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临床试验/NCT03899311
NCT03899311已完成不适用

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

Ihuoma Eneli1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
The acceptability of PSMF diet in a tertiary weight management clinic

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
11 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • non-English speaking
  • Patients without adequate social/psychological capacity, as evidenced by unavailability to recourses, or family is unable to provide support.

结局指标

主要结局

The acceptability of PSMF diet in a tertiary weight management clinic

时间窗: 12 months

Adherence to the diet tracked by clinical dietitian's notes

次要结局

  • Change of body weight between baseline and 12 months among subjects on PSMF(Baseline and 12 months)
  • Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF(Baseline and 12 months)

研究者

发起方
Ihuoma Eneli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ihuoma Eneli

Director, Center for Healthy Weight and Nutrition

Nationwide Children's Hospital

研究点 (1)

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