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

• Sponsor: University of Pernambuco (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04089384
• Collaborator: (none)
• Enrollment: 120
• Arms: 3
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Weight Loss	Other: Control Group; Other: Auriculotherapy Group; Other: Placebo group	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: 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
Active Comparator: Auriculotherapy Group Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity	Other: Auriculotherapy Group; Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity
Placebo Comparator: Placebo group Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment	Other: Placebo group; Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment).

Outcome Measures

Primary Outcome Measures

1. Weight loss [12 weeks]

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

2. Abdominal circumferece [12 weeks]

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

3. 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.

4. Height [12 weeks]

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

5. Body Max Index [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 44 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pernambuco

Investigators

• Study Chair: Alessandra Galdino, University of Pernambuco
• Study Director: Andrea Sotero, phD, University of Pernambuco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cicero Jonas Rodrigues Benjamim, Principal Investigator, University of Pernambuco
• ClinicalTrials.gov Identifier: NCT04089384
• Other Study ID Numbers: UPernambuco11-09
• First Posted: Sep 13, 2019
• Last Update Posted: Sep 13, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Cicero Jonas Rodrigues Benjamim, Principal Investigator, University of Pernambuco: Obesity; Auriculotherapy; Weight Loss; Nutrition Therapy
• Additional relevant MeSH terms: Obesity; Weight Loss

Study Results

No Results Posted as of Sep 13, 2019