The Effect of Family-Based Behavioral Medical Nutrition Therapy Education on Nutritional Status and Metabolic Control in Children and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in mean of HbA1c from baseline to 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in mean of HbA1c from baseline to 6 months
时间窗: 6 months
All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p\< 0.05
次要结局
- Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months(6 months)
- Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months(6 months)
研究者
Hulya Yilmaz
Research Assistant
Hasan Kalyoncu University