Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
Condition: Type I Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Education; Problem Solving; Social Learning; Behavior Modification
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Diet; Behavioral Intervention; Children; Adolescents