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

Type1diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411952
• Other study ID #: Hasan-Kalyoncu-UnivHulyaYilmaz
• Status: Completed
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: June 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 15, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Other:
• Medical nutrition therapy and carbohydrate counting education
Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
• Medical nutrition therapy and carbohydrate counting education
Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian
• No intervention
Control group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls.

Locations

Country	Name	City	State
Turkey	Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	6 months
Secondary	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	6 months