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

NCT ID: NCT05411952

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2021-09-15

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.

Conditions

Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

education-mother and child dyad

Mother and child dyad have received dietary intervention for 6 months

Group Type: EXPERIMENTAL

Medical nutrition therapy and carbohydrate counting education

Intervention Type: OTHER

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

education-only child

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

Group Type: EXPERIMENTAL

Medical nutrition therapy and carbohydrate counting education

Intervention Type: OTHER

Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian

control

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

Group Type: EXPERIMENTAL

No intervention

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

No intervention

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasan Kalyoncu University

OTHER

Sponsor Role: lead

Responsible Party

Hulya Yilmaz

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulden KOKSAL, Prof.

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital

Gaziantep, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Hasan-Kalyoncu-UnivHulyaYilmaz

Identifier Type: -

Identifier Source: org_study_id