Diet, Food, Exercise and Nutrition During Social Distancing

Study Overview
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Brief Summary
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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.

Official Title
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Diet, Food, Exercise and Nutrition During Social Distancing

Conditions
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Sleep, Healthy Lifestyle, Mood, Healthy Eating

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Personalized coaching
* Behavioral: Weekly behavior modification challenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resides in Arkansas All ethnicities Female and male Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Education and personalized coaching<br> | Behavioral: Education<br>* Weekly education related to behavior change<br>Behavioral: Personalized coaching<br>* Weekly calls with personalized coaches in behavior modification, nutrition, and physical activity/exercise.<br>Behavioral: Weekly behavior modification challenges<br>* Weekly challenges to address behavior change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Dietary Intake | Self reported diet intake using 24 hour dietary recalls | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior, Nutrition, Physical activity, Diet, Exercise, Social Distancing