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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00999375
First received: October 20, 2009
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

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 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Behavioral: Education
N/A
Device: CGM
Continuous Glucose Monitoring
Behavioral: Problem Solving
N/A
Behavioral: Social Learning
N/A
Behavioral: Behavior Modification
N/A
Active Comparator: Group B Device: CGM
Continuous Glucose Monitoring

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    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

EXCLUSION CRITERIA:

  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 ClinicalTrials.gov identifier: NCT00999375

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

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier: NCT00999375     History of Changes
Other Study ID Numbers: 999909234, 09-CH-N234
Study First Received: October 20, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014