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Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Medical nutrition therapy and carbohydrate counting education
Medical nutrition therapy and carbohydrate counting education
No intervention
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1diabetes focused on measuring Type 1 diabetes, nutrition education, metabolic control

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

education-mother and child dyad

education-only child

control

Arm Description

Mother and child dyad have received dietary intervention for 6 months

Children have received dietary intervention for 6 months. But their mothers didn't receive any dietary intervention

Control group did't receive any dietary intervention during the study

Outcomes

Primary Outcome Measures

Change in mean of HbA1c from baseline to 6 months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05

Secondary Outcome Measures

Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05

Full Information

First Posted
May 30, 2022
Last Updated
June 6, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05411952
Brief Title
Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes
Official Title
The Effect of Family-Based Behavioral Medical Nutrition Therapy Education on Nutritional Status and Metabolic Control in Children and Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Type 1 diabetes, nutrition education, metabolic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
education-mother and child dyad
Arm Type
Experimental
Arm Description
Mother and child dyad have received dietary intervention for 6 months
Arm Title
education-only child
Arm Type
Experimental
Arm Description
Children have received dietary intervention for 6 months. But their mothers didn't receive any dietary intervention
Arm Title
control
Arm Type
Experimental
Arm Description
Control group did't receive any dietary intervention during the study
Intervention Type
Other
Intervention Name(s)
Medical nutrition therapy and carbohydrate counting education
Intervention Description
Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
Intervention Type
Other
Intervention Name(s)
Medical nutrition therapy and carbohydrate counting education
Intervention Description
Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Control group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls.
Primary Outcome Measure Information:
Title
Change in mean of HbA1c from baseline to 6 months
Description
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months
Description
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Time Frame
6 months
Title
Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months
Description
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulden KOKSAL, Prof.
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital
City
Gaziantep
ZIP/Postal Code
27010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes

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