Diet, Food, Exercise and Nutrition During Social Distancing

Not Applicable

Active, not recruiting

• Conditions: Mood; Healthy Eating; Healthy Lifestyle; Sleep
• Interventions: Behavioral: Education; Behavioral: Personalized coaching; Behavioral: Weekly behavior modification challenges

• Registration Number: NCT04754074
• Lead Sponsor: University of Arkansas, Fayetteville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study Start: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-03-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Resides in Arkansas
• All ethnicities
• Female and male

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Education and personalized coaching	Personalized coaching	-
Behavioral Education and personalized coaching	Education	-
Behavioral Education and personalized coaching	Weekly behavior modification challenges	-

Primary Outcome Measures

Name	Time	Method
Behavior change	20 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Sleep	20 weeks	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.
Mood	20 weeks	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".
Dietary Intake	20 weeks	Self reported diet intake using 24 hour dietary recalls
Physical Activity	20 weeks	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.

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States