Type I DiabetesPhase 2NCT00999375
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
A Phase 2 study testing Education, Problem Solving and Social Learning in people with Type I Diabetes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Education, Problem Solving and Social Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2009to 27 Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- a. Greater than or equal to 3 injections daily, OR
- b. Continuous subcutaneous insulin infusion (insulin pump) (CSII)
- 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
- a. At least one Joslin Clinic visit in last year, AND
- b. Anticipated care at Joslin Clinic for duration of study
Who cannot join
- 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
Show all 13Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Type I Diabetes
- Being tested
- Education, Problem Solving, Social Learning, Behavior Modification
- Keywords
- Type 1 Diabetes, Diet, Behavioral Intervention, Children, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Problem SolvingBehavioural
Social LearningBehavioural
Behavior ModificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Behavioral: Education; Behavioral: Problem Solving; Behavioral: Social Learning; Behavioral: Behavior Modification |
| Group B | Active comparator | Not described Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control, change in dietary intake
Measured: 18 months
Secondary outcomes (1)
Change in social cognitive mediators of behavior; change in psychosocial status; change in body composition, lipids, oxidative stress, and inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study start18 Sep 2009
- Primary completion27 Nov 2013
- Study completion27 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tonja R. Nansel, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999375
- Sponsor's protocol ID
- 999909234
- Other IDs
- 09-CH-N234
- Status last verified
- 30 Oct 2019
- First submitted
- 20 Oct 2009
- Last updated
- 29 Nov 2019
- Results posted
- No
Publications
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.
PubMed 17192379Anderson 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.
PubMed 2258796Anderson 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.
PubMed 8320402Ortiz 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.
PubMed 38277162Sanjeevi 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.
PubMed 30709403Lipsky 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.
PubMed 30389377Quick 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.
PubMed 29770461Nansel 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.
PubMed 29389510Eisenberg 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.
PubMed 29371234Nansel 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.
PubMed 27597745Nansel 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.
PubMed 27194309Widaman 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.
PubMed 27161025Nansel 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.
PubMed 25952160
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
- ClinicalTrials.gov ID
- NCT00999375
- Acronym / sponsor ID
- 999909234
- Conditions
- Type I Diabetes
- Keywords
- Type 1 Diabetes, Diet, Behavioral Intervention, Children, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 18 Sep 2009
- Primary completion
- 27 Nov 2013 (actual)
- Study completion
- 27 Nov 2013 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Education, Behavioral: Problem Solving, Behavioral: Social Learning, Behavioral: Behavior Modification |
| Group B | Active comparator | Behavioral: Education |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
Key exclusion criteria (13 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education | Behavioural | Group A, Group B |
| Problem Solving | Behavioural | Group A |
| Social Learning | Behavioural | Group A |
| Behavior Modification | Behavioural | Group A |
Primary outcome
Change in glycemic control, change in dietary intake
Time frame: 18 months
1 secondary outcome
Change in social cognitive mediators of behavior; change in psychosocial status; change in body composition, lipids, oxidative stress, and inflammation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 17192379American 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.
- Background: PubMed 2258796Anderson 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.
- Background: PubMed 8320402Anderson 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.
- Derived from this study: PubMed 38277162Ortiz 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.
- Derived from this study: PubMed 30709403Sanjeevi 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.
- Derived from this study: PubMed 30389377Lipsky 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.
- Derived from this study: PubMed 29770461Quick 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.
- Derived from this study: PubMed 29389510Nansel 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.
- Derived from this study: PubMed 29371234Eisenberg 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.
- Derived from this study: PubMed 27597745Nansel 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.
- Derived from this study: PubMed 27194309Nansel 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.
- Derived from this study: PubMed 27161025Widaman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonja R. Nansel, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Education, Problem Solving and Social Learning in people with Type I Diabetes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control, change in dietary intake (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999375, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.