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

Primary Purpose

Weight Loss, Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypocaloric diet plan
Auricular Acupuncture
Acupressure
Sponsored by
Andreia Vieira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults
  • Unfamiliar to acupuncture

Exclusion Criteria:

  • Psychotropic medication
  • Psychiatric or thyroid disorders
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Active Comparator

    No Intervention

    Arm Label

    Vaccaria seeds plus diet therapy

    ASP needles plus diet therapy

    only diet therapy

    Arm Description

    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 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.

    only diet therapy prescribed by a licensed nutritionist.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2021
    Last Updated
    April 2, 2021
    Sponsor
    Andreia Vieira
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04834180
    Brief Title
    Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
    Official Title
    Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    September 1, 2015 (Actual)
    Study Completion Date
    December 15, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Andreia Vieira

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss, Abdominal Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaccaria seeds plus diet therapy
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    ASP needles plus diet therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    only diet therapy
    Arm Type
    No Intervention
    Arm Description
    only diet therapy prescribed by a licensed nutritionist.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Hypocaloric diet plan
    Intervention Description
    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
    Other
    Intervention Name(s)
    Auricular Acupuncture
    Other Intervention Name(s)
    Auriculotherapy
    Intervention Description
    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
    Intervention Name(s)
    Acupressure
    Other Intervention Name(s)
    Auriculotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Weight (kg)
    Description
    TANITA® bio-impedance scale (model 762)
    Time Frame
    1 month
    Title
    Waist Perimeter (cm)
    Description
    tape measure from SECA® (model 203)
    Time Frame
    1 month
    Title
    height (cm)
    Description
    SECA® stadiometer (model 208)
    Time Frame
    1 month
    Title
    body fat (%)
    Description
    TANITA® bio-impedance scale (model 762)
    Time Frame
    1 month
    Title
    Body mass index (kg/m2)
    Description
    Body mass index is defined as the body mass divided by the square of the body height.
    Time Frame
    1 month
    Title
    Waist-to-height ratio (cm2)
    Description
    The WHTR was obtained by dividing the waist circumference (cm) by height (cm).
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    adults
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults Unfamiliar to acupuncture Exclusion Criteria: Psychotropic medication Psychiatric or thyroid disorders Pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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

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