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临床试验/NCT05160142
NCT05160142已完成早期 1 期

Diabetes Inspired Culinary Education

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年9月5日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
22
试验地点
2
主要终点
% Change in Hemoglobin A1c

研究概览

简要总结

The aim of this study is to assess the feasibility and efficacy of a community-based culinary nutrition education program (Diabetes Inspired Culinary Education, DICE) on improving the diabetes management and dietary intake of 6-14 year old children with type I diabetes mellitus (TIDM).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Children: 6-14 years old; diagnosed with type I diabetes within the past 5 years; English speaking
  • Adults: primary caregiver of a 6-14 year old child diagnosed with type I diabetes within the past 5 years; English speaking

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Participate in the DICE program, which entails culinary and diabetes educational programming delivered weekly for 10 consecutive weeks.

干预措施: DICE (Behavioral)

结局指标

主要结局

% Change in Hemoglobin A1c

时间窗: Baseline/pretest, 3 months/posttest

Blood glucose/diabetes management

次要结局

  • Change in daily servings of fruit(Baseline/pretest, 3 months/posttest)
  • Change in daily servings of vegetables(Baseline/pretest, 3 months/posttest)
  • Change in daily servings of whole grains(Baseline/pretest, 3 months/posttest)
  • Change in daily servings of sugar-sweetened beverages(Baseline/pretest, 3 months/posttest)
  • Change in daily total caloric intake(Baseline/pretest, 3 months/posttest)
  • Change in primary caregiver body mass index (kg/m2)(Baseline/pretest, 3 months/posttest)
  • Change in child body mass index z-score(Baseline/pretest, 3 months/posttest)
  • Change in child blood pressure z-score(Baseline, 3 months, 6 months, 9 months)
  • Change in child food preparation attitude, self-efficacy and frequency of involvement(Baseline/pretest, 3 months/posttest)
  • Change in child adherence to TIDM management regimen score(Baseline/pretest, 3 months/posttest)
  • Change in child quality of life score(Baseline/pretest, 3 months/posttest)
  • Change in primary caregiver self-efficacy for diabetes management score(Baseline/pretest, 3 months/posttest)
  • Change in primary caregiver self-efficacy for healthy meal planning and eating score(Baseline/pretest, 3 months/posttest)

研究者

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

Catherine Rogers

Assistant Professor

Case Western Reserve University

研究点 (2)

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