ObesityNCT04089384
Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
A study testing Auriculotherapy Group in people with Obesity and Weight Loss, run by University of Pernambuco.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 44 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Auriculotherapy Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obesity
- Body Mass Index: > 29,9kg/m²
Who cannot join
- Pregnant women
- Patients with treatment secondary
- Need previous treatment for hormonal control
- Have not properly completed or signed the informed consent form
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
:
- Conditions
- Obesity, Weight Loss
- Being tested
- Control Group, Auriculotherapy Group, Placebo group
- Keywords
- Obesity, Auriculotherapy, Weight Loss, Nutrition Therapy
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
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 GroupOther
Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity
Placebo groupOther
Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Control Group |
| Auriculotherapy Group | Active comparator | Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity Receives: Other: Auriculotherapy Group |
| Placebo group | Placebo comparator | Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss will be verified by means of kilogram (kg)
Measured: 12 weeks
Abdominal circumferece
Will be measured by the abdominal circumference measured in centimeters (cm)
Measured: 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.
Measured: 12 weeks
Height
The height measured shall be taken to the extent of centimeters (cm)
Measured: 12 weeks
Body Max Index
Body Mass Index (BMI) will be evaluated from weight (kg) and height (m) using the formula (kg/ m²).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cicero Jonas Rodrigues Benjamim, University of Pernambuco
- Investigators
- Alessandra Galdino, Study chair, University of PernambucoAndrea Sotero, phD, Study director, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089384
- Sponsor's protocol ID
- UPernambuco11-09
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrative and Complementary Practice in Health as a Strategy in Obesity Treatment
- ClinicalTrials.gov ID
- NCT04089384
- Acronym / sponsor ID
- UPernambuco11-09
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Auriculotherapy, Weight Loss, Nutrition Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Control GroupWill 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 | Active comparator | Other: Auriculotherapy GroupWill receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity |
| Placebo group | Placebo comparator | Other: Placebo groupWill receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Obesity
- Body Mass Index: > 29,9kg/m²
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with treatment secondary
- Need previous treatment for hormonal control
- Have not properly completed or signed the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupWill 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 GroupWill receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity | Other | Auriculotherapy Group |
| Placebo groupWill receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment). | Other | Placebo group |
Primary outcome
Weight loss
Time frame: 12 weeks
Weight loss will be verified by means of kilogram (kg)
Abdominal circumferece
Time frame: 12 weeks
Will be measured by the abdominal circumference measured in centimeters (cm)
Cardiovascular risk
Time frame: 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
Time frame: 12 weeks
The height measured shall be taken to the extent of centimeters (cm)
Body Max Index
Time frame: 12 weeks
Body Mass Index (BMI) will be evaluated from weight (kg) and height (m) using the formula (kg/ m²).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Galdino study chair
University of Pernambuco
Andrea Sotero, phD study director
University of Pernambuco
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy Group in people with Obesity and Weight Loss, run by University of Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cicero Jonas R. Benjamim (5588997290435, jonasbenjam1m@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.