Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture

NCT ID: NCT04834180

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2015-12-15

Brief 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.

Detailed 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).

Conditions

Weight Loss; Abdominal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vaccaria seeds plus diet therapy

Vaccaria seeds at the exterior side of the ear area, standard points were selected according to clinical experience in traditional Chinese medicine: Shenmen (TF4), Stomach (CO4), Hunger, Mouth (CO1), Point Zero HX1) and Sanjiao (CO17). Mustard seeds (Vaccaria ear seeds, Beijing Zhongyan Taihe Medicine, Beijing, China) were used, plus diet therapy prescribed by a licensed nutritionist.

Group Type: SHAM_COMPARATOR

Hypocaloric diet plan

Intervention Type: DIETARY_SUPPLEMENT

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.

Acupressure

Intervention Type: OTHER

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.

ASP needles plus diet therapy

ASP needles on the outside of the ear standard points were selected according to clinical experience in traditional Chinese medicine: ASP gold needles, strengthening the centre with point 0 (the umbilicus) in the dominant ear, Porta Fortunae in the non-dominant ear, Barbiturate in the non-dominant ear, Psychosomatique key point in the dominant ear and the point Aggression, plus diet therapy prescribed by a licensed nutritionist.

Group Type: ACTIVE_COMPARATOR

Hypocaloric diet plan

Intervention Type: DIETARY_SUPPLEMENT

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.

Auricular Acupuncture

Intervention Type: OTHER

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.

only diet therapy

only diet therapy prescribed by a licensed nutritionist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Auriculotherapy; Auriculotherapy

Eligibility Criteria

Inclusion Criteria

• Adults
• Unfamiliar to acupuncture

Exclusion Criteria

• Psychotropic medication
• Psychiatric or thyroid disorders
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Andreia Vieira

OTHER

Sponsor Role: lead

Responsible Party

Andreia Vieira

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

uportoweightloss

Identifier Type: REGISTRY

Identifier Source: secondary_id

uportoweightloss

Identifier Type: -

Identifier Source: org_study_id