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

NCT05411952 | Completed

• 1 other identifier: Hasan-Kalyoncu-UnivHulyaYilmaz
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Keywords

Type 1 diabetes, nutrition education, metabolic control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months

  6 months

• Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months

  6 months

Study Arms (3)

education-mother and child dyad

EXPERIMENTAL

Mother and child dyad have received dietary intervention for 6 months

Other: Medical nutrition therapy and carbohydrate counting education

education-only child

EXPERIMENTAL

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

Other: Medical nutrition therapy and carbohydrate counting education

control

EXPERIMENTAL

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

Other: No intervention

Interventions

Medical nutrition therapy and carbohydrate counting education OTHER

Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian

education-mother and child dyad

No intervention OTHER

Control group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls.

control

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gulden KOKSAL, Prof.

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 9, 2022
• Study Start: August 13, 2020
• Primary Completion: January 28, 2021
• Study Completion: September 15, 2021
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)