PowerObesity: Community Lifestyle Interventions to Prevent and Improve Mental Health of Minorities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Patient Health Questionnaire (PQ-9) Test
Study Overview
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.
Detailed Description
Research plan A. Significance A.1 Rationale The obesity epidemic in the north American population is a growing concern amongst the scientific community. Diabetes and cardiovascular disease have been shown to be significantly influenced by obesity. The Centers for Disease Control and Prevention (CDC) defines obesity as having a body mass index (BMI) greater than or equal to 30 m/kg2, which is determined by a person's height and weight. A recently published systematic analysis of body mass index in 199 countries and territories showed a trending increase in the BMI of individuals in the United States alone from 1980 to 2008, ranking the highest in both male and female BMI ranges for high income countries . The United States also ranked the highest for obesity rates (23.9%) in a study analyzing possible correlations between obesity and active transportation in Europe, North America, and Australia . In addition, a study looking at the overall increasing trend of obesity in America estimated that with the current annual progression of obesity rates in America, that 86.3% of adults will be obese by 2030 . Women of non-Hispanic African descent are 56.7% obese, while Latinas are 44.4% obese . There is a need for affordable health programs that could available to the general population. Another program facing the community in the area of study is mental health problems. According to the World Health Organization, depression is "the leading cause of disability worldwide" and "a major contributor to the overall global burden of disease" . This accumulating problem leads many towards dysfunction, decreased efficiency, loss in quality health, increased addictive behaviors, and even suicide. Also, studies show that major depression and alcohol dependence were "associated with heavy cigarette use and poor smoking-treatment outcomes . In their study the investigators demonstrated that programs that improve overall health can also improve mental health , .
A facilitated lifestyle-based program like the Complete Health Improvement Program (CHIP) has been shown to help lose weight, lower their risks of heart disease and mental health . Through a balanced approach, program participants are instructed on how to make healthier food choices, incorporate regular physical activity into their daily lives, learn stress management techniques, and stop using tobacco (if applicable).
A.2 Can a lifestyle education program work for mental health and obesity? Community education programs that deal with the root causes of the problems are very effective in changing behavior and improving overall health . Some of the root issues with obesity and mental health. The program focuses on improving lifestyle of participants. These are some of the lifestyle interventions that will be used and their effectiveness.
Healthy diet Healthy lifestyles involve eating a balanced diet, maintaining a healthy weight, working out regularly, being low to moderately stressed, not smoking, and limiting alcohol consumption. A healthy diet has been proven to lower the risk of heart disease. The Mediterranean Diet, for instance, has been shown to lower heart disease risk by up to 70% compared to dieting alone . In addition, nearly half of the money Americans spend on food is spent at fast-food restaurants, which is double what was spent in 1955 . Fat, sugar, and salt are typically high in restaurant meals, which can contribute to heart disease. found that a healthy diet contains a balance of essential nutrients, calories, carbohydrates, fats, and protein, which reduces the risk of heart disease .
Reducing body weight An additional contributor to these diseases is obesity. The effects of obesity on cardiovascular disease and diabetes have been well documented. Obese individuals are at risk for a variety of health issues, including high cholesterol, diabetes, hypertension, heart disease, and stroke . Coronary heart disease, also known as coronary artery disease, is one of the deadliest health issues associated with obesity. The National Institutes of Health (NIH) reports that your arteries can become narrow as a result of fat, cholesterol, and calcium building up and forming plaque in your arteries . Angina, shortness of breath, and arrhythmia are some of the signs and symptoms of coronary heart disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Patient Health Questionnaire (PQ-9) Test
Time Frame: Taken at 12 months of intervention
Measures depression using Patient Health Questionnaire (PQ-9). Total score ranges from 0 to 27. The higher the score means a worse outcome.
Depression and Anxiety Assessment Test
Time Frame: Taken at 12 months of intervention
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.
Generalized Anxiety Disorder (GAD-7) Test
Time Frame: Taken at 12 months of intervention
Measures depression using the Generalized Anxiety Disorder (GAD-7). Total score ranges from 0 to 21. The higher the score means a worse outcome.
Secondary Outcomes
No secondary outcomes reported
Investigators
Eddie Ramirez
Research Assistant Professor
Charles Drew University of Medicine and Science
