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

University of Pernambuco

Status: Unknown

Conditions: Weight Loss; Obesity

Treatments: Other: Auriculotherapy Group; Other: Control Group; Other: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT04089384

UPernambuco11-09

Details and patient eligibility

About

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.

Full 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.

:

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Control Group

Other group

Description:

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

Treatment:

Other: Control Group

Auriculotherapy Group

Active Comparator group

Description:

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

Treatment:

Other: Auriculotherapy Group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo group