Meal Replacement Study

NCT02355041 | Withdrawn Phase 3

• 1 other identifier: GCO 14-1212
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Keywords

diet; body weight; eating; meal replacement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Body Fat as measured by Bioelectrical impedance analysis (BIA)

  up to 12 months

• Eating Disorder symptoms as measured by the Eating Disorder Diagnostic Scale

  up to 12 months

• Body Dissatisfaction as measured by an adapted form of the Satisfaction and Dissatisfaction with Body Parts Scale

  up to 12 months

• Depressive symptoms as measured by the 21-item Beck Depression Inventory

  up to 12 months

• Emotional Eating as measured by the Emotional Eating scale

  up to 12 months

Study Arms (2)

Meal Replacement-based Weight Loss Diet

EXPERIMENTAL

Experimental participants will be instructed to replace 2 meals per day with a PROBAR meal replacement and consume a dinner under 1000 calories or a dinner under 800 calories and a 200 calorie snack for 90 days. No further nutritional advice or education shall be provided.

Behavioral: Meal Replacement-based Weight Loss Diet

Educational Video

ACTIVE COMPARATOR

Control participants will view "The Weight of the World," 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 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.

Behavioral: Educational Video

Interventions

Meal Replacement-based Weight Loss Diet BEHAVIORAL

Meal Replacement-based Weight Loss Diet

Educational Video BEHAVIORAL

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.

Educational Video

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient at Mount Sinai Adolescent Health Center
• years old
• Obese (BMI at or above the 95th percentile for patients ≤ 20 y.o and BMI ≥ 30 for patients ≥21 y.o.)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Ochner, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02