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Heart Obesity Prevention Education (HOPE)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
Tampa General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity

Eligibility Criteria

25 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ketogenic diet

Arm Description

Weight management on a male population of retired NFL athletes.

Outcomes

Primary Outcome Measures

Change in body mass index from start of study in 6 month timeframe.
Calculate change in weight and BMI

Secondary Outcome Measures

Full Information

First Posted
March 13, 2014
Last Updated
December 18, 2014
Sponsor
Tampa General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02092545
Brief Title
Heart Obesity Prevention Education
Acronym
HOPE
Official Title
Heart Obesity Prevention Education: Retired NFL Players Weight Management Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampa General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic diet
Arm Type
Other
Arm Description
Weight management on a male population of retired NFL athletes.
Intervention Type
Other
Intervention Name(s)
Ketogenic diet
Other Intervention Name(s)
High protein, Low carbohydrate
Primary Outcome Measure Information:
Title
Change in body mass index from start of study in 6 month timeframe.
Description
Calculate change in weight and BMI
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Gonzalvo, DO
Organizational Affiliation
Tampa General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

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Heart Obesity Prevention Education

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