A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity (PSMF)

Completed

Conditions studied: Obesity, Childhood

In brief

This is a 12 month prospective observational cohort study of the outpatient protein-sparing modified fast diet for children with severe obesity and serious comorbid condition(s). The study will enroll 30 Center for Healthy Weight and Nutrition patients aged 11-19 years who have been placed on a protein sparing modified fast as part of their treatment plan. The study-specific procedures consist of questionnaires/interviews on diet and PA behaviors, adherence and self-efficacy measures, data abstraction from the chart and tracking of activity using a Fitbit.

Key facts

Study ID

NCT03899311

Run by

Ihuoma Eneli

People needed

30

Starts

2016-01-01

Expected to finish

2019-02-28

Last updated by the study team

2019-04-02

Who can join

Age: 11 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children Age 11-19 years old
• Must be severely obese (BMI greater than or equal to 120% of the 95th percentile for their age and sex, or a BMI of 35 or greater)
• Must have at least one severe comorbidity
• Tanner Stage III, IV, V

You may not qualify if…

• non-English speaking
• Patients without adequate social/psychological capacity, as evidenced by unavailability to recourses, or family is unable to provide support.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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