ObesityHOPENCT02092545
Heart Obesity Prevention Education
A study testing Ketogenic diet in people with Obesity, run by Tampa General Hospital at 1 site in United States.
Trial summary
Study to collect data on weight management on a male population of retired NFL athletes. Read more about this study
- Who is it for?
- Ages 25 to 64 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males
- Former NFL players
- Aged 25-64 (Age range is chosen to keep participants as uniform as possible given the small number of participants. The majority of the players are in this age range and participants need to be able to exercise and be active. Also the NFL in its current form was created in 1970 so there are very few players that are retired from the NFL that are over the age of 65.)
- BMI >27
- English- speaking
Who cannot join
- Cancer within the last 5 years (except non-melanoma skin cancer)
- Significant Cardiovascular Disease (recent < 1 year Myocardial Infarction, hospital admission < 1year for Congestive Heart Failure, Active Angina, exercise induced Angina)
- Malignant arrhythmias (VTACH, AFIB, Aflutter)
- Renal Disease ( Dialysis or Chronic Renal Insufficiency)
- Hepatic Disease ( Hepatitis B and C or Liver function test 2.5 times the upper limits of normal, or liver transplant that requires immune odulating/suppressing medications, ammonia lowering medications, or hepatic disease related to diet modification).
- Psychosis, Severe Anxiety, or Major Depression
Show all 32Show fewer
- Significant migraines requiring abortive medication in the last year
- Significant Endocrine dysfunction ( Cushing's Syndrome )
- Uncontrolled Hypertension > 160/90
- Severe arthritis that significantly limits mobility
- Uncontrolled Hyper/Hypothyroidism
- Obesity Surgery in the past
- Weight loss of greater than 10% of the subjects body weight in the last year
- Recent history (within 1 year ) of Alcohol abuse, illegal Drug abuse
- Active pulmonary disease that requires daily corticosteroids, an oxygen requirement, or ventilation support for chronic disease management.
- Participants currently taking or having been taking within the last 3 months the following medication will be excluded.
- Appetite Suppressants (Phenterimine, Qsymia)
- Anti-obesity medications (Xenical/Meridia)
- Corticosteroids or > 1500 micrograms of inhaled steroids daily
- Raloxifene (Evista) or Temoxifene (HRT medications)
- Inappropriate use of Testosterone
- At the discretion of the investigator use of Psychiatric Medication, Sedative/Hypnotics, Benzodiazepines
- Detailed Disease and Lab Value Exclusion
- Active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (>2 weeks) immune modulating/suppressing medications.
- Active renal disease will be defined as any patient who is currently, or has a history requiring potassium phosphate lowering medication, protein restriction diet, or hemo/peritoneal dialysis
- Screening creatinine >1.5
- Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Participants with screening triglycerides above 500 mg.
- Uncontrolled Dyslipidemia as defined by screening LDL cholesterol >160 mg/dL. Participants on medication treating dyslipidemia for at least 3 months are allowable.
- Neuropathy that interferes with exercise.
- Previous weight loss surgery
- Lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Obesity Prevention Education: Retired NFL Players Weight Management Study
Study to collect data on weight management on a male population of retired NFL athletes.
Read the detailed description
Up to ten retired NFL players will receive a comprehensive and monitored weight loss program using a protocol that has been established at the TGH+USF Bariatric Center. A low calorie diet with meal replacements will be used and over the course of the study the participants will be taught to eat low calorie nutritious foods. The sessions will teach proper eating habits, stress control, and skills to maintain a healthy weight.
The length of the study is 6 months. Treatment will last 24 weeks, the participants will attend group sessions (60-90 mins.) on a weekly basis for weeks 1-12 and then every other week for weeks 14-24, for a total of 18 treatments. Treatment will include meal replacement, education on nutrition and proper eating habits as well as behavior modification and skills which is known to be effective.
Participants will be scheduled to come to the Bariatric Center for the first assessment/screening and for the consenting process. TGH+USF Bariatric Center has dedicated clinical space in their suite with private exam rooms, an education classroom, and private testing room.
- Conditions
- Obesity
- Being tested
- Ketogenic diet
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
Also called High protein, Low carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Other | Weight management on a male population of retired NFL athletes. Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index from start of study in 6 month timeframe.
Calculate change in weight and BMI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Gonzalvo, DO, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092545
- Sponsor's protocol ID
- TGH0002
- Acronym
- HOPE
- Status last verified
- Dec 2014
- First submitted
- 13 Mar 2014
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Obesity Prevention Education: Retired NFL Players Weight Management Study
- ClinicalTrials.gov ID
- NCT02092545
- Acronym / sponsor ID
- HOPE / TGH0002
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to collect data on weight management on a male population of retired NFL athletes.
Detailed description
Up to ten retired NFL players will receive a comprehensive and monitored weight loss program using a protocol that has been established at the TGH+USF Bariatric Center. A low calorie diet with meal replacements will be used and over the course of the study the participants will be taught to eat low calorie nutritious foods. The sessions will teach proper eating habits, stress control, and skills to maintain a healthy weight.
The length of the study is 6 months. Treatment will last 24 weeks, the participants will attend group sessions (60-90 mins.) on a weekly basis for weeks 1-12 and then every other week for weeks 14-24, for a total of 18 treatments. Treatment will include meal replacement, education on nutrition and proper eating habits as well as behavior modification and skills which is known to be effective.
Participants will be scheduled to come to the Bariatric Center for the first assessment/screening and for the consenting process. TGH+USF Bariatric Center has dedicated clinical space in their suite with private exam rooms, an education classroom, and private testing room.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Other | Other: Ketogenic dietWeight management on a male population of retired NFL athletes. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males
- Former NFL players
- Aged 25-64 (Age range is chosen to keep participants as uniform as possible given the small number of participants. The majority of the players are in this age range and participants need to be able to exercise and be active. Also the NFL in its current form was created in 1970 so there are very few players that are retired from the NFL that are over the age of 65.)
- BMI >27
- English- speaking
Key exclusion criteria (32 listed)
- Cancer within the last 5 years (except non-melanoma skin cancer)
- Significant Cardiovascular Disease (recent < 1 year Myocardial Infarction, hospital admission < 1year for Congestive Heart Failure, Active Angina, exercise induced Angina)
- Malignant arrhythmias (VTACH, AFIB, Aflutter)
- Renal Disease ( Dialysis or Chronic Renal Insufficiency)
- Hepatic Disease ( Hepatitis B and C or Liver function test 2.5 times the upper limits of normal, or liver transplant that requires immune odulating/suppressing medications, ammonia lowering medications, or hepatic disease related to diet modification).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietAlso: High protein, Low carbohydrate | Other | Ketogenic diet |
Primary outcome
Change in body mass index from start of study in 6 month timeframe.
Time frame: 6 months
Calculate change in weight and BMI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gonzalvo, DO principal investigator
Tampa General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Obesity, run by Tampa General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index from start of study in 6 month timeframe. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.