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OpenTrials
Completed

NCT Number: NCT04834180

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults
  • Unfamiliar to acupuncture

Exclusion criteria

  • Psychotropic medication
  • Psychiatric or thyroid disorders
  • Pregnancy

Treatment and study plan

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.

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.

Other names: Auriculotherapy

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.

Other names: Auriculotherapy

Primary outcomes

  1. Weight (kg)

    Time frame: 1 month

    TANITA® bio-impedance scale (model 762)

  2. Waist Perimeter (cm)

    Time frame: 1 month

    tape measure from SECA® (model 203)

  3. height (cm)

    Time frame: 1 month

    SECA® stadiometer (model 208)

  4. body fat (%)

    Time frame: 1 month

    TANITA® bio-impedance scale (model 762)

  5. Body mass index (kg/m2)

    Time frame: 1 month

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

  6. Waist-to-height ratio (cm2)

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Andreia Vieira

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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