A Mental Health Intervention for a Community Program Called the PowerObesity
NCT05605028 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-04-01
Summary
The intervention will focus on identifying risk factors for depression and anxiety and will quantitate the educational component of the POWER Obesity group intervention delivered by mental health professionals that are currently presenting for 30 min during the Monday session to address the root causes of obesity as well as to encourage positive lifestyle changes (e.g. sleep, diet, sun exposure, circadian rhythms, and addictions). The previously published hypothesis identifies triggers, that combined, could cause mental health problems. The 10 groups of triggers are: (1) Genetic, (2) Developmental, (3) Lifestyle, (4) Circadian Rhythm, (5) Addiction, (6) Nutrition, (7) Toxic, (8) Social/Complicated Grief, (9) Medical Condition, and (10) Frontal Lobe. Each of these factors will be dealt with in the lifestyle intervention. The project will be led by the assistant professor (in process) Francisco E Ramirez, MD with his mentor Theodore Friedman, MD, PhD supervising the project.
Hypothesis:
The investigators hypothesize that composite POWER Obesity group will have greater improvement in mental health compared to the dietitian-led group.
Measuring outcomes:
The intervention will take 1 year to recruit all the patients the investigators expect to have the 75 patients in the group intervention and 25 patients in the dietitian-led group. With these numbers, our preliminary power analysis suggests there will be a difference in the two groups with an alpha of .05 and 80% power. The investigators will add 3 tests to both arms of the study, 9-question Patient Health Questionnaire (PQ-9), Generalized Anxiety Disorder (GAD), and the Depression and Anxiety Assessment Test, in the POWER Obesity group at 0, 3, 6 months and 12 months of intervention.
Conditions
- Mental Health Wellness 1
- Depression
- Anxiety
- Sedentary Behavior
- Obesity
- Poor Nutrition
Interventions
- BEHAVIORAL
-
Mental Health lifestyle intervention
The focus is to identify 10 potential groups of causes and working on reversing them. The 10 factors are: (1) Genetic, (2) Developmental, (3) Lifestyle, (4) Circadian Rhythm, (5) Addiction, (6) Nutrition, (7) Toxic, (8) Social/Complicated Grief, (9) Medical Condition, and (10) Frontal Lobe. Each of these factors will be dealt with in the lifestyle intervention.
- OTHER
-
Dietitian-led
A group of people that visit the dietitian will be used as comparison against the Mental Health lifestyle intervention
Sponsors & Collaborators
-
Charles Drew University of Medicine and Science
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-09-02
- Primary Completion
- 2025-12-02
- Completion
- 2025-12-30
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