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NCT Number: NCT03899311

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

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

protein-sparing modified fast diet

Other

a PSMF diet follow the usual care format in the Center

Other names: The PSMF diet

Primary outcomes

  1. The acceptability of PSMF diet in a tertiary weight management clinic

    Time frame: Baseline

    The percentage of patients and families recruited over all approached eligible patients, during the recruitment period

  2. The acceptability of PSMF diet in a tertiary weight management clinic

    Time frame: 12 months

    Adherence to the diet tracked by clinical dietitian's notes

Secondary outcomes

  1. Change of body weight between baseline and 12 months among subjects on PSMF

    Time frame: Baseline and 12 months

    Body weight in kilograms

  2. Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF

    Time frame: Baseline and 12 months

    BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Ihuoma Eneli

Other

Registry information

Official study title

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

Acronym: PSMF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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