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

NCT04834180 | Completed

• 1 other identifier: uportoweightloss
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Loss; Abdominal Obesity

Outcome Measures

Primary Outcomes (6)

• Weight (kg)

  TANITA® bio-impedance scale (model 762)

  1 month

• Waist Perimeter (cm)

  tape measure from SECA® (model 203)

  1 month

• height (cm)

  SECA® stadiometer (model 208)

  1 month

• body fat (%)

  TANITA® bio-impedance scale (model 762)

  1 month

• Body mass index (kg/m2)

  Body mass index is defined as the body mass divided by the square of the body height.

  1 month

• Waist-to-height ratio (cm2)

  The WHTR was obtained by dividing the waist circumference (cm) by height (cm).

  1 month

Study Arms (3)

Vaccaria seeds plus diet therapy

SHAM COMPARATOR

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.

Dietary Supplement: Hypocaloric diet plan; Other: Acupressure

ASP needles plus diet therapy

ACTIVE COMPARATOR

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.

Dietary Supplement: Hypocaloric diet plan; Other: Auricular Acupuncture

only diet therapy

NO INTERVENTION

only diet therapy prescribed by a licensed nutritionist.

Interventions

Hypocaloric diet plan 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.

ASP needles plus diet therapy; Vaccaria seeds plus diet therapy

Auricular Acupuncture 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.

Also known as: Auriculotherapy

ASP needles plus diet therapy

Acupressure 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.

Also known as: Auriculotherapy

Vaccaria seeds plus diet therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: adults
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Unfamiliar to acupuncture

You may not qualify if:

• Psychotropic medication
• Psychiatric or thyroid disorders
• Pregnancy

Sponsors & Collaborators

• Andreia Vieira: lead

MeSH Terms

Conditions

Weight Loss; Obesity, Abdominal

Interventions

Acupuncture, Ear; Auriculotherapy; Acupressure

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 15, 2015
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR