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| ID | Type | Description | Link |
|---|---|---|---|
| 09-CH-N234 |
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Background:
Objectives:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral |
| ||
| Problem Solving |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycemic control, change in dietary intake | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in social cognitive mediators of behavior; change in psychosocial status; change in body composition, lipids, oxidative stress, and inflammation |
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INCLUSION CRITERIA:
Child age 8.0-16.9 years
T1D: classical presentation and/or antibody positivity
Diabetes duration greater than or equal to 12 months
Daily insulin dose greater than or equal to 0.5 units/kilogram
Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 9.5%
Insulin regimen
Blood glucose monitoring frequency: Greater than or equal to 3 checks daily
Stable living situation (guardian and address) for greater than or equal to 6 months
Joslin Clinic attendance
EXCLUSION CRITERIA:
Daily use of premixed insulin
Transition to CSII (insulin pump) therapy in last 3 months
Continuous glucose monitoring use in last 3 months
Participation in a different intervention study in the last 6 months
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:
Significant medical or psychiatric illness in caregiver that would prevent active participation in the study
Intent to enroll in another intervention study during the course of this study
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| Name | Affiliation | Role |
|---|---|---|
| Tonja R. Nansel, Ph.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17192379 | Background | 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. doi: 10.2337/dc07-S048. No abstract available. | |
| 2258796 | Background | 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. doi: 10.1093/jpepsy/15.4.477. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Social Learning | Behavioral |
|
| Behavior Modification | Behavioral |
|
| 8320402 | Background | 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. doi: 10.1016/0002-8223(93)91750-k. |
| 38277162 | Derived | Ortiz La Banca Barber R, Volkening LK, Mehta SN, Dassau E, Laffel LM. Effects of Macronutrient Intake and Number of Meals on Glycemic Outcomes Over 1 Year in Youth with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jun;26(6):420-425. doi: 10.1089/dia.2023.0464. Epub 2024 Feb 13. |
| 30709403 | Derived | Sanjeevi N, Lipsky L, Liu A, Nansel T. Differential reporting of fruit and vegetable intake among youth in a randomized controlled trial of a behavioral nutrition intervention. Int J Behav Nutr Phys Act. 2019 Feb 1;16(1):15. doi: 10.1186/s12966-019-0774-9. |
| 30389377 | Derived | Lipsky LM, Haynie DL, Liu A, Nansel TR. Resemblance of Diet Quality in Families of Youth with Type 1 Diabetes Participating in a Randomized Controlled Behavioral Nutrition Intervention Trial in Boston, MA (2010-2013): A Secondary Data Analysis. J Acad Nutr Diet. 2019 Jan;119(1):98-105. doi: 10.1016/j.jand.2018.07.025. Epub 2018 Oct 31. |
| 29770461 | Derived | Quick V, Lipsky LM, Nansel TR. Psychometric properties and factor structure of the adapted Self-Regulation Questionnaire assessing autonomous and controlled motivation for healthful eating among youth with type 1 diabetes and their parents. Child Care Health Dev. 2018 Jul;44(4):651-658. doi: 10.1111/cch.12574. Epub 2018 May 16. |
| 29389510 | Derived | Nansel TR, Lipsky LM, Haynie DL, Eisenberg MH, Dempster K, Liu A. Picky Eaters Improved Diet Quality in a Randomized Behavioral Intervention Trial in Youth with Type 1 Diabetes. J Acad Nutr Diet. 2018 Feb;118(2):308-316. doi: 10.1016/j.jand.2017.10.012. |
| 29371234 | Derived | Eisenberg Colman MH, Quick VM, Lipsky LM, Dempster KW, Liu A, Laffel LMB, Mehta SN, Nansel TR. Disordered Eating Behaviors Are Not Increased by an Intervention to Improve Diet Quality but Are Associated With Poorer Glycemic Control Among Youth With Type 1 Diabetes. Diabetes Care. 2018 Apr;41(4):869-875. doi: 10.2337/dc17-0090. Epub 2018 Jan 25. |
| 27597745 | Derived | Nansel TR, Lipsky LM, Eisenberg MH, Liu A, Mehta SN, Laffel LM. Can Families Eat Better Without Spending More? Improving Diet Quality Does Not Increase Diet Cost in a Randomized Clinical Trial among Youth with Type 1 Diabetes and Their Parents. J Acad Nutr Diet. 2016 Nov;116(11):1751-1759.e1. doi: 10.1016/j.jand.2016.07.005. Epub 2016 Aug 31. |
| 27194309 | Derived | Nansel TR, Lipsky LM, Liu A. Greater diet quality is associated with more optimal glycemic control in a longitudinal study of youth with type 1 diabetes. Am J Clin Nutr. 2016 Jul;104(1):81-7. doi: 10.3945/ajcn.115.126136. Epub 2016 May 18. |
| 27161025 | Derived | Widaman AM, Witbracht MG, Forester SM, Laugero KD, Keim NL. Chronic Stress Is Associated with Indicators of Diet Quality in Habitual Breakfast Skippers. J Acad Nutr Diet. 2016 Nov;116(11):1776-1784. doi: 10.1016/j.jand.2016.03.016. Epub 2016 May 6. |
| 25952160 | Derived | Nansel TR, Laffel LM, Haynie DL, Mehta SN, Lipsky LM, Volkening LK, Butler DA, Higgins LA, Liu A. Improving dietary quality in youth with type 1 diabetes: randomized clinical trial of a family-based behavioral intervention. Int J Behav Nutr Phys Act. 2015 May 8;12:58. doi: 10.1186/s12966-015-0214-4. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |