A Mental Health Intervention for a Community Program Called the PowerObesity

NCT05605028 | Withdrawn DMC

• 1 other identifier: Mental Health for PowerObesity
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (12)

• Patient Health Questionnaire (PQ-9) Test

  Measures depression using Patient Health Questionnaire (PQ-9). Total score ranges from 0 to 27. The higher the score means a worse outcome.

  Taken at baseline.

• Patient Health Questionnaire (PQ-9) Test

  Measures depression using Patient Health Questionnaire (PQ-9). Total score ranges from 0 to 27. The higher the score means a worse outcome.

  Taken at 3 months of intervention

• Patient Health Questionnaire (PQ-9) Test

  Measures depression using Patient Health Questionnaire (PQ-9). Total score ranges from 0 to 27. The higher the score means a worse outcome.

  Taken at 6 months of intervention

• Patient Health Questionnaire (PQ-9) Test

  Measures depression using Patient Health Questionnaire (PQ-9). Total score ranges from 0 to 27. The higher the score means a worse outcome.

  Taken at 12 months of intervention

• Generalized Anxiety Disorder (GAD-7) Test

  Measures depression using the Generalized Anxiety Disorder (GAD-7). Total score ranges from 0 to 21. The higher the score means a worse outcome.

  Taken at baseline

• Generalized Anxiety Disorder (GAD-7) Test

  Measures depression using the Generalized Anxiety Disorder (GAD-7). Total score ranges from 0 to 21. The higher the score means a worse outcome.

  Taken at 3 months of intervention

• Generalized Anxiety Disorder (GAD-7) Test

  Measures depression using the Generalized Anxiety Disorder (GAD-7). Total score ranges from 0 to 21. The higher the score means a worse outcome.

  Taken at 6 months of intervention

• Generalized Anxiety Disorder (GAD-7) Test

  Measures depression using the Generalized Anxiety Disorder (GAD-7). Total score ranges from 0 to 21. The higher the score means a worse outcome.

  Taken at 12 months of intervention

• Depression and Anxiety Assessment Test

  Measures depression and causes of depression using the Depression and Anxiety . Assessment Test. It reports which of 10 possible triggers of depression the patient has at the moment the test was taken. The text triggers are: Genetic, Developmental, Lifestyle, Circadian Rhythm, Addiction, Nutrition, Toxic, Social/Complicated Grief, Medical Condition, and Frontal Lobe.

  Taken at baseline

• Depression and Anxiety Assessment Test

  Measures depression and causes of depression using the Depression and Anxiety . Assessment Test. It reports which of 10 possible triggers of depression the patient has at the moment the test was taken. The text triggers are: Genetic, Developmental, Lifestyle, Circadian Rhythm, Addiction, Nutrition, Toxic, Social/Complicated Grief, Medical Condition, and Frontal Lobe.

  Taken at 3 months of intervention

• Depression and Anxiety Assessment Test

  Measures depression and causes of depression using the Depression and Anxiety . Assessment Test. It reports which of 10 possible triggers of depression the patient has at the moment the test was taken. The text triggers are: Genetic, Developmental, Lifestyle, Circadian Rhythm, Addiction, Nutrition, Toxic, Social/Complicated Grief, Medical Condition, and Frontal Lobe.

  Taken at 6 months of intervention

• Depression and Anxiety Assessment Test

  Measures depression and causes of depression using the Depression and Anxiety . Assessment Test. It reports which of 10 possible triggers of depression the patient has at the moment the test was taken. The text triggers are: Genetic, Developmental, Lifestyle, Circadian Rhythm, Addiction, Nutrition, Toxic, Social/Complicated Grief, Medical Condition, and Frontal Lobe.

  Taken at 12 months of intervention

Study Arms (2)

Mental Health lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Mental Health lifestyle intervention

Dietitian-led

ACTIVE COMPARATOR

A group of participants that visit a dietitian will be the control.

Other: Dietitian-led

Interventions

Mental Health lifestyle intervention BEHAVIORAL

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.

Also known as: 10 hit hypothesis intervention

Mental Health lifestyle intervention

Dietitian-led OTHER

A group of people that visit the dietitian will be used as comparison against the Mental Health lifestyle intervention

Dietitian-led

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 or older,
• BMI \> 30 kg/m2
• Open 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.

You may not qualify if:

• Currently participating of an obesity treatment program
• Currently 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.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Related Publications (1)

• Nedley N, Ramirez FE. Nedley Depression Hit Hypothesis: Identifying Depression and Its Causes. Am J Lifestyle Med. 2016 Nov;10(6):422-428. doi: 10.1177/1559827614550779. Epub 2014 Nov 10.

  PMID: 27885322 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sedentary Behavior; Obesity; Malnutrition

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 3, 2022
• Study Start: September 2, 2023
• Primary Completion: December 2, 2025
• Study Completion: December 30, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03