Healthy Body Study
| Status: | Terminated |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 24 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | September 2015 |
Testing a Healthy Weight Intervention in Adolescents
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
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
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 111,000 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,
bone/joint 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 U.S. 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 USPSTF's 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.
disease, coronary heart disease, colorectal cancer and death from all causes (Flegal et al.,
2005), is credited with over 111,000 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,
bone/joint 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 U.S. 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 USPSTF's 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.
Inclusion Criteria:
- ≥ 12 years old
- Body image concerns
- Sub-threshold Eating disorder symptomatology
- Overweight but not obese (BMI between the 85th and 95th percentile for
children/adolescents and BMI between 25 and 30 kg/m2 for adults 21-24)
- Be able to commit to weekly 1-hour sessions for six weeks and 3 separate assessment
visits to the MSAHC
Exclusion Criteria:
- Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder)
- absence of body image concerns
- normal or obese body weight (< 85th or ≥ 95th BMI percentile)
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