NCT04754074

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

February 3, 2021

Last Update Submit

August 19, 2025

Conditions

Keywords

BehaviorNutritionPhysical activityDietExerciseSocial Distancing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Sleep

    20 weeks

  • Mood

    20 weeks

  • Physical Activity

    20 weeks

  • Dietary Intake

    20 weeks

Study Arms (1)

Behavioral Education and personalized coaching

EXPERIMENTAL
Behavioral: EducationBehavioral: Personalized coachingBehavioral: Weekly behavior modification challenges

Interventions

EducationBEHAVIORAL

Weekly education related to behavior change

Behavioral Education and personalized coaching

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

Behavioral Education and personalized coaching

Weekly challenges to address behavior change

Behavioral Education and personalized coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resides in Arkansas
  • All ethnicities
  • Female and male

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

BehaviorMotor Activity

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jamie Baum, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 15, 2021

Study Start

February 12, 2021

Primary Completion

March 31, 2025

Study Completion

December 31, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations