Meal Replacement Study

Obesity Clinical Trial

Official title:

Pilot Meal Replacement-Based Diet Effectiveness Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02355041
• Other study ID #: GCO 14-1212
• Status: Withdrawn
• Phase: Phase 3
• First received: January 30, 2015
• Last updated: February 4, 2016
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Adolescent obesity is associated with a number of serious health conditions and most obese adolescents become obese adults. Despite this fact, very few adolescent health centers offer clinical weight loss programs. This is likely because most weight loss programs require extensive resources and are not covered by most health insurance policies. However, this is expected to change since the American Medical Association's recent decision to recognize obesity as a disease. Therefore, it is important to identify simple and effective nonsurgical programs for weight loss, which can be used in adolescent health centers. The investigators are proposing to show that a meal replacement based diet program will be effective in reducing body mass index (weight adjusted for height). In this pilot study, 90 adolescents will either participate in a meal replacement based weight loss program or watch an educational video. Body mass index and body fat will be recorded over time to see if adolescents participating in the meal replacement program lose more weight than those who do not participate in this program.

In order to address this objective, the investigators will assess group differences in body mass index (BMI; kg/m2), body composition (% body fat), eating disorder symptoms and psychological/behavioral variables.

Description:

Obesity is a risk factor for a number of serious medical comorbidities and is second only to smoking as the leading cause of preventable death in the US. Further, estimates of the costs associated with overweight and obesity have topped $200 billion annually. The numbers are particularly alarming for adolescents, in whom the rate of obesity has risen at 2-3 times as quickly as in adults. Despite the urgent need, very few clinical centers offer obesity treatment due to the resource-intensive nature of most interventions and the fact that behavioral obesity interventions have rarely been reimbursed by 3rd party payers. Following the American Medical Association's recent decision to recognize obesity as a disease and establish ICD-10-CM Diagnosis Codes (e.g., E66.0), however, there is increasing pressure for 3rd party payers to reimburse for effective obesity interventions. Thus, it is critical to identify effective treatment options that can be implemented in medical centers. Prior research has shown meal replacement-based diets to be more effective than typical "lifestyle-change" diet programs, both in terms of weight loss and, more importantly, weight loss maintenance. Evidence also suggests that solid meal replacements (e.g., bars) show greater effectiveness than liquid meal replacements (e.g., shakes). Finally, greater effectiveness is seen with meal replacements that are higher vs. lower in protein. Importantly, these interventions show high rates of effectiveness even in the absence of nutritional counseling, suggesting that a solid meal-replacement based diet program that is relatively high in protein could be highly effective and easily implemented in clinical settings. In this pilot study, 90 adolescents will be randomized to either a meal replacement-based diet (experimental) group or an educational video (comparison) group.

All recruitment and study procedures will take place at the Mount Sinai Adolescent Health Center (MSAHC). The MSAHC is the largest adolescent-specific, integrated, primary care facility in the U.S., and is a unique model that integrates medical, sexual, reproductive, mental health and health education services. MSAHC provides inner-city youth ages 10-24 who are predominately youth of color high quality, comprehensive, easily accessed, free services. Flyers will be posted in the clinic of the Mount Sinai Adolescent Health Center.

At the baseline assessment following recruitment, participants will provide informed consent and complete a structured interview conducted by research staff to more formally assess eating patterns and eating disorders symptomatology. Assessors will conduct interviews at the MSAHC on an individual basis. If a patient meets criteria for an eating disorder, s/he will be referred to treatment. Participants will be randomly assigned to one of two groups using the coin flipper function available at www.random.org. All files will be password protected to prevent unauthorized access of data.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Patient at Mount Sinai Adolescent Health Center

• 18-24 years old

• Obese (BMI at or above the 95th percentile for patients = 20 y.o and BMI = 30 for patients =21 y.o.)

Exclusion Criteria:

• Not a patient at Mount Sinai Adolescent Health Center

• Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder)

• Girls who are pregnant or planning to become pregnant. A participant who becomes pregnant during the study will be terminated from the study.

• Patients with diabetes

• Individuals with active psychiatric or substance use disorders

• Individuals who are allergic to tree nuts, peanuts, milk, eggs, wheat, and sesame.

• Normal weight or overweight patients (< 95th percentile)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Meal Replacement-based Weight Loss Diet

• Educational Video
Via information presented by medical professionals and lifestyle experts, this film delves into issues related to preventing and combating obesity through healthy lifestyle changes. Major topics include the importance of healthy eating and exercise behaviors and the changes that can be made by communities to reshape our lifestyles. Potential community changes are further addressed with respect to schools by presenting particularly successful programs that have been implemented in some schools. Participants will stream it free on the web.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	- Body mass index (BMI; kg/m2). 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.	up to 12 months	No
Secondary	Body Fat as measured by Bioelectrical impedance analysis (BIA)	Bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize sensitivity to predict increases in body fat and obesity onset.	up to 12 months	No
Secondary	Eating Disorder symptoms as measured by the Eating Disorder Diagnostic Scale	The Eating Disorder Diagnostic Scale for screening eating pathology	up to 12 months	No
Secondary	Body Dissatisfaction as measured by an adapted form of the Satisfaction and Dissatisfaction with Body Parts Scale	an adapted form of the Satisfaction and Dissatisfaction with Body Parts Scale to assess body satisfaction. It asks respondents to rate their level of satisfaction with nine body parts on 6-point scales ranging from "extremely satisfied" to "extremely dissatisfied."	up to 12 months	No
Secondary	Depressive symptoms as measured by the 21-item Beck Depression Inventory	The 21-item Beck Depression Inventory to assess depressive symptoms	up to 12 months	No
Secondary	Emotional Eating as measured by the Emotional Eating scale	The Emotional Eating scale from the Dutch Eating Behavior Questionnaire	up to 12 months	No