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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04834180
Other study ID # uportoweightloss
Secondary ID uportoweightloss
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2015
Est. completion date December 15, 2015

Study information

Verified date April 2021
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The implications of obesity, especially visceral fat, in health are well known. It would be desirable to control obesity by safe and effective treatment modalities. Aim: To assess the effectiveness of Auricular Acupuncture (AA) on body weight loss in a Portuguese sample.


Description:

Methods: After a pre-study, a prospective experimental randomized, controlled and single-blinded study was conducted. The sample included 31 adult women with ages ranging from 20 to 51 years old. The groups had a frequency of physical activity ≥ 2 and ≤ 4 times per week. Individuals with BMI ≤ 24.9 Kg/m2 and pregnant women excluded from the study. All participants were then randomized into one of three groups: group 1 was treated with Vaccaria seeds plus diet therapy, group 2 with ASP needles plus diet therapy and finally, group 3 received only diet therapy. A licensed nutritionist prescribed the hypocaloric diet plan. Baseline evaluation included anthropometric measures collected according to standardized procedures. They received two treatments per week for a total of 6 weeks. After one month of follow-up, all the anthropometric measures were reevaluated. Main Parameters: Weight/body composition by bioelectrical impedance analysis. Secondary parameters: Waist to height ratio (WHtR), weight and Body Mass Index (BMI).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 15, 2015
Est. primary completion date September 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults - Unfamiliar to acupuncture Exclusion Criteria: - Psychotropic medication - Psychiatric or thyroid disorders - Pregnancy

Study Design


Intervention

Dietary Supplement:
Hypocaloric diet plan
The hypocaloric diet is one in which there is a reduction of daily calories or foods with high caloric density usually in order to aid weight loss.
Other:
Auricular Acupuncture
Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.
Acupressure
Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Andreia Vieira

Outcome

Type Measure Description Time frame Safety issue
Primary Weight (kg) TANITA® bio-impedance scale (model 762) 1 month
Primary Waist Perimeter (cm) tape measure from SECA® (model 203) 1 month
Primary height (cm) SECA® stadiometer (model 208) 1 month
Primary body fat (%) TANITA® bio-impedance scale (model 762) 1 month
Primary Body mass index (kg/m2) Body mass index is defined as the body mass divided by the square of the body height. 1 month
Primary Waist-to-height ratio (cm2) The WHTR was obtained by dividing the waist circumference (cm) by height (cm). 1 month
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