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

Type I Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999375
• Other study ID #: 999909234
• Secondary ID: 09-CH-N234
• Status: Completed
• Phase: Phase 2
• Start date: September 18, 2009
• Est. completion date: November 27, 2013

Study information

• Verified date: October 30, 2019
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: November 27, 2013
• Est. primary completion date: November 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type I Diabetes

Intervention

Behavioral:
• Education

• Problem Solving

• Social Learning

• Behavior Modification

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007 Jan;30 Suppl 1:S48-65. — View Citation

Anderson BJ, Auslander WF, Jung KC, Miller JP, Santiago JV. Assessing family sharing of diabetes responsibilities. J Pediatr Psychol. 1990 Aug;15(4):477-92. — View Citation

Anderson EJ, Richardson M, Castle G, Cercone S, Delahanty L, Lyon R, Mueller D, Snetselaar L. Nutrition interventions for intensive therapy in the Diabetes Control and Complications Trial. The DCCT Research Group. J Am Diet Assoc. 1993 Jul;93(7):768-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycemic control, change in dietary intake		18 months
Secondary	Change in social cognitive mediators of behavior; change in psychosocial status; change in body composition, lipids, oxidative stress, and inflammation