Previously submitted to: JMIR Research Protocols (no longer under consideration since Jul 30, 2026)
Date Submitted: Dec 12, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The effect and safety of acupoint thread embedding in treatment of overweight and obese women: study protocol of a randomized controlled trial
ABSTRACT
Background:
Obesity is a major health concern over the world, affecting female’s physical and psychological health. Acupoint thread embedding (ATE) treatment is an innovative method based on Traditional Chinese Medicine (TCM) theories and can provide long term stimulation on acupoints. However, its efficacy for weight-loss among female patients remains questionable primarily due to insufficient high-level evidence.
Objective:
The aim of this study is to provide solid and objective evidence about the effect and safety of ATE on the treatment among female patients with overweight and obesity.
Methods:
This is a patient-assessor-blinded, randomized, sham controlled clinical trial that will conduct in a TCM hospital. A total of 132 eligible participants will be randomly assigned to either group, receiving ATE with health education or sham ATE with health education. Participants will receive 6 sessions of real or sham ATE intervention once in every 2 weeks for 12 weeks, with an additional 12 weeks of follow-up period. Primary outcome will be the change of body mass index between baseline and end of treatment. Secondary outcomes will include changes in the body weight, waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, body fat percentage measured by body composition analyzer, liver stiffness measured by liver elastography, self-rated questionnaires including Impact of Weight on Quality-of-Life-Lite Scale, Visual Analogue Scale of appetite, Well-Being Index and Hamilton Rating Scale for Anxiety, and blood tests results about glucolipid metabolism. All adverse events will be assessed by the treatment emergent symptom scale. Outcomes will be collected at baseline, week 6, week 12 and week 24 during the intervention and follow-up.
Results:
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Conclusions:
/ Clinical Trial: The study has been registered at ClinicalTrials.gov (Identifier: NCT06316310, registered on March 15, 2024).
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