The Effect of Medical Nutrition Therapy and Follow-Up Frequency on Parameters Related to Metabolic Syndrome in Individuals with Metabolic Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- waist circumference
研究概览
简要总结
There is no study that has investigated the effects of medical nutrition therapy and more frequent follow-up via telehealth on metabolic syndrome parameters in patients with MetS who have multiple metabolic disorders such as being overweight, prediabetic/diabetic, dyslipidemic and having increased blood pressure. This study was conducted to examine the effects of medical nutrition therapy and increased follow-up via telephone calls on MetS-related parameters in individuals with MetS.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with HbA1c values <8.5%
- •Diagnosed with MetS by a physician according to the criteria declared by the consensus of the "International Diabetes Federation Task Force on Epidemiology and Prevention, National Heart, Lung, and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society, and International Association for the Study of Obesity" were included.
排除标准
- •Taking anti diabetic agents other then metformin
- •Taking anti hyperlipidemic agents
- •Taking anti hypertensive agents
- •Using food supplements (w-3, chromium, multivitamins) that could affect metabolic parameters,
- •Having kidney failure,
- •Having liver failure,
- •Having immune failure
- •Having chronic gastrointestinal system disease
- •Having cancer
- •Having type 1 diabetes
- •Being pregnant or breastfeeding.
研究组 & 干预措施
Intervention Group
Participants in this group attended face-to-face consultations at baseline, and at the 1st, 2nd, and 3rd months (a total of four visits). These sessions focused on providing guidance for dietary and lifestyle modifications.
干预措施: Dietary counseling (Other)
Intervention Group
Participants in this group attended face-to-face consultations at baseline, and at the 1st, 2nd, and 3rd months (a total of four visits). These sessions focused on providing guidance for dietary and lifestyle modifications.
干预措施: calling via telephone (Other)
Intensive Intervention
This group followed the same face-to-face consultation schedule as the intervention group (baseline, 1st, 2nd, and 3rd months). In addition, participants were contacted weekly via phone to assess dietary adherence and provide ongoing motivation and support, making this a more frequent and intensive intervention.
Across all groups, the study primarily aimed to evaluate changes in weight loss, blood sugar, lipid levels, and metabolic syndrome parameters, while assessing the impact of intervention intensity on these outcomes.
干预措施: Dietary counseling (Other)
Control Group
Participants in this group were seen in person only twice, at baseline and at the 3rd month. No additional interventions were applied, and the aim was to observe the natural course of their condition.
结局指标
主要结局
waist circumference
时间窗: Baseline, 1 month, 2 months, and 3 months after the start of the intervention
Waist circumference, which is an indicator of abdominal obesity, the central component of metabolic syndrome, was determined as the primary outcome because of its strong association with cardiometabolic risk and its correlation with other MetS components, and because it is a significant measure in reflecting the overall effect of the intervention.
次要结局
- fasting plasma glucose, triglyceride, HDL-C and blood pressure (Number of metabolic syndrome criteria)(Baseline, 1 month, 2 months, and 3 months after the start of the intervention)
研究者
Kubra Yildiz Guler
Research University
Hacettepe University