Assessment of standard diet and Embedding Therapy on Anthropometric Indices, Ghrelin Levels , and Bioelectrical Impedance Analysis parameters in overweight and simple obesity individuals.

Investigation of the effect of embedding on weight reduction, anthropometric indices, ghrelin levels, and selected bioimpedance parameters in patients with overweight and non‑morbid obesity undergoing standard dietary treatment compared with a control group

The study includes two groups: a control group (diet only) and an embedding group (diet plus thread embedding). It is a single‑blind (assessors and analysts) parallel‑group clinical trial. The sample size is 30 participants in each group; considering possible attrition, 33 participants will be recruited for each group. Randomization will be performed using pre-prepared envelopes.

The study will be conducted at the Acupuncture Clinic of Imam Reza Hospital in Mashhad. To prevent selection bias, the standard technique of opaque, sealed envelopes will be used. Patients will be randomly assigned to either the intervention group (embedding plus diet) or the control group (diet only). Both groups will receive dietary intervention, and the embedding group will undergo one session of thread embedding.

Male or female patients aged 18–60 years Body mass index (BMI) between 28 and 40 Waist circumference greater than 90 cm in men and greater than 80 cm in women More than 6 months postpartum Blood pressure less than 140/90 mmHg No specific conditions that contraindicate acupuncture or embedding No use of weight‑loss medications No history of kidney and/or liver disease

Control group: Nutritional intervention (diet therapy) Embedding group: Nutritional intervention combined with thread embedding

Weight, body mass index , waist circumference, muscle mass, fat mass, phase angle, and serum ghrelin levels.

Block randomization with block sizes of 4 and 6 will be used. The random allocation sequence will be generated using a valid online tool (Randomization.com). To ensure allocation concealment, sequentially numbered, sealed envelopes will be employed. To prevent selection bias, the standard technique of opaque, sealed, and sequentially numbered envelopes will be applied. The allocation codes generated in the previous step will be written on cards by an individual independent of the research team and outcome assessors. These cards will then be placed inside opaque envelopes. The envelopes will be sealed and numbered sequentially from 1 to 64 according to the order of participant enrollment. After confirming eligibility criteria, finalizing participant enrollment, and obtaining informed consent, the next envelope in the sequence will be opened. Participants will then be assigned to either the intervention group (embedding plus diet) or the control group (diet only).

In this study, blinding was performed as single-blinding, meaning that the participants were unaware of their allocation to the study groups, while the assessors and data analysts were aware of the study conditions. Due to the nature of the intervention, complete blinding of all parties involved was not feasible.

The statistical details of the data will be mentioned in the published article.

After finishing the research

All individuals who have access to the published article or those who obtain permission from the Research Vice‑Chancellor of Mashhad University of Medical Sciences.

With the permission of the principal investigator and the approval of the University Research Council, and solely for informational purposes without any possibility of using or exploiting the data content.

After publication of the article, the data will be available to the corresponding author; before publication, if necessary, they may be provided to the principal investigator upon request by the relevant authorities.

By means of Vice research of Mashhad University of Medical Science