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NCT05605028
A Mental Health Intervention for a Community Program Called the PowerObesity
Conditions: Mental Health Wellness 1, Depression, Anxiety, Sedentary Behavior, Obesity, Poor Nutrition
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Charles Drew University of Medicine and Science
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.
Eligibility Criteria
Inclusion Criteria:Participants must be 18 or older,BMI > 30 kg/m2Open to either being part of a group visit or being coached by a dietitian.Must be currently receiving care at LAC-DHS or be eligible for this care and be enrolled in a primary care provider (PCP) capable of adjusting their medicines, including anti-hypertensive and diabetic medications,It is not necessary to have diabetes or hypertension in addition to obesity to enroll.Exclusion Criteria:Currently participating of an obesity treatment programCurrently taking weight loss medications such as orlistat, lorcaserin, phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine, and benzphetamine They can enroll if they have stopped taking weight loss medicine for at least two months.Those actively suicidal.
Source: ClinicalTrials.gov (NCT05605028). StuddyBuddy aggregates publicly available trial information.