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

• ClinicalTrials.gov Identifier: NCT04834180
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Sponsor: Andreia Vieira
• Information provided by (Responsible Party): Andreia Vieira, Universidade do Porto

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.

Condition or disease	Intervention/treatment	Phase
Weight Loss; Abdominal Obesity	Dietary Supplement: Hypocaloric diet plan; Other: Auricular Acupuncture; Other: Acupressure	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Highest Weight Loss and Abdominal Adiposity Loss With Hypocaloric Diet Plan and Auricular Acupuncture
• Actual Study Start Date: April 1, 2015
• Actual Primary Completion Date: September 1, 2015
• Actual Study Completion Date: December 15, 2015

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: 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.	Dietary Supplement: 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.; 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.; Other Name: Auriculotherapy
Active Comparator: 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.	Dietary Supplement: 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.; Other: 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.; Other Name: Auriculotherapy
No Intervention: only diet therapy; only diet therapy prescribed by a licensed nutritionist.

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: adults
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Adults
• Unfamiliar to acupuncture

Exclusion Criteria:

• Psychotropic medication
• Psychiatric or thyroid disorders
• Pregnancy

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Andreia Vieira, Principal Investigator, Universidade do Porto
• ClinicalTrials.gov Identifier: NCT04834180
• Other Study ID Numbers: uportoweightloss; uportoweightloss ( Registry Identifier: uportoweightloss )
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity, Abdominal; Body Weight; Weight Loss; Body Weight Changes; Obesity; Overnutrition; Nutrition Disorders