Healthy Body Study

NCT02011646 | Terminated

• 1 other identifier: GCO 13-0765
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

diet; body weight; eating; eating disorder; exercise

Outcome Measures

Primary Outcomes (6)

• Body Mass Index (BMI)

  Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.

  baseline

• Body Mass Index (BMI)

  Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.

  at 5 min post intervention

• Body Mass Index (BMI)

  Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.

  6 month follow-up

• Body Fat

  Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.

  baseline

• Body Fat

  Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.

  at 5 min post intervention

• Body Fat

  Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.

  6 month follow up

Secondary Outcomes (6)

• Body Dissatisfaction

  baseline

• Body Dissatisfaction

  at 5 min post intervention

• Body Dissatisfaction

  at 6 months follow up

• Eating Disorders

  baseline

• Eating Disorders

  at 5 min post intervention

Study Arms (2)

Healthy Weight

EXPERIMENTAL

intervention four times per week and consist of approximately 10 participants.

Behavioral: Healthy Weight

Controlled Intervention

ACTIVE COMPARATOR

Participants will be given a copy of the DVD. They will also be given the choice to stream it free on the web.

Behavioral: Controlled Intervention

Interventions

Healthy Weight BEHAVIORAL

The PI will train 4 group leaders to deliver the intervention. Groups will be offered four times per week and consist of approximately 10 participants. Each group will be led by 2 group leaders and each group leader will lead two sessions per week during the 2.5 mo intervention period. Group leaders will digitally video-record all sessions of the first two groups they deliver so the PI can provide supervision and rate fidelity and competence for a random selection of 6 of these 12 sessions. Group leaders will transmit the video recordings via an encrypted, secure internet connection to Dr. Ochner (who was trained by Dr. Eric Stice, the creator of the intervention) within 3 d for supervision, and competence and fidelity assessments.

Healthy Weight

Controlled Intervention BEHAVIORAL

"The Weight of the World" is a 51 min documentary focusing on the topics of obesity and healthy living. Via information presented by medical professionals and lifestyle experts, this film delves into issues related to preventing and combating obesity. Major topics include the importance of healthy eating and exercise behaviors and the changes that can be made by communities to reshape our lifestyles. Participants will be given a copy of the DVD. They will also be given the choice to stream it free on the web.

Controlled Intervention

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Obesity; Body Weight; Feeding and Eating Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Behavior

Study Officials

• Christopher Ochner, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

US (1)