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临床试验/NCT04089384
NCT04089384Unknown不适用

Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment

University of Pernambuco0 个研究点目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Weight loss

研究概览

简要总结

Obesity is highlighted, pointed as a disease that has been increasingly affecting individuals and becoming an epidemic in recent decades, but auriculotherapy has been shown to contribute to the treatment of this disease.The objective of this study was to evaluate the therapeutic efficacy of auriculotherapy associated with dietary education in reducing weight in obese patients. This is a simple-blind Randomized Clinical Trial.

详细描述

Considering the low cost, benefits and applicability of auriculotherapy in the integral care of the individual, as well as the remaining gap regarding studies involving the practice of auriculotherapy in obese patients with a representative sample, this study will be conducted with The objective of this study was to evaluate the therapeutic efficacy of auriculotherapy associated with dietary education in reducing weight in obese patients.

The study will be performed at the nutrition laboratory III of the University of Pernambuco (UPE) Petrolina campus, with users previously diagnosed with obesity. This is a simple-blind Randomized Clinical Trial, with 3 groups: control group (will receive individualized dietary plan - alimentary reeducation and micropore containing a point made with a black gel pen that will be placed in the ear); auriculotherapy group (will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity) and placebo group (will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment).

Will be included in the study all adult patients of both sexes in the age of 20 years complete for 44 incomplete years, who meet the eligibility criteria.

  • Inclusion criteria: All adult patients seeking treatment for weight loss in August 2019 at the UPE and who agree to participate in the study by signing the Informed Consent Form (ICF). - Exclusion criteria: Pregnant women, patients who are treated with obesity secondary to some pathology and need previous treatment for hormonal control, or have not properly completed or signed the informed consent form.

The sample size was estimated by the EPI INFO software, version 3.5.1. For the calculation it was considered that 20% of adults are obese and 30% have adequate nutritional status, assuming a relative risk of 1.5 to be obese, for a significance level of 95% (1-alpha) and a power value. 80% (1-alpha) with the ratio of unexposed / exposed being 1: 1. . The estimated value of the sample was 36 adults in each group, and the total sample 108, adding 10% in each group to compensate for any losses, resulted in a final sample of 120 individuals, with no 40 participants per group.

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 (Participant)

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index: > 29,9kg/m²

排除标准

  • Pregnant women
  • Patients with treatment secondary
  • Need previous treatment for hormonal control
  • Have not properly completed or signed the informed consent form

研究组 & 干预措施

Control Group

Other

Will receive individualized dietary plan - alimentary reeducation and micropore containing a point made with a black gel pen that will be placed in the ear

干预措施: Control Group (Other)

Auriculotherapy Group

Active Comparator

Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity

干预措施: Auriculotherapy Group (Other)

Placebo group

Placebo Comparator

Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment

干预措施: Placebo group (Other)

结局指标

主要结局

Weight loss

时间窗: 12 weeks

Weight loss will be verified by means of kilogram (kg)

Abdominal circumferece

时间窗: 12 weeks

Will be measured by the abdominal circumference measured in centimeters (cm)

Cardiovascular risk

时间窗: 12 weeks

The waist circumference in centimeters (cm) will be used to assess the decrease in cardiovascular risk, considering the cutoff points of the world health organization. Men -Increased ≥ 94 cm; Substantially increased ≥ 102cm. Woman - Increased ≥ 80 cm; Substantially increased ≥ 88cm.

Height

时间窗: 12 weeks

The height measured shall be taken to the extent of centimeters (cm)

Body Max Index

时间窗: 12 weeks

Body Mass Index (BMI) will be evaluated from weight (kg) and height (m) using the formula (kg/ m²).

次要结局

未报告次要终点

研究者

发起方
University of Pernambuco
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cicero Jonas Rodrigues Benjamim

Principal Investigator

University of Pernambuco

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