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临床试验/NCT03423966
NCT03423966已完成不适用

Effect of the Use of Smartphone Pedometers on the Weight of Overweight and Obese Clients at the General Outpatient Department, National Hospital Abuja.

National Hospital, Abuja2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2018年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
194
试验地点
2
主要终点
Weight Loss

研究概览

简要总结

The study sets out to determine the effect of smartphone pedometers on the body mass of overweight and obese clients at the general outpatient department, national hospital Abuja.

It is a synopsis of the proposed dissertation submitted to the West African College of Physicians in partial fulfillment of the requirements for the part 11 Fellowship examination of the faculty of Family Medicine.

详细描述

3.1 Study Area The Hospital is a melting pot of referral cases, fresh cases, executive patients and the masses alike and therefore gives a scout picture of the non-communicable diseases situation in Nigeria. First contact to undifferentiated patients is offered in the clinic. It is accredited by both the West African College of Physician and the National Postgraduate Medical College of Nigeria for residency training in Family Medicine.

3.2 Study Population The study will be carried out among consenting adult overweight and obese patients attending the GOPC of National Hospital Abuja.

3.3 Study Design This study is a Randomized Controlled Trial with parallel open label design.

3.4 Duration of Study The study will be conducted over a period of 24 weeks with a lead in period of 4 weeks for recruitment.

3.5 Minimum Sample Size Estimation The minimum sample size was calculated using the formula for sample size estimation for tests between two independent means.

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

入选标准

  • Consenting screened participants that are overweight or obese who want to lose at least 5% of their baseline weight.
  • Adults aged 18 to 65 years old.

排除标准

  • Clients on weight lose drugs because this may confound the cause of the weight loss.
  • Patients with conditions that do not allow mobility.
  • Patients with major organ failure because such patients may not be so stable to cope with prescribed exercise schedule.
  • Pregnancy; present, intending and 6 months postpartum because the cause of the weight loss or gain may be attributed to the pregnancy.
  • Morbidly obese clients because this are candidates for drug therapy and surgical interventions and it will be unethical to delay such interventions.
  • Clients with no android smartphone that are randomized to the intervention group because the intervention will not be possible.

结局指标

主要结局

Weight Loss

时间窗: 4 months

Changes in weight after the use of pedometer app

次要结局

  • Body Mass Index(4 month)
  • Waist Circumference(4 Months)
  • Blood Pressure(4 months)

研究者

发起方
National Hospital, Abuja
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ngong Hipoletus Cyprian

Senior Registrar and Secretary, Research and Academic Committee

National Hospital, Abuja

研究点 (2)

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