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

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Completed
CT.gov ID
NCT05411952
Collaborator
(none)
75
1
3
13.1
5.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medical nutrition therapy and carbohydrate counting education
  • Other: Medical nutrition therapy and carbohydrate counting education
  • Other: No intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 13, 2020
Actual Primary Completion Date :
Jan 28, 2021
Actual Study Completion Date :
Sep 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: education-mother and child dyad

Mother and child dyad have received dietary intervention for 6 months

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

Experimental: education-only child

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

Experimental: control

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

Other: No intervention
Control group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls.

Outcome Measures

Primary Outcome Measures

  1. Change in mean of HbA1c from baseline to 6 months [6 months]

    All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05

Secondary Outcome Measures

  1. Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months [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 [6 months]

    All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p< 0.05

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital Gaziantep Turkey 27010

Sponsors and Collaborators

  • Hasan Kalyoncu University

Investigators

  • Study Director: Gulden KOKSAL, Prof., Hasan Kalyoncu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hulya Yilmaz, Research Assistant, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT05411952
Other Study ID Numbers:
  • Hasan-Kalyoncu-UnivHulyaYilmaz
First Posted:
Jun 9, 2022
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hulya Yilmaz, Research Assistant, Hasan Kalyoncu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022