What Clinical Trials for Weight Loss Surgery in the USA are Available?
Weight loss is considered to be one of the most complex topics in human biology.
Medical research on weight loss is focused on many aspects of this complicated process.
There have been thousands of research studies done on the topic to date and thousands more continue.
As obesity and overweight become increasingly prevalent in society, researchers and health experts are trying to figure out how the body signals hunger and how it stores fat in addition to how these processes can be manipulated for a healthier body.
Other researchers are busy identifying the neurological aspects of human behavior that lead to obesity and the role hormones play in regulating the body’s weight.
Need for additional clinical trials for weight loss surgery
In the last few decades, a noticeable number of medical studies have focused on metabolic factors that result in weight gain.
Clinical trials for weight loss are incredibly essential to understand how metabolism restricts weight loss in teens, adolescents and adults.
They are also focused on identifying the concurring conditions that arise from being overweight.
Clinical trials can be performed to test new drugs or medical devices.
In addition, clinical trials are also held to test new techniques of diagnosing conditions as well as to test the effectiveness of new health intervention techniques for treating specific disorders.
Clinical trials for weight loss also focus highly on diet and nutrition to understand the role of nutrients in our health.
This approach is extremely essential to learn how food can be used as treatment and as a preventive measure against weight gain.
Clinical trials are performed within strict protocols and need to be approved by the FDA, internal review boards and other relevant agencies, all to ensure that clinical trials for weight loss are managed safely and ethically.
Why should you choose to volunteer for clinical trials for weight loss surgery?
Clinical trials are extremely essential parts of clinical research. These form the core of medical science and help in its advancement.
Clinical trials for obesity are aimed at finding new and more effective ways to identify, treat and prevent obesity.
These trials focus on the effects of diet, dietary habits, novel behavior and finding medication, devices and surgical techniques to combat obesity.
These trials give doctors a better understanding of the reasons why people develop obesity and how individuals respond to different weight loss treatments.
Some of the main reasons that people choose to undergo clinical trials for weight loss surgery are to help scientists and doctors:
- Find out how specific patients respond to particular types of diet or drug
- Learn the functions of the bacteria in the gastrointestinal tract and how it affects the risk of obesity in a person
- Observe the way metabolism affects obesity and other consequent health conditions that arise from obesity
- Figure out how weight gain during pregnancy can affect the health of the child and mother
- Discover the effect of physical activity in decreasing obesity and maintaining an overall good health
How to join clinical trials for weight loss surgery?
Clinical trials are completely voluntary. So, you can participate or withdraw from the trial at any point in time.
When you decide to participate in a clinical trial you will need to sign an informed consent document to indicate your agreement to participate in the clinical trial.
However, this consent form does not bind you to participate in the entire trial and you can opt-out of the trial at any given time without any consequences.
Let’s take a detailed look at some of the top clinical trials for weight loss surgery that you can choose to volunteer at:
1 – Novel Executive Function Training for Obesity (NEXT)
Study Description
This study aims to assist with treatment development using two groups of around 10 volunteers in a 12-week long open-label treatment of NEXT.
The participants will be provided qualitative feedback to help develop improved obesity treatments. After this, a randomized control trial will determine the effectiveness of NEXT as compared to conventional BWL.
This study is aimed at determining the feasibility, acceptability and preliminary efficacy of the new anti-obesity treatment method.
Novel Executive Function Training for Obesity (NEXT)
Study Design
- Official Title – Novel Executive Function Training for Obesity
- Study Type – Interventional (Clinical Trial)
- Estimated Enrollment – 64 participants
- Allocation – Randomized
- Interventional Model – Parallel Assignment
- Masking – Single (Outcome Assessor)
- Primary Purpose – Treatment
- Recruitment Status – Recruiting
Eligibility Criteria
(Inclusion Criteria)
- Age between 18 to 65 years old
- Should be able to read English at the 6th-grade level
- BMI should be between 25 and 45
- Should have difficulty with executive functioning
(Exclusion Criteria)
- The existing medical condition that needs physician monitoring to participate in weight control program or prevents safe participation in required physical activities
- Having psychiatric conditions that may hinder participation in the clinical trials, such as suicide attempts within the last 6 months, substance abuse, active purging, etc.
- Being pregnant, nursing or planning to be pregnant during the clinical trial period
- Being already a part of another weight control clinical trial
- History of weight loss (bariatric) surgery
- Having learning disabilities or neurological condition or injury
Contacts
- Ellen Pasquale, BS – 858-380-5579 ( [email protected] )
- Dawn Eichan, Ph.D. – 858-534-8322 ( [email protected] )
Location
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States, 92093
2 – Targeting the Gut-Brain Axis to Facilitate Weight Loss in High Fat Diet Consumers
Study Description
This clinical trial aims to take a precision medicine approach to obesity treatments, specifically on weight loss maintenance.
This study proposes to optimize a stratification strategy with the help of neural, metabolic and behavioral measures.
This will help identify participants who can maintain noticeable weight loss by daily supplements of fatty acid amide, oleoyl ethanolamide (OEA) after undergoing a gold-standard weight loss program.
Study Design
- Official Title – Targeting the Gut-brain Axis to Facilitate Weight Loss in High Fat Diet Consumers
- Study Type – Interventional (Clinical Trial)
- Estimated Enrollment – 120 participants
- Allocation – Randomized
- Intervention Model – Parallel Assignment
- Masking – Quadruple (Participant, Care Provider, Outcome Assessor, Investigator)
- Primary Purpose – Treatment
- Recruitment Status – Recruiting
Eligibility Criteria
(Inclusion Criteria)
- Ages between 18 and 45 years old
- English-speaking
- Right-handed with a score of /= +50 on the modified Edinburgh handedness scale
- BMI of less than 25
- At ease with fMRI procedures during mock scanning sessions
- Find milkshake at least mildly likable
(Exclusion Criteria)
- Severe or unstable medical disease (such as cancer)
- Consistent drug or alcohol use currently or in the recent past
- Diagnosed with major psychiatric illness (according to DSM-IV criteria) alongside an eating disorder
- On medications that cause alertness, such as phenytoin, lithium, chloral hydrate, etc.
- Currently pregnant
- Past head injury with loss of consciousness
- Pacemaker or neurotransmitter implanted
- Past injury during metal-working, such as injury from metal slivers and shrapnel or major surgery
- Diagnosed diabetic
- Diagnosed with a malfunctioning sense of taste or smell
- Known to have a food allergy
- Regular smoker or tobacco user
Contacts
- Dana Small, Ph.D. – 1(203) 401-6242 ( [email protected] )
- Xu Davis, Ph.D. – 717-579-9220 ( [email protected] )
Location
Connecticut, USA
3 – Improving Nutritional Choices in Adolescents (LIITA3H)
Study Description
The epidemic of childhood obesity is caused by exposure to, and consumption of, fast food (calorie-dense food items) which are prepared outside of the home.
Previous studies show that, as compared to their peers, African-American youth tend to live in communities with a higher density of fast feed restaurants.
An intervention can help these adolescents make healthy food choices.
Thus, the Location Initiated Individualized Texts for African-American Adolescent Health (LIITA3H) mobile application was developed.
Earlier research unveiled the fact that adolescents welcome health-related text messages if they are deemed as personally relevant, especially when they receive this while facing dietary choices, such as at a restaurant.
Study Design
- Official Title – Location Initiated Individualized Texts for African American Adolescent Health
- Study Type – Interventional (Clinical Trial)
- Estimated Enrollment – 150 participants
- Allocation – Randomized
- Intervention Model – Parallel Assignment
- Masking – Single (Outcomes Assessor)
- Primary Purpose – Other
- Recruitment Status – Recruiting
Eligibility Criteria
(Inclusion Criteria)
- Identifies self as African American
- Eats at fast-food restaurants at least 3 times a week on an average
- Has BMI at, or above, 85th percentile
(Exclusion Criteria)
NONE
Contacts
- Susan J. Woolford, MD – 7349041455 ( [email protected] )
- Theresa Kowalski-Dobson, MPH – (734) 232-2455 ( [email protected] )
Location
The University of Michigan,
Ann Arbor, Michigan,
The United States, 48109
4 – Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY)
Study Description
To prevent weight gain, it is recommended that an intervention that promotes self-weighing be tried.
This intervention will not advise changing diet, increasing physical activity or attending didactic-centric meetings.
Empirical research and self-regulatory theory support the potential of self-weighing as a means of better weight management.
This technique will enhance participants’ self-regulatory skills and help make decisions that eventually but effectively decrease calorie intake or increase physical activity to prevent weight gain.
Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY)
This proposed intervention technique will employ text message-based feedback to promote regular self-weighing and to motivate them to use all available resources.
Study Design
- Official Title – Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment
- Study Type – Interventional (Clinical Trial)
- Estimated Enrollment – 40 participants
- Allocation – N/A
- Intervention Model – Single Group Assignment
- Intervention Model Description – Single-Arm Trial
- Masking – None (Open Label)
- Primary Purpose – Prevention
- Recruitment Status – Recruiting
Eligibility Criteria
(Inclusion Criteria)
- Aged between 18 and 70 years
- Weight /= 375 lb.
- Bodyweight recorded in HER in the previous month at a primary healthcare center
- Last BMI in HER is either /= 30 kg/m², or between 25 and 29.9 kg/m², with diagnosed weight-related co-morbidities, such as type-II diabetes, hypertension, pre-diabetes, sleep apnea, etc.)
- Not currently part of any behavioral weight loss treatment
- Self-report receiving and sending at least 1 text message every month for the past 6 months
- Has not self-weighed /= 5 times a week on an average in the previous month
- Does not plan to enroll in any comprehensive weight loss programs in the next month
- Not pregnant, breast-feeding or planning to get pregnant in the next 6 months
- Has no history of eating disorders
- Is not undergoing chemotherapy or radiation treatment for cancer
- Interested in participating in a low-burden, self-weighing intervention
- Able to read, speak and understand common English
(Exclusion Criteria)
- Has suffered Congestive Heart Failure/Heart Attack in the past 6 months
- Planning to move to another region in the next 12 months
- Answering incorrectly on any validation survey/attention check item
Contacts
- Melinda Rajoria – 352-294-1815 ( [email protected] )
- Megan McVay, Ph.D. – 352-294-1638 ( [email protected] )
Location
UF Health at the University of Florida,
Gainesville, Florida, United States, 32610
5 – Social Mobile Approaches to Reducing weight in Young Adults (SMART 2)
Study Description
The period of transition of young adults from adolescence to early adulthood has multiple stressors that result in weight gain.
Being overweight raises the risk of heart disorders, diabetes and other health problems.
Hence, there is a crucial need to enhance our knowledge of how to develop and deploy high-tech, multi-model weight-loss interventions that can potentially have positive long-term effects.
The SMART 2.0 study is designed to determine the effectiveness of interventions on objectively measured weight in kilograms throughout the trial.
Study Design
- Official Title – SMART 2.0: Social Mobile Approaches to Reducing weight in Young Adults
- Study Type – Interventional (Clinical Trial)
- Estimated Enrollment – 642 participants
- Allocation – Randomized
- Intervention Model – Parallel Assignment
- Intervention Model Description – 24-month, parallel-group, randomized controlled trial
- Masking – Double (Investigator, Outcomes Assessor)
- Primary Purpose – Treatment
- Recruitment Status – Recruiting
Eligibility Criteria
(Inclusion Criteria)
- Aged between 18 to 35 years
- Available for 24 months-long intervention trial
- Student, faculty or staff from either San Diego State University (SDSU), University of California, San Diego (UCSD) or California State University, San Marcos (CSUSM)
- Willing, a regular user of social media
- Willing and regular user of a smartphone and sends/receives text messages regularly
- Willing and regular user of wearable, scale and corresponding app
- Willing and available to attend measurement visits regularly for the 24-month intervention
- Willing and regularly participating in moderate physical activity
- Overweight/obese with BMI 25 to 40 kg/m²
(Exclusion Criteria)
- Any clinically-referred co-morbidities, such as eating disorders, orthopedic problems, pseudotumor cerebri, sleep apnea/hypoventilation syndrome or diagnosed diabetes
- Suffering from psychiatric or medical conditions that restrict complying with protocols of the clinical trial
- History of cardiovascular events, such as temporary heart failure, heart attack or revascularization procedure) in the past 6 months
- Presently undergoing treatment for a malignant type of cancer (non-melanoma skin cancer, etc.)
- Currently suffering from, or being treated for, eating disorders
- Planning to undergo surgical weight loss treatment in the next 24 months, such as lap band, gastric bypass, liposuction, etc.)
- Presently pregnant, given birth within last 6 months, currently breastfeeding or lactating with the last 3 months, or actively planning to get pregnant within the next 24 months
- Dietary or physical activity changes have been prescribed
- Taking medication for weight loss
- Presently participating, or planning to participate in, a weight loss program within the duration of the study
- Have lost over 15 lb. in the last 3 months
Contacts
- Shadia J. Assi, MPH – 8582463302 ( [email protected] )
- Victoria M. Costello, MPH – 8582465866 ( [email protected] )
Location
The University of California,
La Jolla, San Diego,
California, United States, 92093
Conclusion
Clinical trials for weight loss surgery are incredibly crucial to enhance the current weight management procedures.
Participating in a clinical trial for obesity can help you to gain in-depth knowledge of your condition and help you to lose weight with increased effectiveness.
Now clinical trials are not the only way to get assistance for weight loss surgery. You can always apply for grants for weight loss surgery if you are qualified.
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