Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
Primary Purpose
Obesity, Weight Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control Group
Auriculotherapy Group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Auriculotherapy, Weight Loss, Nutrition Therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Placebo Comparator
Arm Label
Control Group
Auriculotherapy Group
Placebo group
Arm 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
Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity
Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment
Outcomes
Primary Outcome Measures
Weight loss
Weight loss will be verified by means of kilogram (kg)
Abdominal circumferece
Will be measured by the abdominal circumference measured in centimeters (cm)
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.
Height
The height measured shall be taken to the extent of centimeters (cm)
Body Max Index
Body Mass Index (BMI) will be evaluated from weight (kg) and height (m) using the formula (kg/ m²).
Secondary Outcome Measures
Full Information
NCT ID
NCT04089384
First Posted
September 11, 2019
Last Updated
September 12, 2019
Sponsor
University of Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT04089384
Brief Title
Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
Official Title
Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Auriculotherapy, Weight Loss, Nutrition Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm 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
Arm Title
Auriculotherapy Group
Arm Type
Active Comparator
Arm Description
Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention 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
Intervention Type
Other
Intervention Name(s)
Auriculotherapy Group
Intervention Description
Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment).
Primary Outcome Measure Information:
Title
Weight loss
Description
Weight loss will be verified by means of kilogram (kg)
Time Frame
12 weeks
Title
Abdominal circumferece
Description
Will be measured by the abdominal circumference measured in centimeters (cm)
Time Frame
12 weeks
Title
Cardiovascular risk
Description
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.
Time Frame
12 weeks
Title
Height
Description
The height measured shall be taken to the extent of centimeters (cm)
Time Frame
12 weeks
Title
Body Max Index
Description
Body Mass Index (BMI) will be evaluated from weight (kg) and height (m) using the formula (kg/ m²).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cicero Jonas R. Benjamim
Phone
5588997290435
Email
jonasbenjam1m@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Galdino
Organizational Affiliation
University of Pernambuco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Sotero, phD
Organizational Affiliation
University of Pernambuco
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
We'll reach out to this number within 24 hrs