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临床试验/NCT05720377
NCT05720377撤回不适用

Evaluation of Exercise Application Technology and Continuous Glucose Monitoring to Improve Weight Loss and Metabolic Markers in Adolescents

University of Alabama at Birmingham0 个研究点开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
skin fold thickness

研究概览

简要总结

The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.

详细描述

Patients will be recruited directly from the Childrens of Alabama pediatric endocrine clinic. Thirty patients who have obesity, prediabetes or Type 2 diabetes will be enrolled. During the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. Our study team will approach interested participants during their routine clinic visit. Consent will be obtained by study team during their endocrine clinic visit. Review of their medical records will be done and age, gender and race will be extracted from the medical record. A baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. Once enrolled, the patients will then be randomized.Within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or Type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. The randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and Type 2 diabetes.

Those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. Follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw.

Intervention Group

Access provided to exercise application Provided with Fitbit to wear and measure activity Weekly check-in with provider to determine how exercise goals have been that week. If unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week.

Meeting with nutrition at Baseline visit

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • for Type 2 diabetes arm
  • BMI > 95th percentile
  • A1c> 6.5%
  • Age 14-17 (2 years post-menarchal)
  • Inclusion for Prediabetes Arm
  • Age 14-17 (2 years post-menarchal)
  • A1c 5.7-6.4%
  • Inclusion for Obesity Arm
  • Age 14-17 (2 years post-menarchal)
  • A1c 5.7-6.4%

排除标准

  • for all arms
  • BMI <95th percentile
  • Specific obesity syndrome
  • Inability to participate in exercise workouts

研究组 & 干预措施

Type 2 diabetes, receives access to exercise phone application

Experimental

prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor

干预措施: continuous glucose monitor (Freestyle Libre (Device)

Type 2 diabetes, no intervention

No Intervention

Type 2 diabetes, receives continuous glucose monitor

Prediabetes, no intervention

No Intervention

prediabetes, receives continuous glucose monitor

Obese, receives access to exercise phone application

Experimental

obese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor

干预措施: continuous glucose monitor (Freestyle Libre (Device)

Prediabetes, receives access to exercise phone application

Experimental

prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor

干预措施: continuous glucose monitor (Freestyle Libre (Device)

Obese, no intervention

No Intervention

obese, receives continuous glucose monitor

结局指标

主要结局

skin fold thickness

时间窗: baseline

reliable estimate of subcutaneous fat at various sites of the body

skin fold measurement

时间窗: 6 month

reliable estimate of subcutaneous fat at various sites of the body

Body mass index

时间窗: 3 month

measure of body fat based on height and weight

Body Mass Index

时间窗: 6 month

measure of body fat based on height and weight

次要结局

  • TNF-alpha(6 months)
  • IL-6(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christy Foster

Assistant Professor

University of Alabama at Birmingham

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