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临床试验/NCT03442712
NCT03442712已完成不适用

Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
body mass index

研究概览

简要总结

Obesity is a common global health problem. A three-arm randomised waitlist-controlled feasibility trial is proposed. A total of 59 subjects (19-21 subjects per arm) will be recruited. The three groups are AA plus smartphone application (experimental group); AA only (comparison group); and Waitlist control group. In the experimental group, seeds will be applied on six specific ear acupoints of the subjects by the researcher. Subjects will be requested to apply pressure on the acupoints thrice per day. They will install a smartphone App which will send out regular reminders for pressing, allow the subjects to input the number of bowel open, compliance rate, and difficulties entered during the process for timely advice. The total treatment period will be 8 weeks. Outcome measures will be conducted at baseline and postintervention at 8 weeks, including obesity and anthropometric index, leptin concentration and adiponectin level. Patient satisfaction towards the therapy, the use of the smartphone application and the implementation of the treatment protocol will be determined.

详细描述

Obesity is a common global health problem. It increases the risk of many chronic illnesses, such as hypertension, type 2 diabetes mellitus and cardiovascular diseases. Conventional approaches to alleviate obesity are medications, exercise, dietary control, behaviour modification therapy or bariatric surgeries. However, the safety of anti-obesity agents is a concern, and gastric bypass surgery and other bariatric surgeries also pose potential risks after operation. Auricular acupuncture therapy is frequently used to treat obesity. However, the use of needles for auricular acupuncture may be unacceptable to people. Some researchers attempted to adopt a combined approach by integrating auriculotherapy with diet restriction, and the effect solely attributed to auriculotherapy cannot be determined. On the other hand, auricular acupressure (AA) is a safe, noninvasive, inexpensive and easily self-administered approach that causes very few adverse effects. Previous evidence has demonstrated that AA is an effective intervention to reduce body weight, increase satiety and self-efficacy on weight control through the self-administration of seeds pressing several times per day, after the seeds are applied by the researchers on the ear acupoints. It is associated with the decreased leptin levels and an increase of adiponectin level in which these hormones are associated with weight loss. However, therapists may have difficulties to monitor the compliance of subjects to perform seed pressing which in turn affecting the intervention dosages. This study aims to evaluate the feasibility of self-administered AA integrated with mobile device reminders for weight reduction in individuals with overweightness or obesity. A three-arm randomised waitlist-controlled feasibility trial is proposed. A total of 59 subjects (19-21 subjects per arm) will be recruited. The three groups are AA plus smartphone application (experimental group); AA only (comparison group); and Waitlist control group. In the experimental group, seeds will be applied on six specific ear acupoints of the subjects by the researcher. Subjects will be requested to apply pressure on the acupoints thrice per day. They will install a smartphone App which will send out regular reminders for pressing, allow the subjects to input the number of bowel open, compliance rate, and difficulties entered during the process for timely advice. The total treatment period will be 8 weeks. Outcome measures will be conducted at baseline and postintervention at 8 weeks, including obesity and anthropometric index, leptin concentration and adiponectin level. Patient satisfaction towards the therapy, the use of the smartphone application and the implementation of the treatment protocol will be determined.

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
Single (Outcomes Assessor)

盲法说明

The effects of the treatment will be evaluated by another researcher (second RA) who is blinded to the type of treatment modality received by the participants.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Overweightness, with body mass index (BMI) ≥ 25.0 kg/m2 in accordance with the BMI classification of the World Health Organization (WHO)
  • Subjects that have neither received other weight control measures (manoeuvres) nor experienced medical and/or drug history within the last 3 months
  • No ear injury, such as inflammation or lesions, and no medical history of ear surgery within the last 6 months
  • Smartphone user (IOS and android)
  • Exclusion criteria:
  • (1) diabetes, severe hypertension, heart disease or endocrine abnormalities,; (2) pregnancy; (3) eating disorders screened with a 5-item SCOFF questionnaire (Bradford et al. 2010); (4) psychiatric and mental disorders.

排除标准

  • 未提供

研究组 & 干预措施

Treatment arm 1

Active Comparator

Auricular acupressure (AA) plus smartphone App:

Semen Vaccaria laccaria will be applied on one ear only, and seed plasters will be changed every 3 days to 4 days to the opposite ear. Subjects will be requested to apply pressure on the acupoints thrice per day. The subjects will install the smartphone App specifically designed for this study. The App will send out regular AA reminders to the subjects. The total treatment period will be 8 weeks.

干预措施: Auricular acupressure plus smartphone App (Other)

Treatment arm 2

Active Comparator

The participants will only receive AA treatment and are required to perform daily self-administered seeds pressing.

干预措施: Auricular acupressure (Other)

Treatment arm 3

No Intervention

The participants in the waitlist control group will maintain their usual dietary and exercising patterns.

结局指标

主要结局

body mass index

时间窗: up to 8 weeks

body mass index is defined as the body mass divided by the square of the body height, i.e. kg/meter square

次要结局

  • Bowel open(up to 8 weeks)
  • Appetite parameters which include hunger, fullness and satiety level(up to 8 weeks)
  • Adiponectin level(up to 8 weeks)
  • Fat percentage(up to 8 weeks)
  • Leptin concentration(up to 8 weeks)
  • Participants' expectation(baseline)
  • Patient satisfaction(up to 8 weeks)
  • waist hip ratio(up to 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorna Suen

Associate Professor

The Hong Kong Polytechnic University

研究点 (1)

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