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

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ClinicalTrials.gov Identifier: NCT03899311
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Ihuoma Eneli, 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.

Condition or disease Intervention/treatment
Obesity, Childhood 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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 Name: The PSMF diet




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide Children's Hospital
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899311


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ihuoma Eneli
Investigators
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Principal Investigator: Ihuoma Eneli, MD Nationwide Children's Hospital

Additional Information:
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.

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Responsible Party: Ihuoma Eneli, Director, Center for Healthy Weight and Nutrition, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03899311     History of Changes
Other Study ID Numbers: IRB15-00667
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms