The Efficacy of a Transcultural Diabetes Nutrition Algorithm (tDNA) Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes in an Outpatient Clinic Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
The aim of this study was to investigate the effectiveness of structured lifestyle intervention following a transcultural diabetes nutrition algorithm (tDNA) care compared to usual diabetes care in patients with overweight, obesity and type 2 diabetes (T2D), receiving either the motivational interviewing counseling or conventional counselling technique in an outpatient clinic setting.
The hypothesis is weight loss and glycated haemoglobin (A1C) level will be improved in patients following the tDNA care compared to usual diabetes care and the improvements will be greater in those receiving motivational interviewing counseling than conventional counselling.
详细描述
The main objective of this study was to investigate the effectiveness of structured lifestyle intervention following a transcultural diabetes nutrition algorithm (tDNA) care compared to usual diabetes care in patients with overweight, obesity and type 2 diabetes (T2D), receiving either the motivational interviewing counseling or conventional counseling technique in an outpatient clinic setting.
The specific objectives are:
- To compare changes in the primary outcomes (weight, body mass index and A1C) in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, 6 months and 12 months of intervention.
- To compare changes in the secondary outcomes (waist circumference, percentage body fat, fasting plasma glucose, lipid profile, high sensitivity-C-Reactive Protein and blood pressure) in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, and 6 months of intervention.
- To compare the changes in dietary intake, Weight Efficacy Lifestyle, exercise and physical activity in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, 6 months and 12 months of intervention.
Study Design: This is a prospective open-label randomized clinical trial conducted in patients with overweight, obesity and T2D in an outpatient clinic setting.
Study duration: This study was conducted for a period of 12 months consisting of 6 months of intervention phase followed by subsequent 6 months of follow up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus, requiring weight loss
- •Treated with oral hypoglycaemic medications and/or lifestyle modifications
- •Medications have been optimised with no changes in pharmacotherapy in the past three months
- •Aged between 30 to 65 years
- •BMI of >23 kg/m²
- •A1C between 7% to 9%
- •Failed to achieve HbA1c reduction in the past three months even after seeing a dietitian
- •Willing to comply with study procedures.
排除标准
- •Patients whom weight loss might not be safe
- •Patients diagnosed with type 1 diabetes mellitus and type 2 diabetes mellitus with basal or multiple insulin injections
- •Patients with weight loss exceeding 5 kg in the past three months
- •Patients with current use of medications/meal replacements for weight loss
- •Patients with cancer requiring treatment for the past five years, except of non-melanoma skin cancers or cancers that have been clearly cured
- •Patients with history of bariatric surgery, small bowel resection, or extensive bowel resection
- •Patients with cardiovascular disease (heart attack or procedure within past three months or participation in cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischaemic attacks in the past three months, or documented history of pulmonary embolus for the past six months)
- •Patients receiving chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion.
- •Patients with renal disease with eGFR <60 ml/min (based on MDRD) or currently receiving dialysis
- •Patients with chronic alcoholism
- •Patients who are currently pregnant or nursing
- •Patients who plan to relocate where it does not permit full participation in the study.
研究组 & 干预措施
tDNA-CC group
Follow tDNA intervention and conventional counselling
干预措施: tDNA-CC group (Other)
tDNA-MI group
Follow tDNA intervention and motivational interviewing counselling
干预措施: tDNA-MI group (Other)
UC group
Follow a conventional diet with standard diabetes support and lifestyle education
干预措施: UC group (Other)
结局指标
主要结局
Change in Weight
时间窗: 6 months, 12 months
Anthropometry
Change in Glycated haemoglobin (A1C)
时间窗: 6 months, 12 months
Biochemical measure
次要结局
- Change in percentage body fat(6 months)
- Change in exercise minutes(6 months, 12 months)
- Change in energy intake and macronutrients(6 months, 12 months)
- Change in systolic and diastolic blood pressure(6 months)
- Change in Weight Efficacy Lifestyle (WEL) scores(6 months, 12 months)
- Change in High sensitivity C-Reactive Protein (HsCRP)(6 months)
- Change in fasting blood glucose(6 months)
- Change in total cholesterol, LDL-C and HDL-C(6 months)
研究者
Winnie Chee
Principal Investigator
International Medical University