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

This study has been completed.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ) Identifier:
First received: October 20, 2009
Last updated: May 20, 2017
Last verified: May 10, 2017


  • 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.


  • 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.


- 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.


  • 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.

Condition Intervention Phase
Type I Diabetes
Behavioral: Education
Behavioral: Problem Solving
Behavioral: Social Learning
Behavioral: Behavior Modification
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Change in glycemic control, change in dietary intake [ Time Frame: 18 months ]

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

Estimated Enrollment: 321
Study Start Date: September 10, 2009
Study Completion Date: November 27, 2013
Primary Completion Date: November 27, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Behavioral: Education Behavioral: Problem Solving Behavioral: Social Learning Behavioral: Behavior Modification
Active Comparator: Group B Behavioral: Education

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.

Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    1. Child age 8.0-16.9 years
    2. T1D: classical presentation and/or antibody positivity
    3. Diabetes duration greater than or equal to 12 months
    4. Daily insulin dose greater than or equal to 0.5 units/kilogram
    5. Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 9.5%
    6. Insulin regimen

      • a. Greater than or equal to 3 injections daily, OR
      • b. Continuous subcutaneous insulin infusion (insulin pump) (CSII)
    7. Blood glucose monitoring frequency: Greater than or equal to 3 checks daily
    8. Stable living situation (guardian and address) for greater than or equal to 6 months
    9. Joslin Clinic attendance

      • a. At least one Joslin Clinic visit in last year, AND
      • b. Anticipated care at Joslin Clinic for duration of study


  1. Daily use of premixed insulin
  2. Transition to CSII (insulin pump) therapy in last 3 months
  3. Continuous glucose monitoring use in last 3 months
  4. Participation in a different intervention study in the last 6 months
  5. 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:

      • 1. Major psychiatric disorder (e.g., eating disorder, major psychoses), OR
      • 2. Inpatient psychiatric admission during last 6 months
  6. Significant medical or psychiatric illness in caregiver that would prevent active participation in the study
  7. Intent to enroll in another intervention study during the course of this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00999375

United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Tonja R. Nansel, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier: NCT00999375     History of Changes
Other Study ID Numbers: 999909234
Study First Received: October 20, 2009
Last Updated: May 20, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Type 1 Diabetes
Behavioral Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 24, 2017