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Meal Replacement Study

NCT02355041 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-02-08

No results posted yet for this study

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

Interventions

BEHAVIORAL

Meal Replacement-based Weight Loss Diet

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Christopher Ochner, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-09-30
Completion
2015-09-30

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355041 on ClinicalTrials.gov