Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02011646
Status:
TERMINATED
Last Update Posted:
2016-02-08
First Post:
2013-12-10
Brief Title:
Healthy Body Study
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Testing a Healthy Weight Intervention in Adolescents
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI changed institutions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy averaging 52 hr in duration making implementation difficult and costly The 2010 US Preventative Services Task Force USPSTF recommendations for treating child adolescent obesity state that programs should have 25 hr of comprehensive treatment including dietary physical activity and behavioral counseling and that programs with 25 hr usually do not produce improvements The implication is that if centers cannot provide this level of service as most cannot it is not worth providing any kind of treatment at all In extreme exception to this an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance Healthy Weight has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms as these are prevalent risk factors for obesity We will test the hypothesis that participants assigned to the Healthy Weight vs control intervention will have significantly lower BMI and body fat during follow-up Secondary outcomes will include body dissatisfaction depressive symptoms and eating disorder symptoms 300 adolescents and young adults at high risk for future weight gain by virtue of their age BMI percentile body dissatisfaction and eating disorder symptomatology will be randomized to Healthy Weight or weight control educational video Participants will complete assessments of BMI body composition potential mediators and other outcomes at pretest posttest and 6--mo follow-ups in yr 1 Thus to refute the USPSTF recommendations statement we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders suggesting this inexpensive and brief intervention could and should be rolled out nationwide
Primary Aim To test the hypothesis that Healthy Weight will significantly reduce increases in BMI body fat and risk for onset of obesity during follow-up
Secondary Aim To test the hypothesis that Healthy Weight will significantly reduce body dissatisfaction depressive symptoms and eating disorder symptoms
NOTE THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER
Primary Aim To test the hypothesis that Healthy Weight will significantly reduce increases in BMI body fat and risk for onset of obesity during follow-up
Secondary Aim To test the hypothesis that Healthy Weight will significantly reduce body dissatisfaction depressive symptoms and eating disorder symptoms
NOTE THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER
Detailed Description:
Obesity is associated with increased risk of mortality atherosclerotic cerebrovascular disease coronary heart disease colorectal cancer and death from all causes Flegal et al 2005 is credited with over 111000 deaths annually in the US Flegal et al 2005 shortens the lifespan by 5-20 years Fontaine et al 2003 and results in 150 billion in annual health-related expenditures Finkelstein et al 2009 Despite alarming increases in both adult and childhood obesity in recent decades obesity rates in adolescents have grown at an even faster rate Ogden et al 2012 NCHS 2012 Adolescent obesity has more than tripled in the past 30 years and continues to rise Ogden et al 2012 NCHS 2012 Obese adolescents are more likely to have high cholesterol and high blood pressure prediabetes bonejoint problems sleep apnea and social and psychological problems such as stigmatization and poor self-esteem DHHS 2010 CDC 2011 Unfortunately virtually all obesity treatments result in only transient weight loss Turk et al 2009 Evidence suggests that it is nearly impossible for individuals to maintain behavioral weight losses once they have been obese for an extended period of time Ochner et al 2013 Although bariatric surgery can result in more persistent weight loss this invasive procedure is contraindicated for numerous individuals particularly children Martin et al 2010 Thus a pressing public health priority is to develop simple and effective obesity prevention programs
In 2010 the US Preventive Services Task Force USPSTF issued recommendations for screening and treating childhood and adolescent obesity They endorsed comprehensive moderate-to high intensity programs including counseling for weight loss healthy diet and physical activity as well as instruction and support for the use of behavioral management techniques including self-monitoring stimulus control eating management contingency management and cognitive behavioral therapy techniques The USPSTF further defined moderate- to high-intensity programs as 25 hr of contact and states that such interventions would not be feasible for implementation in a primary care setting USPSTF 2010 p 365 Further they assert that less intensive 25 contact hours programs do not produce significant improvements Low-intensity interventions defined as 25 contact hours over a 6-month period did not result in significant improvement in weight status USPSTF 2010 p 364 The implication is that since most centers cannot provide this level of service it is not worthwhile for adolescent health centers to provide any kind of obesity intervention at all According to the USPSTFs website its recommendations are considered the gold standard for clinical preventive services Such recommendations could discourage the testing and implementation of brief interventions designed to prevent obesity Thus to refute USPSTF statement we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders suggesting that this brief and inexpensive intervention could and should be rolled out nationwide
In 2010 the US Preventive Services Task Force USPSTF issued recommendations for screening and treating childhood and adolescent obesity They endorsed comprehensive moderate-to high intensity programs including counseling for weight loss healthy diet and physical activity as well as instruction and support for the use of behavioral management techniques including self-monitoring stimulus control eating management contingency management and cognitive behavioral therapy techniques The USPSTF further defined moderate- to high-intensity programs as 25 hr of contact and states that such interventions would not be feasible for implementation in a primary care setting USPSTF 2010 p 365 Further they assert that less intensive 25 contact hours programs do not produce significant improvements Low-intensity interventions defined as 25 contact hours over a 6-month period did not result in significant improvement in weight status USPSTF 2010 p 364 The implication is that since most centers cannot provide this level of service it is not worthwhile for adolescent health centers to provide any kind of obesity intervention at all According to the USPSTFs website its recommendations are considered the gold standard for clinical preventive services Such recommendations could discourage the testing and implementation of brief interventions designed to prevent obesity Thus to refute USPSTF statement we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders suggesting that this brief and inexpensive intervention could and should be rolled out nationwide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None