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

Hasan Kalyoncu University

Status: Completed

Conditions: Type1diabetes

Treatments: Other: Medical nutrition therapy and carbohydrate counting education; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05411952

Hasan-Kalyoncu-UnivHulyaYilmaz

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

education-mother and child dyad

Experimental group

Description:

Mother and child dyad have received dietary intervention for 6 months

Treatment:

Other: Medical nutrition therapy and carbohydrate counting education

Other: Medical nutrition therapy and carbohydrate counting education

education-only child

Experimental group

Description:

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

Treatment:

Other: Medical nutrition therapy and carbohydrate counting education

Other: Medical nutrition therapy and carbohydrate counting education

control

Experimental group

Description:

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

Treatment:

Other: No intervention