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

Not Applicable

Completed

• Conditions: Weight Loss; Abdominal Obesity
• Interventions: Dietary Supplement: Hypocaloric diet plan; Other: Auricular Acupuncture; Other: Acupressure

• Registration Number: NCT04834180
• Lead Sponsor: Andreia Vieira

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).

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2015-09-01
• Study Completion: 2015-12-15
• Study First Submitted: 2021-03-31
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-02
• Last Update Submitted: 2021-04-02
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Adults
• Unfamiliar to acupuncture

Exclusion Criteria

• Psychotropic medication
• Psychiatric or thyroid disorders
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccaria seeds plus diet therapy	Hypocaloric diet plan	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.
ASP needles plus diet therapy	Auricular Acupuncture	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.
Vaccaria seeds plus diet therapy	Acupressure	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.
ASP needles plus diet therapy	Hypocaloric diet plan	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.

Primary Outcome Measures

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