Clinical trial NCT03899311: A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity (PSMF)
Official title: A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Childhood
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide Children's Hospital

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The acceptability of PSMF diet in a tertiary weight management clinic
timeFrame: Baseline
measure: The acceptability of PSMF diet in a tertiary weight management clinic
timeFrame: 12 months
Secondary outcomes:
measure: Change of body weight between baseline and 12 months among subjects on PSMF
timeFrame: Baseline and 12 months
measure: Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Ihuoma Eneli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.