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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04754074
Other study ID # DFEND3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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