Educational Program for a Healthy Lifestyle

(DFEND Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas, Fayetteville

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on lifestyle changes rather than medication use.

What data supports the effectiveness of the Educational Program for a Healthy Lifestyle treatment?

Research shows that educational programs focusing on patient involvement and personalized coaching can lead to better health outcomes, such as improved quality of life and increased engagement in treatment. For example, therapeutic education in diabetes has been shown to improve patient compliance and reduce complications, while similar programs for chronic illnesses help patients manage their conditions and adapt their lifestyles. ^{1 2 3 4 5}

Is the Educational Program for a Healthy Lifestyle safe for humans?

Educational programs, including psychoeducation and health education, have been used safely in various settings, such as for patients with mental health conditions. These programs focus on providing information and skills to help individuals understand and manage their conditions better, and no significant safety concerns have been reported in the studies reviewed. ^{6 7 8 9 10}

How is the Educational Program for a Healthy Lifestyle treatment different from other treatments for mental health?

This treatment is unique because it combines education, personalized coaching, and weekly behavior modification challenges to promote a healthy lifestyle, focusing on mental health education and coping strategies, unlike traditional treatments that may not integrate these elements. ^{11 12 13 14 15}

Research Team

Jamie Baum, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for Arkansas residents of any ethnicity, both female and male, interested in improving their nutrition and physical activity to prevent or manage overweight and obesity. It aims to help with healthy eating, sleep, lifestyle habits, and may also benefit those feeling depressed.

Inclusion Criteria

Resides in Arkansas

All ethnicities

I am either female or male.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Program

Participants engage in a 20-week educational program, project DFEND, involving weekly lectures, meetings with personalized coaches, and health challenges via virtual platforms

20 weeks

Weekly virtual meetings

Follow-up

Participants are monitored for improvements in nutrition, physical activity, mood, sleep, and dietary intake

4 weeks

Treatment Details

Interventions

• Education
• Personalized coaching
• Weekly behavior modification challenges

Trial Overview The study tests a 20-week educational program called project DFEND. Participants will attend weekly lectures on health, meet with personal coaches for tailored advice, and take part in behavior modification challenges through virtual platforms like Zoom.

Participant Groups

Group I: Behavioral Education and personalized coaching Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Findings from Research

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

Patient education programs can significantly enhance self-management of chronic illnesses like diabetes, which is crucial for prevention and lifestyle modification.

Evaluating the effectiveness of these programs is complex due to various influencing factors, including patient demographics, disease characteristics, and healthcare system dynamics, all of which must be considered in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures and methods in evaluating patient education programs for chronic illness. Lane, DS., Evans, D.[2019]

Therapeutic education significantly improves patients' quality of life and treatment compliance, leading to remarkable outcomes such as an 80% reduction in amputations over 10 years for diabetic patients.

Motivational interviewing techniques are crucial in helping patients change their behaviors gradually, making them active partners in their treatment and enhancing their ability to manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education of the diabetic patient]. Golay, A., Lagger, G., Chambouleyron, M., et al.[2015]

A randomized multicenter study in Munich demonstrated that a psychoeducation program significantly reduced rehospitalization rates for patients with schizophrenia from 58% to 41% over two years.

The program also led to a decrease in the number of days spent in the hospital, from 78 to 39 days, highlighting its efficacy in improving patient outcomes and supporting the need for such programs to be available to all affected individuals and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation: a basic psychotherapeutic intervention for patients with schizophrenia and their families. Bäuml, J., Froböse, T., Kraemer, S., et al.[2022]

A computer-delivered psycho-education program was well-received by patients in forensic psychiatry, with participants (n=10) finding it easy to use and enjoyable, which suggests good user engagement.

The study indicates that this CD-ROM approach is an effective method for educating patients about psychosis, particularly appealing to younger individuals who are more comfortable with technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based education for patients with psychosis. Walker, H.[2016]

A school program was developed in Italy to promote mental health and prevent mental illness, featuring a manual with 18 chapters focused on essential skills like communication, problem-solving, and stress management.

The manual was positively received by 253 students across 10 high schools and 1 middle school, indicating its acceptability, while its effectiveness in promoting mental health is still under evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A student manual for promoting mental health among high school students. Gigantesco, A., Del Re, D., Cascavilla, I.[2019]

The Inner North Brisbane Mental Health Service implemented a structured Healthy Living Program with three modules focusing on Nutrition, Physical Health, and Community Activities, which received positive feedback from participants, indicating satisfaction and intention to adopt healthier lifestyle changes.

While the program has shown immediate positive responses from participants, further research is needed to assess the long-term impact of the program on health and well-being among mental health service recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the health and lifestyle issues of people with a mental illness: the Healthy Living Programme. O'Sullivan, J., Gilbert, J., Ward, W.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Do it yourself. Medication management for community based clients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Measures and methods in evaluating patient education programs for chronic illness. [2019]

4. Belgium pubmed.ncbi.nlm.nih.gov

[Therapeutic education of the diabetic patient]. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

[Pilot study for evaluating patient education in asthma, bronchitis, emphysema with the support of the Bad Reichenhall Research Institute for Diseases of Respiratory Organs, Inc]. [2009]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Health Education on the Quality of Life of Patients Hospitalized in Forensic Psychiatry Wards. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Psychoeducation: a basic psychotherapeutic intervention for patients with schizophrenia and their families. [2022]

8. England pubmed.ncbi.nlm.nih.gov

An ethnographic study of the incentives and barriers to lifestyle interventions for people with severe mental illness. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

A psychoeducational approach to educating chronic mental patients for community living. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Computer-based education for patients with psychosis. [2016]

11. Italy pubmed.ncbi.nlm.nih.gov

A student manual for promoting mental health among high school students. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The recovery education center: an integrated health promotion and wellness program. [2011]

13. United States pubmed.ncbi.nlm.nih.gov

MasterMind: Empower Yourself With Mental Health. A program for adolescents. [2008]

14. United States pubmed.ncbi.nlm.nih.gov

Supported education: an additional program resource for young adults with long term mental illness. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Addressing the health and lifestyle issues of people with a mental illness: the Healthy Living Programme. [2017]