A Mental Health Intervention for a Community Program Called the PowerObesity

NCT05605028 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-04-01

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605028 on ClinicalTrials.gov