NCT01167348

Brief Summary

The purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

July 16, 2010

Last Update Submit

July 22, 2010

Conditions

Keywords

auricular acupressureobesityschizophreniabody weight

Outcome Measures

Primary Outcomes (1)

  • Using Body weight scale (kilogram) and checking body weight for all participants

    all participants are going to be measured body weight per week for 2 months.

    2 months

Secondary Outcomes (2)

  • waist circumference

    2 months

  • Fat percentage by using bio-Impedance Analysis(Tanita-519 machine)

    2 months

Interventions

Investigator will put a tape with a 0.5mmx0.5mm seed on the specific positions on the ear of participants of intervention group, and participants will be asked to press these specific positions 3 times a day.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ICD:295,living in chronic ward for more than 2 month
  • Body Mass Index (BMI) \>or=24
  • Age between 20 to 60
  • Psychotic status stable and can communicate

You may not qualify if:

  • Unstable psychotic status
  • Participants who have endocrine disease
  • Participants who have cardiac disease
  • Participants who have immunological disease
  • Participants who have liver or renal function impairment
  • Pregnant woman or in milking stage
  • Cerebrovascular accident (CVA) stroke and disability
  • Participant who attends weight control programs in recent 3 months
  • Any conditions that clinical doctors refuse to let join in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsao-Tun Psychiatric Center

Nantou City, Taiwan

RECRUITING

MeSH Terms

Conditions

SchizophreniaObesityBody Weight

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ching Han-Yi, MD

    Tsaotun Psychiatric Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 22, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations