A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity (PSMF)
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 11 - 19 |
| Updated: | 4/4/2019 |
| Start Date: | January 1, 2016 |
| End Date: | February 28, 2019 |
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.
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.
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.
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.
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.
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