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

November 27, 2019 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

293

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Behavioral: Education
Behavioral: Problem Solving
Behavioral: Social Learning
Behavioral: Behavior Modification
Active Comparator: Group B
Behavioral: Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glycemic control, change in dietary intake
Time Frame: 18 months
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 18, 2009

Primary Completion (Actual)

November 27, 2013

Study Completion (Actual)

November 27, 2013

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

October 30, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999909234
  • 09-CH-N234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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