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临床试验/NCT00999375
NCT00999375已完成2 期

Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2009年9月18日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
293
试验地点
1
主要终点
Change in glycemic control, change in dietary intake

研究概览

简要总结

Background:

  • Type 1 diabetes (T1D) is a common chronic disease in children, occurring in approximately 1 of every 400 to 600 children. Children with T1D are unable to produce insulin, a hormone that allows the body to use glucose from food. Children with T1D manage their diabetes by taking insulin, monitoring their blood glucose levels, and watching their diet, including carbohydrates.
  • Carbohydrates come from many different kinds of food, and recent research has shown that different foods have a different effect on the level of glucose in the blood. In general, whole, unprocessed foods (e.g., fruits, vegetables, whole grains, legumes) have a lower glycemic index (GI), which means that they cause smaller, more sustained blood sugar levels. Additionally, these foods are rich in nutrients. Nutrient-poor carbohydrates come from foods made with refined grains and sugars, such as breads, crackers, and breakfast cereals; they general cause a more rapid increases in blood sugar (i.e., a high GI). Lower GI diets may help people with T1D manage their blood glucose levels more easily.

Objectives:

  • To determine the utility of a whole foods, low GI diet in the management of T1D.
  • To determine the utility of a behavioral intervention to promote healthful family dietary behaviors, including eating more fruits, vegetables, whole grains, and legumes, and fewer refined carbohydrates.
  • To determine how the dietary intervention affects quality of life, satisfaction with the diet, and risk for problem eating behaviors.

Eligibility:

  • Children 8 to 16 years of age who have been diagnosed with T1D for more than 12 months, and who use insulin injections to maintain normal blood glucose levels.

Design:

  • Families will be divided into two groups: an intervention group that will participate in intensive dietary intervention and continuous glucose monitoring (CGM) and a control group that will not have the dietary intervention but will have CGM and scheduled contacts with study staff.
  • Intervention group families will have 11 family-based and 2 group-based sessions consisting of behavioral techniques and educational content about eating nutrient-dense, low GI foods. CGM results will give families feedback about how their diet affects blood glucose levels. At least one parent and the child with T1D will participate in the intervention.
  • Intervention topics will consist of goal setting, behavior self-monitoring, educational information, and problem solving, among others. Parents and children will record the foods they eat.
  • Control group families will participate in 11 family-based sessions consisting of CGM feedback.
  • Assessments will be conducted at 6, 12, and 18 months, and medical record information, including blood and urine testing, will be obtained at each routine clinic visit.

详细描述

This protocol describes a randomized controlled trial to promote consumption of carbohydrates from nutrient-dense whole foods among children and adolescents with type 1 diabetes and to determine the efficacy of such dietary changes in improving glycemic control and other diabetes-related health outcomes.

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
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • Child age 8.0-16.9 years
  • T1D: classical presentation and/or antibody positivity
  • Diabetes duration greater than or equal to 12 months
  • Daily insulin dose greater than or equal to 0.5 units/kilogram
  • Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 9.5%
  • Insulin regimen
  • a. Greater than or equal to 3 injections daily, OR
  • b. Continuous subcutaneous insulin infusion (insulin pump) (CSII)
  • Blood glucose monitoring frequency: Greater than or equal to 3 checks daily
  • Stable living situation (guardian and address) for greater than or equal to 6 months
  • Joslin Clinic attendance
  • a. At least one Joslin Clinic visit in last year, AND
  • b. Anticipated care at Joslin Clinic for duration of study

排除标准

  • Daily use of premixed insulin
  • Transition to CSII (insulin pump) therapy in last 3 months
  • Continuous glucose monitoring use in last 3 months
  • Participation in a different intervention study in the last 6 months
  • Presence of co-morbid conditions (any of the following):
  • a. Celiac disease, inflammatory bowel disease, or other significant gastrointestinal condition
  • b. Systemic glucocorticoid use (cumulative 1 month during last year)
  • c. Significant multiple food allergies
  • d. Significant mental illness defined by either:
  • Major psychiatric disorder (e.g., eating disorder, major psychoses), OR
  • Inpatient psychiatric admission during last 6 months
  • Significant medical or psychiatric illness in caregiver that would prevent active participation in the study
  • Intent to enroll in another intervention study during the course of this study

结局指标

主要结局

Change in glycemic control, change in dietary intake

时间窗: 18 months

次要结局

  • Change in social cognitive mediators of behavior; change in psychosocial status; change in body composition, lipids, oxidative stress, and inflammation

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Sponsor

研究点 (1)

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