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

NCT04089384 | Unknown DMC

• 1 other identifier: UPernambuco11-09
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Weight Loss

Keywords

Obesity; Auriculotherapy; Weight Loss; Nutrition Therapy

Outcome Measures

Primary Outcomes (5)

• Weight loss

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

  12 weeks

• Abdominal circumferece

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

  12 weeks

• Cardiovascular risk

  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.

  12 weeks

• Height

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

  12 weeks

• Body Max Index

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

  12 weeks

Study Arms (3)

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

Other: Control Group

Auriculotherapy Group

ACTIVE COMPARATOR

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

Other: Auriculotherapy Group

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo group

Interventions

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

Control Group

Auriculotherapy Group OTHER

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

Auriculotherapy Group

Placebo group OTHER

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

Placebo group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pernambuco: lead

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Alessandra Galdino

  University of Pernambuco

  STUDY CHAIR

• Andrea Sotero, phD

  University of Pernambuco

  STUDY DIRECTOR

Central Study Contacts

Cicero Jonas R. Benjamim

CONTACT

5588997290435; jonasbenjam1m@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients selected for the research will be interviewed by the same Nutritionist, responsible for the anthropometric assessment, who will use a specific questionnaire to record the personal, socioeconomic and lifestyle information of the patients. A. Control Group: Patients in this group will receive an individualized eating plan every 15 days and a marked micropore. B. Auriculotherapy group: will receive individualized eating plan every 15 days and will undergo 12 auriculotherapy sessions, 1 per week, lasting 5 to 10 minutes for each session, will be compressed by mustard seed in the following points; mouth, stomach, anxiety, hunger and Shen Men. C. Placebo group: will receive individualized eating plan every 15 days and will undergo 12 auriculotherapy sessions, similar to the auriculotherapy group, but the applications will be in sham points, points not indicative for the proposed treatment, wrist and outer ear points.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: January 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 30, 2020
• Last Updated: September 13, 2019

Record last verified: 2019-09