Skip to main content
OpenTrials
Completed

NCT Number: NCT05411952

Family-Based Behavioral Medical Nutrition Therapy Education 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type1diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital

Gaziantep, 27010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

No intervention

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2022
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.