Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001401842p
Ethics application status
Submitted, not yet approved
Date submitted
1/09/2021
Date registered
18/10/2021
Date last updated
18/10/2021
Date data sharing statement initially provided
18/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Light acupuncture for people with prediabetes: experiences, benefits and safety
Scientific title
Effects and experience of light acupuncture for people with prediabetes: a pilot, randomized and feasibility Study
Secondary ID [1] 305200 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 323473 0
Condition category
Condition code
Metabolic and Endocrine 321033 321033 0 0
Diabetes
Alternative and Complementary Medicine 321034 321034 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will involve a 1-week run-in period, a 3-week intervention period, a 1-week washout in between intervention period, then a three-month follow-up. All participants in the intervention group will receive a light acupuncture treatment from a licensed acupuncturist at ECU Acupuncture Research Clinic. The treatment will involve a light acupuncture treatment (30-40 min/session, 5 sessions/week) for 3 weeks, within a total of 15 sessions. Each session includes preparation, treatment, and conclusion of the session. A 3B Laser Pen (manufacturer livetec GmbH, Marie-Curie-Str. 8, 79539 Lörrach, Germany) with the output power of 200mW and a wavelength of 808 nm will be applied to bare skin on the selected points. Each acupoint will receive 20 seconds of energy (4J), with 20 minutes being the maximum treatment time (240J). A standardised protocol for all participants will be used. The treatment points for light acupuncture are as follows: 1) Acupoints on the back: Pi Shu (BL-20), Shen Shu (BL-23), Wei Shu (BL-21), Gan Shu (BL-18), Weiwanxiashu (EX-B3), Fei Shu (BL-13), and Yi Shu (EX-B5); 2) Abdominal acupoints: Tian Shu (ST-25), Zang Men (LR 13) and Shen Que (RN8);3) Lower leg acupoints: Zu San Li (ST36), San Yin Jiao (SP-6), and Tai Xi (KI 3). During the trial process, we will use an observational sheet to monitor the adherence to the intervention.
Intervention code [1] 321602 0
Prevention
Intervention code [2] 321603 0
Treatment: Other
Comparator / control treatment
Participants randomized to the no treatment arm will keep receiving whatever care is available to them in their community or primary care, for example, exercise, diet, weight control, and quitting smoking. The self-reported care received by the participants in the no-treatment arm will be documented during the trial process.
Control group
Active

Outcomes
Primary outcome [1] 328809 0
The recruitment and completion rate will be assessed via an observational sheet. This will be assessed as a composite outcome. The recruitment rate will be calculated by No. consented/eligible, while the completion rate will be assessed by No. completed/enrolled.
Timepoint [1] 328809 0
Recruitment and completion rates will be assessed at the conclusion of the study.
Primary outcome [2] 328810 0
The acceptability of the intervention (participants’ compliance and adherence; participants’ attitudes, motivation, and challenges to participation) will be assessed as a composite outcome. Participants’ compliance and adherence will be assessed by No. completed sessions/No. of sessions via an observational sheet. Participants’ attitudes, motivation, and challenges to participation, reasons for withdrawal, missed sessions, non-compliance with the intervention, and experiences during trial participation will be investigated via a study-specific online survey and a face to face conversation.
Timepoint [2] 328810 0
An observational sheet will be monitored during the interventions during the treatment (week 1-3, week 5-7). A face-to-face conversation with open-ended questions will be investigated during the interventions before the treatment (week 1-3, week 5-7). Study-specific online surveys will be assessed at baseline (week 0), post-three weeks intervention (week 3), after the washout period (following crossover) (week 4), and post-three weeks intervention (week 7).
Primary outcome [3] 328811 0
The practicality of the intervention (3-monthly out of pocket cost (OOP) for the prediabetes therapies; past 3-month choice of non-drug therapy) will be investigated via a study-specific online survey. This will be assessed as a composite outcome.
Timepoint [3] 328811 0
This outcome will be assessed at baseline (week 0) and at the conclusion of the study.
Secondary outcome [1] 400493 0
Prediabetes risk test (PRT)
Timepoint [1] 400493 0
The outcome of PRT will be measured before enrollment (week -1), post-three weeks intervention (week 3), after the washout period (following crossover) (week 4), post-three weeks intervention (week 7), and follow-up period (week 19).
Secondary outcome [2] 400494 0
The Finnish diabetes risk score (FINDRISC) questionnaires
Timepoint [2] 400494 0
The outcome of FINDRISC will be measured using four online surveys: at baseline (Week 0), post-three weeks intervention (week 3), after the washout period (following crossover) (week 4), post-three weeks intervention (week 7), and follow-up period (week 19).
Secondary outcome [3] 400495 0
Blood glucose level, as evaluated by fasting plasma glucose (FPG), and 2-h plasma glucose (2hPG).
Timepoint [3] 400495 0
The results of blood glucose level test will be collected at baseline (week 0), post-three weeks intervention (week 3), after the washout period (following crossover) (week 4), and post-three weeks intervention (week 7).
Secondary outcome [4] 400496 0
Safety assessments will be monitored and documented by the number of incidences and the severity of the adverse events related to light acupuncture.

Timepoint [4] 400496 0
This outcome will be assessed during the interventions (week 1-3, week 5-7).
Secondary outcome [5] 401334 0
Quality of life (QOL), as evaluated by the Medical Outcomes Study Short-Form version 2 (SF-12v2).
Timepoint [5] 401334 0
The outcome of SF-12v2 will be measured using four online surveys: at baseline (Week 0), post-three weeks intervention (week 3), after the washout period (following crossover) (week 4), post-three weeks intervention (week 7), and follow-up period (week 19).

Eligibility
Key inclusion criteria
Participants are eligible for this study if they meet the diagnosis criteria for prediabetes and or are scored 5 or higher on the Prediabetes Risk Test.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have a greater kidney or endocrine disease, or comorbidities, or mental illness, or pregnant, preparation for pregnancy or breastfeeding or participate in another clinical trial within the last two weeks will not be eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequence numbers of each participant will be generated by a computer-produced random list, performed by an independent, blinded statistical expert.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated via a simple randomization method by an independent, blinded statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the primary outcome, descriptive statistics for categorical data will be the primary analysis. We will use frequencies and proportion (%) to analyze the demographic data, recruitment rate (no. consented/eligible) and completion rate (No. completed/enrolled), participants’ compliance and adherence (completed sessions/no. of sessions), OOP, predicted cost for LA, and the past 3-month choice of non-drug therapy. Visualization tools such as boxplots and histograms will be used to identify trends and potential outliers (if any).

The qualitative data to characterize the acceptability metrics collected via open-ended questions will be used to help explain or elaborate on the quantitative data. The qualitative data, such as participants’ attitudes, motivation and challenges to participation, reasons for withdrawal, missed sessions, non-compliance with intervention, and experiences during trial participation, will be analyzed using template thematic analysis. ‘A priori’ code frame (a hierarchical set of themes used in coding qualitative data) will be used to analyze and report on the data.

Descriptive statistics, such as mean and standard deviation (SD) for normally distributed data, median and interquartile range (IQR) for non-normally distributed data, frequency and proportion (%) for categorical data, will be used to describe data distribution for the secondary outcomes. A mixed-model ANOVA will be used to assess differences between and within-group in the scores of PRT, FINDRISC, and SF-12v2, and the level of FPG and 2hPG. Bonferroni post-hoc test will be deployed to assess pairwise differences between- and within groups. Gender, age, and other relevant confounding factors will be adjusted for in all models. Based on identified aims and hypotheses, an intent-to-treat principle will be performed. Data analysis will be performed with the SPSS statistical software system, version 27.0 (SPSS Inc., Chicago, IL, USA). Results are deemed significant if p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 309579 0
University
Name [1] 309579 0
Edith Cowan University
Country [1] 309579 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 310594 0
None
Name [1] 310594 0
None
Address [1] 310594 0
None
Country [1] 310594 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309357 0
Edith Cowan University’s Human Research Ethics Committee
Ethics committee address [1] 309357 0
Ethics committee country [1] 309357 0
Australia
Date submitted for ethics approval [1] 309357 0
28/08/2021
Approval date [1] 309357 0
Ethics approval number [1] 309357 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113882 0
A/Prof Min Zhang
Address 113882 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 113882 0
Australia
Phone 113882 0
+61 8 63043589
Fax 113882 0
Email 113882 0
[email protected]
Contact person for public queries
Name 113883 0
Min Zhang
Address 113883 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 113883 0
Australia
Phone 113883 0
+61 8 63043589
Fax 113883 0
Email 113883 0
[email protected]
Contact person for scientific queries
Name 113884 0
Min Zhang
Address 113884 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 113884 0
Australia
Phone 113884 0
+61 8 63043589
Fax 113884 0
Email 113884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.