)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that measures mental well- being.
Change in The Mindful Attention Awareness Scale (MAAS)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A popular measure of mindfulness.
Change in The Sheehan Disability Scale (SDS)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A measurement tool for assessing functional impairment in three inter-related domains: work/school, social and family life.
Change in The Endicott Work Productivity Scale (EWPS)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A brief self-report questionnaire designed to obtain a sensitive measure of work productivity.
Change in The WILD 5 Wellness Elements Scale
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A scale designed specifically for this project to measure elements of depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, diet practices, pain, disability, work productivity, happiness, enthusiasm, resilience, and optimism.
Change in The Brief Pain Inventory (BPI)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A measurement tool for assessing clinical pain.
Change in The WILD 5 Wellness Effort Scale (W5ES)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A scale designed specifically for this project to measure weekly adherence with program elements.
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
时间窗: 0, 30, and 90 days - Primary endpoint is 30 days
A brief scale that measures cognitive and executive dysfunction.
The Post-Program Participant Questionnaire
时间窗: 90 days
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
次要结局
未报告次要终点
研究者
Saundra Jain
Adjunct Clinical Affiliate, School of Nursing
University of Texas at Austin