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

Obesity, Childhood Clinical Trial

— PSMF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899311
• Other study ID #: IRB15-00667
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Aggressive dietary interventions may provide an accessible treatment option for children and adolescents with severe obesity who are not successful with traditional lifestyle behavioral interventions or do not want or qualify for weight loss surgery. One such intensive dietary option is the protein sparing modified fast (PSMF). The PSMF involves minimal carbohydrate intake to induce ketosis, while maintaining adequate or high protein intake to minimize catabolism. The PSMF, under medical supervision, can be an effective and safe intervention for children and adolescents, yet the PSMF diet is not regularly used in the treatment of pediatric severe obesity. This pilot study will employ a prospective cohort study design. Thirty children, 11-19 years-old, with severe obesity, who have been prescribed the rPSMF as part of their treatment in a tertiary care pediatric weight management clinic (PWMC), will be recruited along with their attending parent to participate in the study. The primary aim of the study is to evaluate the acceptability of the rPSMF as assessed by adherence, satisfaction with the intervention, and participation rate using quantitative and qualitative methods. The secondary aim is to investigate the effectiveness of the rPSMF on improving a) anthropometric measures (weight, body mass index [BMI] and BMI z-score); b) metabolic measures (lipid profile, glycosylated hemoglobin, liver function tests); and c) quality of life. Results of this study will provide guidance for the standardization of a pediatric rPSMF protocol in a clinic setting, delineate which factors improve or hinder adherence and weight loss and provide preliminary data for a multicenter randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• non-English speaking

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Obesity, Morbid
• Pediatric Obesity

Intervention

Other:
• protein-sparing modified fast diet
a PSMF diet follow the usual care format in the Center

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ihuoma Eneli

Country where clinical trial is conducted

United States, 

References & Publications (1)

Watowicz RP, Tindall AL, Hummel JC, Eneli IU. The Protein-Sparing Modified Fast for Adolescents With Severe Obesity. Childhood Obesity and Nutrition 7(5): 233-241, 2015.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The acceptability of PSMF diet in a tertiary weight management clinic	The percentage of patients and families recruited over all approached eligible patients, during the recruitment period	Baseline
Primary	The acceptability of PSMF diet in a tertiary weight management clinic	Adherence to the diet tracked by clinical dietitian's notes	12 months
Secondary	Change of body weight between baseline and 12 months among subjects on PSMF	Body weight in kilograms	Baseline and 12 months
Secondary	Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF	BMI in kg/m^2	Baseline and 12 months

External Links

•   The Protein-Sparing Modified Fast for Adolescents With Severe Obesity.