Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05605028 |
| Other study ID # |
Mental Health for PowerObesity |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2023 |
| Est. completion date |
December 30, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Charles Drew University of Medicine and Science |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
- Exercise 150 minutes of moderate intensity physical activity per week can improve
cholesterol levels . In the intervention the investigators are proposing, physical
activity recommendations serve as guidelines improve overall health. Physical activity
rates and obesity rates among Americans emphasize the importance of focusing on fitness
and weight management. The American Heart Association reports that only 49.1% of
American adults met the recommended physical activity standards . The Centers for
Disease Control and Prevention (CDC) data show that 24.1% of American adults did not
participate in leisure-time physical activity that same year. Compared to 1950, the
number of sedentary occupations has increased by 83%, while the number of physically
active jobs has decreased by 25% , .
- Control of stress Mental health, obesity and other problems are also associated with
stress. A person's heart rate and blood pressure increase when they are faced with a
stressful situation . There is also evidence that individuals suffering from anxiety,
depression, and anger are more likely to develop heart disease . When examining current
American lifestyles, which are characterized by chronic stress, this information can be
cause for concern. Therefore, Americans may be at increased risk for multiple health
problems. Furthermore, many Americans find it difficult to balance work, finances,
family life, and time to practice healthy habits .
A.3 Nutrition therapy Dietitians (RDs) and nutritionists (RDNs) provide food and nutrition
education as well as medical nutrition therapy . In both short- and long-term studies and in
both group and individual settings, Micronutrient test (MNT) administered by a RD or RDN is
associated with significant weight loss both statistically and clinically. Dietitian-led
individualized visits provide a control for the study.
A.4 Medical Group visits The group visit is not the same as a class or group therapy session
and clearly differs from other for-profit models which do not address health disparities
directly or mitigate them. These models have been used to conduct group visit programs for a
variety of medical conditions in multiple practice settings , . When compared with standard
individual medical visits, medical group visits have been shown to be associated with
clinically significant improvements in a variety of medical, psychological, and behavioral
outcomes , , . Medical group and high-risk populations, such as elderly patients , medical
group visits have proven to be highly effective methods for improving access to medical care
and monitoring complex chronic diseases. The utilization of emergency departments and
outpatient services is decreased in patients treated through medical group visits, their
quality-of-life increases, and their satisfaction with their care is higher .
A.5 Gaps in evidence in treating depression Depression is usually treated in primary care
settings using pharmacotherapy and psychotherapy as mainstays of treatment. Most patients
with depression are treated by their primary care provider; approximately 5% to 10% of all
patients at primary care clinics receive depression treatment . In almost 90% of cases,
clinicians recommend antidepressant medications alone or in conjunction with psychotherapy to
their patients who are diagnosed as suffering from depression . Antidepressants are currently
the most prescribed class of medication in the U.S. , . Such medications as serotonin
reuptake inhibitors, monoamine oxidase inhibitors, tricyclic antidepressants, and other
atypical formulations target the dysregulation of neurotransmitters found in depression .
Chronic illnesses, including depression, can be influenced by lifestyle and environmental
factors, which are often overlooked. Researchers estimate that up to 80% of chronic diseases,
such as heart disease, stroke, and diabetes, are caused by lifestyle choices and
environmental factors , . A substantial portion of the variance in susceptibility to chronic
diseases can be attributed to lifestyle factors and environmental factors , . Poor nutrition,
physical inactivity, poor sleep hygiene, unmanaged stress, social isolation, and substance
abuse are some examples , . Lifestyle medicine focuses on modifying these maladaptive
lifestyle behaviors. The American College of Lifestyle Medicine defines lifestyle medicine as
an evidence-based medical practice that promotes health and well-being through evidence-based
therapeutic lifestyle modalities .
Positive lifestyle changes can reduce depression in several ways. The Mediterranean diet,
which incorporates a higher intake of fruits and vegetables, has been associated with a
decreased risk of depression . Studies have shown that moderate exercise of 20 minutes per
day, 3 times per week can help reduce depression symptoms . Sleep hygiene interventions have
been shown to reduce depression symptoms without pharmacological interventions . Active
leisure can contribute to better mental health, especially for those who are unemployed, by
increasing their perception of spending their time efficiently and effectively .
Evidence-based training can help relieve mood disorders such as anxiety and depression , .
Intimate and supportive relationships with family, friends, or significant others have been
shown to be beneficial to mental health . Individuals who feel as though their lives have
meaning tend to manifest fewer symptoms of depression .
A.6 10 hit hypothesis approach to mental health improvement The intervention will focus on
identifying risk factors for depression and anxiety and will quantitate the educational
component of the intervention delivered by mental health professionals that are currently
presenting for 30 min during the Monday session to address the root causes as well as to
encourage positive lifestyle changes (e.g. sleep, diet, sun exposure, circadian rhythms, and
addictions). The previously published hypothesis . The hypothesis proposed by Nedley and
Ramirez 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.
B. Innovation The innovating proposal is to use medical group visit to encourage positive
lifestyle changes that not only will have an impact on weight control but also on mental
health in which the minorities around the institution will benefit. The control group will be
a dietitian led program that provides obesity care for the inner-city population. The
investigators will measure depression and anxiety as well as try to identify causes of
depression and anxiety to encourage people to do the changes proposed. By the help of this
Accelerating Excellence in Translational Science (AXIS) grant the investigators will be able
to help the Los Angeles County (LAC)-Department of Health Services (DHS) population. This
approach if successful could be replicated to improve obesity and mental health care in a
sustainable way that could impact many people.
C. Approach C.1a Martin Luther King (MLK) POWER obesity group visit Endocrinologist Dr.
Theodore Friedman (PI) and colleagues at the Martin Luther King Jr. Multi-Service Ambulatory
Care Center (MLK MACC) [the name of the center changed to Martin Luther King Jr. Outpatient
Center (MLK OC)] began providing obesity group visits in January 2013. The clinic, named
POWER (Preventing Obesity With Eating Right), is open weekly on Monday afternoons for about 2
1/2 hours and patients can attend weekly or monthly. In 2014, the investigators changed the
format to have English sessions on the 1st, 2nd and 5th Mondays and Spanish sessions on the
2nd and 4h Mondays. University of California, Los Angeles (UCLA) Clinical and Translational
Research Institute (CTSI) provided funding to the Charles R. Drew University (CDU) through a
research infrastructure grant, of which CDU is an equal partner. Using the preliminary
funding, the investigators were able to obtain CDU Institutional Review Boards (IRB)
approval, set up a database to track patients, hire a part-time coordinator, and increase the
number of patients who attended clinics in person and via video conferencing. The
investigators were able to set up an infrastructure for the proposed study through the pilot
funding, allowing us to start recruiting patients for the pragmatic study immediately
following funding. Power analysis can also be based on the data collected.
Our current POWER group visit at MLK begins with registration, vital signs, and 20 minutes of
fitness. In this period, new subjects are informed they are part of an IRB-approved study
that collects and anonymizes their data. Participants in the study are consented by the study
coordinator (90% have consented). In a 30-minute overview, Dr. Friedman or another expert
discusses the differences between diet and long-term lifestyle changes focusing on the
complications of uncontrolled obesity and the benefits of weight loss, the importance of a
plant-based diet, and physical activity. Each participant is then given a physical activity
"prescription", both aerobic and strength training, on a prescription pad. Providers from
orthopedics, mental health, and dentistry are frequent guest lecturers who discuss how
obesity affects their fields. This visit concludes with a lecture by our dietitian using the
curriculum. "Instant Recess" (which incorporates physical activity breaks into the daily
routine to boost health and productivity) is discussed and our dietitian offers a lecture
based on the curriculum. During the meeting, individuals are encouraged to ask lots of
questions and to discuss their successes and barriers with the physician and with one
another. The sessions last about 2 1/2 hours, and surveys indicate that participants are
satisfied with the length and duration of the program. Each visit follows a standardized
format. There are, however, updates to the slides and a variety of topics are discussed so
that patients can get new information at subsequent appointments. On October 8, 2013, the
Spanish language television station Univision profiled the obesity group visit program on its
front page. The fitness was included in the visit in January 2011 and was highlighted on both
the Channel ABC7 evening news and Univision evening news on August 10, 2015.
C.1b Pilot study The Power Clinic pilot IRB was approved in October 2013, 651 patients
consented for that pilot program. Most of patients had diabetes or prediabetes. Regarding
weight lost 30% of them lost at least 8 pounds. 12% lost at least 5% of their weight. Those
who came more often showed better results. Most participants were satisfied with their
experience and results. Input was taken from the patients, and they wanted the program to
continue, the investigators also took many of their comments and improved the program
overall.
As a result, our preliminary data indicates a solid infrastructure, recruitability, and
success. Thus, the investigators are in a good position to implement the mental health
proposal as soon as it is funded, the investigators only need a CDU IRB amendment for its
approval.
C 1.c Mental health component. The mental health component to the intervention will be based
on the 10 hit hypothesis. That approach has more than 80 presented abstract in various
scientific meetings showing the effectiveness of applying lifestyle interventions , .
C.2 Study Design and approach. The investigators will do a randomization of the participants
for the 18 months comparing those seeing a dietitian and those that will be learning about
the 10-hit hypothesis. The study will randomize 75 participants with a 3:1 block ratio goal.
By increasing the number of participants in the intervention group of the novel approach to
mental health and to decrease the load of the dietitian led group. Participants can't choose
which group to belong in order to improve the randomization of the trial. Patients cannot be
in both arms of the study.
The recruitment method will be the same that was used to get the current Power Obesity group.
The investigators will invite patients from obesity group to this sub study. Every patient
that wants to participate of this mental health component need to consent. Both arms of the
study are evidenced based the investigators will have minimum risk. If a participant does not
want to consent, the investigators will provide them with a list of other options for them to
benefit.
The group visits, 2 and a half days will be in Spanish and 2 and a half group will be in
English. Each visit 2 ½ hours. For the dietician group of the study the intervention will be
offered in English and Spanish. Participants can participate of the program if they want. The
investigators will use 12 months of data for the study. Los Angeles county will benefit from
both legs of the study of this cost-effective approach.
C.3.a Approach of both study arms.
The emphasis of the Power Obesity is to promote healthy behaviors: a) decrease refined foods.
B) decreased consumption of simple refined carbohydrates c) decrease sugary beverages d) a
goal of 150 min of aerobic exercise and 30 minutes of anaerobic exercise. Both groups will be
assessed by the:
the International Physical Activity Questionnaire (IPAQ) which assessed the amount of
exercise the participant does.
C 3.b Composite group visit. It will have all the element of the visit. 1) a lecture by an
expert, 2) Guided exercise, 3) exercise prescription, delivery of the curriculum outlined by
the National Diabetes Prevention Program. The visits will be documented in medical records in
a system call ORCHID. The duration is going to be 2 ½ hours. The intervention will be offered
in Spanish and English. In addition to the usual curriculum the mental health component. The
mental health presentation will cover various areas from defining depression and anxiety, to
what contributes to it, to who is at risk for these disorders and if recovery is possible.
The investigators will have share for 20 minutes an evidenced based mental health component.
Participants will be encouraged to adequately hydration, listen to more music therapy, begin
or continue a good exercise program, and develop a more intentional way of thinking by
listing things that they are grateful for. It will also deal with signs and symptoms of
anxiety and various lifestyle therapies such as deep breathing, light therapy, exercise, and
avoiding pessimistic thinking to combat depression and anxiety. Improving brain health
through proper nutrition. A whole food, plant-based diet will be encouraged. Intake of
omega-3 fatty acids will recommend as well as enough tryptophan and other vitamins and
minerals from their foods. The person's thinking process on depression and anxiety. The
benefits of cognitive behavioral therapy and correct thinking were presented along with
various remedies for distorted thinking patterns. Addictions will be addressed in the
program. Various addictions that can lead to depression or anxiety will be dealt with, two of
them being alcohol and narcotics. Those with severe alcohol or benzodiazepine addictions will
be encouraged to see a health professional. The common characteristics of addictions with the
need to overcome addictions. The investigators will also deal with principles of cognitive
behavioral therapy strategies, dealing with loneliness and grief, overcoming loss, and
enhancing the frontal lobe function.
An accountability checklist will be used with each participant to complete daily. The
checklist include accounting for water intake, omega-3 fatty acid intake, and proper amount
of exercise, etc. The participants bring the checklist to every session to show that the
tasks in each category were accomplished. The checklist will be utilized to encourage
compliance with the things that were taught .
C 3.c Dietitian led visit This will follow the Academy of Nutrition and Dietetics guidelines
. An individualized plan will be presented to each of the participants. It will last 1 hour
each appointment will follow up appointment of 30 minutes. The focus will be in evaluating
caloric intake, increase physical activity and other behavior changes with the goal of
achieving a 10% weight loss from baseline.
C 3.d Inclusion criteria Age 18+, BMI more than 30 kg/m2, that want to lose weight. Currently
eligible or currently able to receive care at the LAC-DHS a physician willing to adjust their
medications. If patients are taking weight loss medication like orlistat, lorcaserin, and
phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine and benzphetamine
they could enroll if they stop the medication 2 months or more before joining. If they take a
weight loss supplement, they need to stop it 3 months before participating. The investigators
exclude pregnant participants due to the difficulty of tracking their weight. Those with
bariatric surgery will be able to enroll if the surgery was 1 year before joining.
C 3e Recruitment strategy LAC-DHS and its community partners will recruit patients primarily.
There are four medical centers and 19 clinics in LAC-DHS, and many of them have
patient-centered medical homes (PCMH) and other primary care clinics. Among the community
partners is the Southside Coalition of Community Health Centers, which consists of 8 clinics
that can refer patients to LAC-DHS for specialty care, including obesity care. In their
15-20-minute visits, primary care providers in LAC-DHS usually do not have time to address
lifestyle changes for obese patients and may refer them to a dietitian or obesity program
(such as the POWER obesity clinic at MLK OC). With the introduction of eConsults (a DHS-wide
platform that allows PCPs to refer patients to specialists for specialized care, including
obesity treatment), LAC-DHS has improved communication among providers. Within LAC-DHS, there
are about 200,000 obese patients. All primary providers can arrange a remote consultation
with specialists through the eConsult portal, where the obesity clinic and study information
can be found. The DHS Endocrinology Work Group, in which endocrinologists from all the
medical centers meet biweekly to discuss endocrinology issues, is chaired by Dr. Friedman. An
excellent way to disseminate information about the obesity group clinics and the study.
Moreover, word-of-mouth referrals and advocacy from our patients in the obesity program will
also increase. Los Angeles County Department of Health Services provides care to low-income
Medicare beneficiaries (Covered CA) as well as patients without insurance. In ORCHID, visits
are tracked by a "visit charge" that is not charged to patients.
A high percentage of Hispanics and African Americans is expected to participate. Native
Americans, Pacific Islanders, those with substance abuse histories, as well as individuals
with mental illnesses and disabilities may be recruited. Despite their low representation in
the general population, the investigators expect to recruit Caucasians. Covariant analyses
will be conducted on the major ethnic/racial groups.
C.3 Specific Aim 2 study design and approach. The intervention will aim to recruit the 75
participants for the group intervention and 25 participants for 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.
C 3.a Measures For this intervention. The investigators will add 3 tests, in addition to
those tests already given at Power Obesity, to both arms of the study, 9-question Patient
Health Questionnaire (PQ-9), Generalized Anxiety Disorder scale (GAD), and the Depression and
Anxiety Assessment Test, at 0, 3 months, 6 months and 12 months of intervention.
E. Expected outcomes Although it is difficult to predict weight loss, based on our experience
so far, the investigators expect approximately 5% of patients to lose over 10 pounds and
another 10% to lose over 5 pounds during the course of the program. Another 35% should lose
between 2-5% of their weight and the remaining 50% should not lose any weight (although their
education and lifestyle will likely improve). Improved mental health markers are expected, as
well as better International Physical Activity Questionnaire (IPAQ) scores and the healthy
eating index.
Recruiting/consenting goals are realistic. Since LAC-DHS will be recruiting from all parts of
the region, the recruitment goals are quite attainable. With the assistance of two volunteer
students, the investigators recruited 434 patients in 34 months in the past, with Ms. Duran
as the study coordinator dedicating 25% of her time to the project. As a study coordinator,
she will recruit student interns. In terms of recruiting participants and completing the
study, the investigators do not expect to have any difficulties. One of the strengths of our
proposal is the diversity of the participants, but one of its limitations may be the lack of
Caucasians and middle and upper class participants. In our view, this is only a minor
limitation, as most studies under-represent minorities and treatment programs for safety net
clinics must be cost-effective and pragmatic.
F. Sustainability:
Since the resources of LAC-DHS are being used the investigators expect the program to
continue improving and even expand once the program finishes.
One of our main goals is to published multiple studies in order to inspire others to
replicate the model and help many. The investigators plan to do this regardless of the
outcomes.
G. Future direction Our study will end up answering many of our baseline questions and at the
same time it will be creating new questions to be answered in the future. The study has a
potential to be expended with bigger samples and other sites. The results of the study will
determine which direction the study will go.
