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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: protein-sparing modified fast diet

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide Children's Hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PSMF cohort; The cohort is instructed to follow a protein-sparing modified fast diet and is given standard health care in the Center for Healthy Weight and Nutrition at Nationwide Children's Hospital.	Other: protein-sparing modified fast diet; a PSMF diet follow the usual care format in the Center; Other Names: The PSMF diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The acceptability of PSMF diet in a tertiary weight management clinic	Adherence to the diet tracked by clinical dietitian's notes	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body weight between baseline and 12 months among subjects on PSMF	Body weight in kilograms	Baseline and 12 months
Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF	BMI in kg/m^2	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Ihuoma Eneli

Publications and helpful links

General Publications

• 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.
• Eneli IU, Watowicz RP, Xu J, Tindall A, Walston M, Tanner K, Worthington J, Pratt KJ. Rationale and design of a pilot study to evaluate the acceptability and effectiveness of a revised protein sparing modified fast (rPSMF) for severe obesity in a pediatric tertiary care weight management clinic. Contemp Clin Trials Commun. 2019 May 27;15:100388. doi: 10.1016/j.conctc.2019.100388. eCollection 2019 Sep.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): February 28, 2019
• Study Completion (ACTUAL): February 28, 2019

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: March 31, 2019
• First Posted (ACTUAL): April 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 31, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Obesity, Morbid
• Other Study ID Numbers: IRB15-00667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No