Diet, Food, Exercise and Nutrition During Social Distancing

Sleep Clinical Trial

— DFEND  

Official title:

Diet, Food, Exercise and Nutrition During Social Distancing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04754074
• Other study ID #: DFEND3
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy Eating
• Healthy Lifestyle
• Mood
• Sleep

Intervention

Behavioral:
• Education
Weekly education related to behavior change
• Personalized coaching
Weekly calls with personalized coaches in behavior modification, nutrition, and physical activity/exercise.
• Weekly behavior modification challenges
Weekly challenges to address behavior change

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

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