Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial (MYDICLIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- LDL Cholesterol
研究概览
简要总结
This study investigates the effect of detailed, written dietary advice for improving blood lipids, in a primary care setting. n=222 participants will be randomized to Active Intervention or Control Group. After 3 weeks' intervention, participants will receive written feedback on the effect on their blood lipids. After 6 months, another blood sample is drawn and participants will receive further written feedback.
详细描述
The Active Intervention Group will receive detailed dietary advice based on current evidence for food choices that improve LDL cholesterol levels. The information will contain motivational strategies, e.g. "It's great that you want to improve your blood lipids! What are your three main reasons that you want to improve your blood lipids? What food choices suit you? How low can you go?" Participants will receive a table of ten suggested healthy food choices and be instructed to mark for each day a certain food change has been made.
The Control Group will receive similar advice and motivational strategies, with the one difference being the dietary advice, that will focus on Triglycerides instead of LDL cholesterol.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization by sealed envelopes, opened in private. Allocation sequence and envelopes provided by external agent. Participants are instructed not to discuss intervention outside household. No more than one (randomly selected) participant per household allowed.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Listed patient at Svärdsjö Primary Health Care Centre
- •Willing to reduce blood lipids
排除标准
- •Drugs affecting blood lipids (statins, ezetimibe, fibrates, PCSK9-inhibitors, neuroleptic drugs, cortisone, amiodarone, estrogen, progesterone, testosterone, cyclosporin, tacrolimus, loop diuretics, protease inhibitors and anti-convulsants; whereas beta blockers, thiazide diuretics, and SGLT2-inhibitors are allowed under established medication
- •Current malignant disease
- •Extreme diet
- •Abnormal metabolism e.g. uncontrolled hypothyroidism
- •Unability to comprehend written information in Swedish
- •Other participant from same household
- •Current employment on Svärdsjö Primary Health Care Centre
研究组 & 干预措施
LDL Cholesterol
Will receive dietary advice effective for reducing LDL cholesterol.
干预措施: Written advice LDL Cholesterol (Other)
Triglycerides
Will not be aware that they are in fact Control Group. Will receive dietary advice effective for reducing Triglycerides, but neutral for LDL cholesterol.
干预措施: Written advice Triglycerides (Other)
结局指标
主要结局
LDL Cholesterol
时间窗: 3 weeks and 6 months
Change in plasma LDL Cholesterol levels
次要结局
- Cost of intervention(3 weeks and 6 months)
- Stated reasons(3 weeks and 6 months)
- Total Cholesterol(3 weeks and 6 months)
- Responder effect(6 months and 3 weeks, respectively)
- Lipoprotein(a)(3 weeks and 6 months)
- HDL Cholesterol(3 weeks and 6 months)
- Double sampling requirement(3 weeks and 6 months)
- Effective food choices(3 weeks and 6 months)
- Apolipoproteins(3 weeks and 6 months)
- Success rate(3 weeks and 6 months)
- PSCK9(3 weeks and 6 months)
研究者
David Iggman
General practitioner, Principal Investigator, Associated researcher
Uppsala University