- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411952
Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes
June 6, 2022 updated by: Hulya Yilmaz, Hasan Kalyoncu University
The Effect of Family-Based Behavioral Medical Nutrition Therapy Education on Nutritional Status and Metabolic Control in Children and Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus (T1DM) is a heterogeneous condition and is an absolute insulin deficiency resulting from autoimmune-mediated destruction of pancreatic β-cells (1).
The incidence of T1DM has been increasing globally since the 1950s, particularly in children, with an average annual increase of 3-4% over the past three decades.Despite the advances in medical treatment and technology, nutritional therapy continues to be the main component of diabetes treatment.
Medical nutrition further improves metabolic control outcomes when T1DM care is combined with other treatments.This study was conducted to examine the effect of family-based behavioral medical nutrition therapy training on nutritional status and metabolic control in children and adolescents with Type 1 diabetes.
Study Overview
Status
Completed
Conditions
Detailed Description
The research was carried out with children and adolescents aged 8-18 years who were followed up with the diagnosis of Type 1 Diabetes Mellitus in Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital.
The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method.
Medical nutrition therapy and carbohydrate counting training were given to mothers and children in the Intervention 1 group, and only to children and adolescents in the Intervention 2 group.
The control group did not receive medical nutrition therapy and carbohydrate counting training.
At the beginning (0. month) and at the end (6.
month) of the study, 3 consecutive day/24-hour food consumption records and anthropometric measurements of the individuals were assessed, BMI z-scores and height z-scores were calculated, Mediterranean Diet Quality Index Scale (KIDMED), Diabetes Eating Problems Survey-Revised (DEPS-R), Physical Activity Questionnaire for Children and Adolescents (PAQ-C and PAQ-A) were administered and Healthy Eating Index 2015 (HEI-2015) scores were calculated.
Routinely assessed blood findings of the individuals were checked at the beginning (0. month), 3rd month and 6th month of the study.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
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
-
-
-
Gaziantep, Turkey, 27010
- Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital
-
-
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 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 8-18 years old,
- Being diagnosed with T1DM for at least ≥1 year, maximum ≤5 years,
- Latest HbA1c ≥6.5% - <13.5%,
- Receiving intensive insulin therapy (at least 3 times a day bolus and 1 time basal insulin administration or using an insulin pump),
- No communication problems
- Children and adolescents without any other disease accompanying diabetes were included in the study.
Exclusion Criteria:
- Celiac, cystic fibrosis etc. with gastrointestinal diseases,
- Using any drug that may affect glucose metabolism,
- Switched from an insulin pen to an insulin pump in less than 6 months,
- Involved in any other intervention work in the last 6 months,
- and individuals with communication problems were not included in the 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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: education-mother and child dyad
Mother and child dyad have received dietary intervention for 6 months
|
Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
|
Experimental: education-only child
Children have received dietary intervention for 6 months.
But their mothers didn't receive any dietary intervention
|
Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
|
Experimental: control
Control group did't receive any dietary intervention during the study
|
Control group didn't receive any intervention by trained dietitian.
Furthermore they continued their routine health controls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean of HbA1c from baseline to 6 months
Time Frame: 6 months
|
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months
Time Frame: 6 months
|
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
|
6 months
|
Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months
Time Frame: 6 months
|
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gulden KOKSAL, Prof., Hasan Kalyoncu University
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 (Actual)
August 13, 2020
Primary Completion (Actual)
January 28, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
May 30, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 9, 2022
Study Record Updates
Last Update Posted (Actual)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hasan-Kalyoncu-UnivHulyaYilmaz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Type1diabetes
-
Silesian Centre for Heart DiseasesThe Jerzy Kukuczka Academy of Physical Education in KatowiceCompletedtype1diabetesPoland
-
Vastra Gotaland RegionCompletedType1diabetesSweden
-
Rabin Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust; DreaMed DiabetesRecruiting
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)Completed
-
University of Southern CaliforniaThe Leona M. and Harry B. Helmsley Charitable TrustCompletedType1diabetesUnited States
-
Aalborg University HospitalAalborg University; Steno Diabetes Center NordjyllandCompletedType1diabetes | Hemodialysis | Type2DiabetesDenmark
-
Radboud University Medical CenterUnknownType1diabetes | Hypoglycemia UnawarenessNetherlands
-
Vastra Gotaland RegionRecruitingType1diabetes | Psychology Functional BehaviorSweden
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Active, not recruitingHypoglycemia | Type1diabetes | Islet Cell Transplantation | Hypoglycemia UnawarenessUnited States
-
University of British ColumbiaJuvenile Diabetes Research Foundation; Brain CanadaNot yet recruiting
Clinical Trials on Medical nutrition therapy and carbohydrate counting education
-
Universidade Nova de LisboaRecruitingType 1 DiabetesPortugal
-
University of Alabama, TuscaloosaAcademy of Nutrition and DieteticsRecruitingBrain InjuriesUnited States
-
Steno Diabetes Center CopenhagenUniversity of CopenhagenCompletedGlucose Metabolism Disorders | Type1diabetes | Type1 Diabetes MellitusDenmark
-
Göteborg UniversityCompletedDiabetes Mellitus, Type 1
-
The Hospital for Sick ChildrenThe Lawson FoundationCompletedAn Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 DiabetesType 1 Diabetes MellitusCanada
-
Fondation LenvalCompleted
-
Steno Diabetes Center CopenhagenUniversity of CopenhagenCompletedGlucose Metabolism Disorders | Diabetes Mellitus, Type 2 | Type2 DiabetesDenmark
-
University of KentuckyAmerican Diabetes AssociationRecruitingDiabetes Mellitus, Type 2United States
-
Hugo Mendieta ZeronFogarty International Center of the National Institute of Health; Instituto...CompletedGestational Weight GainMexico
-
IRCCS San RaffaeleCompletedDiabetes Mellitus, Type 1 | Insulin Pump, ProgrammableItaly