Sleep Clinical Trial
— DFENDOfficial title:
Diet, Food, Exercise and Nutrition During Social Distancing
Verified date | May 2022 |
Source | University of Arkansas, Fayetteville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Our long-term goal is to contribute to the development of evidence-based nutritional and physical activity recommendations for the prevention and management of overweight and obesity and related chronic diseases. The overall objective for this study is to determine if a 20-week educational program, project DFEND, related to behavior change and health will improve nutrition and physical activity outcomes as well as indicators of wellbeing. Our central hypothesis is that regular attendance of weekly lectures, weekly meetings with personalized coaches, and weekly health challenges via virtual platforms (e.g. Zoom, Facebook, YouTube) will improve health outcomes related to nutrition and physical activity. Our rationale for these studies is that the results of this research will enhance the potential to develop evidence-based nutritional and physical activity behavioral recommendations to treat and/or prevent development of overweight and obesity.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Resides in Arkansas - All ethnicities - Female and male Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas | Fayetteville | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas, Fayetteville |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behavior change | Participants identify one behavior they want to change and work toward achieving that goal. This will be measured by recording goals and checking in weekly to record progress. We will use a 5-point likert scale to assess how well the participant perceives they are meeting their goal. Behavior change will be assessed qualitatively, relying on the participant to report success or failures to study personnel. | 20 weeks | |
Secondary | Sleep | Improved sleep determined by Pittsburg Sleep Quality Index questionnaire, which provides a subjective measure of sleep quality and patterns in the form of a validated questionnaire. The tool examines seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of sleep-promoting medication, and daytime dysfunction. | 20 weeks | |
Secondary | Mood | Improved mood determined by Profile of Mood States questionnaire which is a psychological rating scale used to assess transient, distinct moods. It measures six different dimensions of mood swings over a period of time using a five-point scale ranging from "not at all" to "extremely". | 20 weeks | |
Secondary | Physical Activity | Self-reported time spent participating in physical activity using the International Physical Activity Questionnaire, which is a standardized self-report questionnaire which provides and estimate of physical activity and sedentary behavior. | 20 weeks | |
Secondary | Dietary Intake | Self reported diet intake using 24 hour dietary recalls | 20 weeks |
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