Healthy LifestyleDFENDNCT04754074
Diet, Food, Exercise and Nutrition During Social Distancing
A study testing Education, Personalized coaching and Weekly behavior modification challenges in people with Healthy Lifestyle and Sleep, run by University of Arkansas, Fayetteville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Sleep, Mood
- What is being tested?
- Education, Personalized coaching and Weekly behavior modification challenges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resides in Arkansas
- All ethnicities
- Female and male
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
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.
Read more
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.
- Conditions
- Healthy Lifestyle, Sleep, Mood, Healthy Eating
- Being tested
- Education, Personalized coaching, Weekly behavior modification challenges
- Keywords
- Behavior, Nutrition, Physical activity, Diet, Exercise, Social Distancing
- Medical subject headings
- Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Weekly education related to behavior change
Personalized coachingBehavioural
Weekly calls with personalized coaches in behavior modification, nutrition, and physical activity/exercise.
Weekly behavior modification challengesBehavioural
Weekly challenges to address behavior change
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Education and personalized coaching | Experimental | Not described Receives: Behavioral: Education; Behavioral: Personalized coaching; Behavioral: Weekly behavior modification challenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Secondary outcomes (4)
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.
Measured: 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".
Measured: 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.
Measured: 20 weeks
Dietary Intake
Self reported diet intake using 24 hour dietary recalls
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start12 Feb 2021
- Primary completion31 Mar 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie Baum, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754074
- Sponsor's protocol ID
- DFEND3
- Acronym
- DFEND
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Food, Exercise and Nutrition During Social Distancing
- ClinicalTrials.gov ID
- NCT04754074
- Acronym / sponsor ID
- DFEND / DFEND3
- Conditions
- Healthy Lifestyle, Sleep, Mood, Healthy Eating
- Keywords
- Behavior, Nutrition, Physical activity, Diet, Exercise, Social Distancing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Education and personalized coaching | Experimental | Behavioral: Education, Behavioral: Personalized coaching, Behavioral: Weekly behavior modification challenges |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resides in Arkansas
- All ethnicities
- Female and male
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationWeekly education related to behavior change | Behavioural | Behavioral Education and personalized coaching |
| Personalized coachingWeekly calls with personalized coaches in behavior modification, nutrition, and physical activity/exercise. | Behavioural | Behavioral Education and personalized coaching |
| Weekly behavior modification challengesWeekly challenges to address behavior change | Behavioural | Behavioral Education and personalized coaching |
Primary outcome
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.
4 secondary outcomes
Sleep
Time frame: 20 weeks
Mood
Time frame: 20 weeks
Physical Activity
Time frame: 20 weeks
Dietary Intake
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Baum, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Personalized coaching and Weekly behavior modification challenges in people with Healthy Lifestyle and Sleep, run by University of Arkansas, Fayetteville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior change (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.