Clinical trial NCT02011646: Healthy Body Study
Official title: Testing a Healthy Weight Intervention in Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: diet
body weight
eating
eating disorder
exercise
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: baseline
measure: Body Mass Index (BMI)
timeFrame: at 5 min post intervention
measure: Body Mass Index (BMI)
timeFrame: 6 month follow-up
measure: Body Fat
timeFrame: baseline
measure: Body Fat
timeFrame: at 5 min post intervention
measure: Body Fat
timeFrame: 6 month follow up
Secondary outcomes:
measure: Body Dissatisfaction
timeFrame: baseline
measure: Body Dissatisfaction
timeFrame: at 5 min post intervention
measure: Body Dissatisfaction
timeFrame: at 6 months follow up
measure: Eating Disorders
timeFrame: baseline
measure: Eating Disorders
timeFrame: at 5 min post intervention
measure: Eating Disorders
timeFrame: at 6 months follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christopher Ochner, PhD
role: PRINCIPAL_INVESTIGATOR
References: