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

Not Applicable

• Conditions: Obesity; Weight Loss
• Interventions: Other: Control Group; Other: Placebo group; Other: Auriculotherapy Group

• Registration Number: NCT04089384
• Lead Sponsor: University of Pernambuco

Brief Summary

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.

Detailed Description

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.

Randomization will be performed near the beginning of the intervention by a researcher not involved in the study using the Epitable application's random number table from the EPI-INFO software. The codes that will define which group the recruited obese patients (Control group, auriculotherapy or placebo) will belong to will be placed in opaque envelopes and sealed by one of the researchers who will not be involved in opening them, and upon recruitment, will be opened by the research assistant, who will register the patients, following the sequence of the drawn envelopes.

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Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Study First Posted: 2019-09-13
• Last Update Posted: 2019-09-13
• Study Start: 2020-01-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Obesity
• Body Mass Index: > 29,9kg/m²

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	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
Placebo group	Placebo group	Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment
Auriculotherapy Group	Auriculotherapy Group	Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity

Primary Outcome Measures

Name	Time	Method
Weight loss	12 weeks	Weight loss will be verified by means of kilogram (kg)
Abdominal circumferece	12 weeks	Will be measured by the abdominal circumference measured in centimeters (cm)
Cardiovascular risk	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	12 weeks	The height measured shall be taken to the extent of centimeters (cm)
Body Max Index	12 weeks	Body Mass Index (BMI) will be evaluated from weight (kg) and height (m) using the formula (kg/ m²).