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OpenTrials
Active, Not Recruiting

NCT Number: NCT04754074

Diet, Food, Exercise and Nutrition During Social Distancing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Lifestyle Behavior Healthy Eating Mood Motor Activity Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resides in Arkansas
  • All ethnicities
  • Female and male

Exclusion criteria

  • None

Treatment and study plan

Education

Behavioral

Weekly education related to behavior change

Personalized coaching

Behavioral

Weekly calls with personalized coaches in behavior modification, nutrition, and physical activity/exercise.

Weekly behavior modification challenges

Behavioral

Weekly challenges to address behavior change

Primary outcomes

  1. Behavior change

    Time frame: 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 outcomes

  1. Sleep

    Time frame: 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.

  2. Mood

    Time frame: 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".

  3. Physical Activity

    Time frame: 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.

  4. Dietary Intake

    Time frame: 20 weeks

    Self reported diet intake using 24 hour dietary recalls

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Acronym: DFEND

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2021
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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