Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000896875
Ethics application status
Approved
Date submitted
21/08/2012
Date registered
22/08/2012
Date last updated
22/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for weight loss and mental health
Scientific title
Does acupuncture promote weight loss and mental health in overweight and obese individuals participating in a weight loss program? A randomised cross-over study
Secondary ID [1] 281068 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 287215 0
Condition category
Condition code
Mental Health 287543 287543 0 0
Other mental health disorders
Alternative and Complementary Medicine 287547 287547 0 0
Other alternative and complementary medicine
Diet and Nutrition 287548 287548 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a single blinded randomised cross over design study was used
The intervention phases was;
a) Nutritional counselling plus Traditional Chinese Medicine(TCM) acupuncture

The treatment phase was six weeks in duration with each participant receiving weekly nutritional counselling and twice weekly acupuncture (either sham or TCM acupuncture). There was a two week wash-out period between the two treatment phases.

Treatment
Nutritional Counselling: Participants were provided with weekly lifestyle counselling during both phases of treatment. Nutritional counselling was provided by final year undergraduate nutrition students at the Victoria University nutrition teaching clinic in Melbourne, Australia. The nutrition teaching clinic was supervised by an experienced dietician and nutritionist.

The treatment provided was structured in such a way that participants were encouraged to follow the Dietary guidelines for Australians. This entailed prescribing a moderate carbohydrate (approximately 55% total energy), low fat (approximately 25-30%) and moderate protein (approximately 15-20%) diet. All treatment providers for the nutritional counselling were blind to the type of acupuncture the participants were receiving.

Acupuncture: TCM style manual acupuncture was used in the study. Point selection was based on a list of points previously reported as being effective in weight loss and mental health. Electro-acupuncture has been shown to be effective in recent weight loss studies however its unknown effect on mental health and in particular, eating and weight concerns, excluded its use in this study.

All participants received needling at the same prescribed acupoints at each acupuncture session; Bilateral Hegu (LI 4), Quchi (LI 11), Zusanli (ST 36), Neiting (ST 44), Taichong (LR 3). All acupoints were located according to A Manual of Acupuncture (Deadman, et al., 1998). In addition three auricular acupoints were unilaterally needled on one ear; Unilateral Hungry, Stomach and Shen Men with the side being alternated every succeeding treatment.

The treatment was administered by one of the researchers (SF), an experienced acupuncture practitioner of eight years. Needling depth varied between 0.5 to 1.5 cm for sites across the body (both TCM acupuncture and sham) and was dependent on the thickness of the skin and subcutaneous fatty tissue. Single use sterilised needles (AcuGlide brand, 40 mm (0.20 or 0.25mm diameter) were used for the body acupuncture and 10 mm (0.16mm diameter) for the auricular acupuncture. Following insertion, halfway during the treatment and just prior to the needles being removed, the needles were manipulated using a gentle lift/thrust and rotation which has a homeostatic/supplementing effect. The needles were retained in situ for 30 minutes after which they were removed. To conceal the TCM acupuncture from the sham, vigorous needle manipulation was not employed. The sensation of de qi was not specifically elicited. No other interventions were co-administered. A small number of participants (less than 10 percent) reported slight pain on needle insertion and mild bruising following acupuncture.
Intervention code [1] 285523 0
Treatment: Other
Comparator / control treatment
a single blinded randomised cross over design study was used
The control phases was;
b) Nutritional counselling plus sham acupuncture (acupuncture at non-acupuncture sites in close proximity to the acupuncture points used for weight loss).

The treatment phase was six weeks in duration with each participant receiving weekly nutritional counselling and twice weekly acupuncture (either sham or TCM acupuncture). There was a two week wash-out period between the two treatment phases.

Nutritional Counselling: Participants were provided with weekly lifestyle counselling during both phases of treatment. Nutritional counselling was provided by final year undergraduate nutrition students at the Victoria University nutrition teaching clinic in Melbourne, Australia. The nutrition teaching clinic was supervised by an experienced dietician and nutritionist.

The treatment provided was structured in such a way that participants were encouraged to follow the Dietary guidelines for Australians. This entailed prescribing a moderate carbohydrate (approximately 55% total energy), low fat (approximately 25-30%) and moderate protein (approximately 15-20%) diet. All treatment providers for the nutritional counselling were blind to the type of acupuncture the participants were receiving.
Sham Acupuncture
All participants received bilateral needling at the same sham sites at each sham acupuncture session. These sites were located close to the acupuncture points listed above. Pseudo Hegu (LI 4) was located on the ulna side of the dorsal aspect of the thumb at the distal end of the first metacarpal joint, pseudo Quchi (LI 11) was located one cun lateral to Quchi (LI 11), pseudo Zusanli (ST 36) was located 3-4 cun below Yánglíngquán (GB 34) on the anterior border of the fibula, pseudo Neiting (ST 44) was located at the proximal medial aspect of the fourth tarsal bone, pseudo Taichong (LR 3) is located on the medial aspect of the tendon of the Extensor Hallicus Longus muscle, level with Taichong (LR 3). In addition three irrelevant auricular acupoints were needled; External Nose for Hungry, Thorax (chest) for Stomach and Hip joint for Shen Men. Similar to the acupuncture phase each ear was alternated every session.

There have been reports of issues related to invasive sham needling including greater therapeutic effects than conventional placebos and the therapeutic effect of the practitioner. The nature of a randomised cross-over study counteracts these issues with all participants receiving the same practitioner interaction and care during the invasive and real acupuncture treatments and all participants receiving both treatments.
Control group
Placebo

Outcomes
Primary outcome [1] 287785 0
The primary outcome measure was body weight change (kg and percentage).
Timepoint [1] 287785 0
Body weight was measured weekly (1-6 and then 8-14), on digital scales (Tanita, USA) in kilograms with 0.1kg graduations.
Secondary outcome [1] 298833 0
Secondary outcome measures were the validated Eating Disorder Inventory-3 (EDI-3, EDRC scale).
Timepoint [1] 298833 0
Each questionnaire was administered prior to randomisation, at the completion of the first phase of treatment and at the beginning and end of the second phase of treatment.
Secondary outcome [2] 298834 0
the Becks Depression Inventory (BDI-2).
Timepoint [2] 298834 0
Each questionnaire was administered prior to randomisation, at the completion of the first phase of treatment and at the beginning and end of the second phase of treatment.
Secondary outcome [3] 298835 0
the State-Trait Anxiety Inventory (STAI).
Timepoint [3] 298835 0
Each questionnaire was administered prior to randomisation, at the completion of the first phase of treatment and at the beginning and end of the second phase of treatment.
Secondary outcome [4] 298836 0
the SF-36v2 Health Survey (physical and mental quality of life).
Timepoint [4] 298836 0
Each questionnaire was administered prior to randomisation, at the completion of the first phase of treatment and at the beginning and end of the second phase of treatment.

Eligibility
Key inclusion criteria
Inclusion criteria included: a BMI of 25 to 40 at enrollment of the study (all participants’ commenced treatment within four weeks of enrolling); stable body weight three months prior to enrolling in the study and the ability to give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded if they were: less than 18 years of age; seeking other weight loss treatment outside the study; diagnosed with a serious concomitant illness such as heart disease or endocrine disease; pregnant or had given birth within the last six months; diagnosed with Polycystic Ovarian Syndrome or provided with medical treatment that may have had nutritional implications on weight or appetite or their ability to comply with the study.

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)
Men and women who were overweight or obese (defined by the Body Mass Index (BMI) (weight (kgs)/height (m)2) were recruited via an internal mail release at Victoria University, Melbourne, Australia between June 2008 to June 2009. Participants were allocated to each group using a random number generator. Sarah Fogarty meet with all potential participants to see if they were eligable for the study. If the participants were eligable then Sarah obtained consent and enrolled them into the study. Sarah was blind to the allocation of order of which the treatments were to be undertaken. Sarah contacted another reseracher who was interstate (off-ste) after the participant enrolled and was the holder of the allocation schedule and she was told the order of the treatments. All other reserachers, e.g. the nutritionists, the supervisors were blind to the treatment order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were allocated to each group using a random number generator. All treatment providers and the researcher enrolling the participants into the study (SF) were blind to the assignment of order of the phases
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285859 0
Self funded/Unfunded
Name [1] 285859 0
None
Country [1] 285859 0
Primary sponsor type
University
Name
Victoria Univeristy
Address
School of Biomedical and Health Sciences
Victoria University, St Albans Campus
PO Box 14428
Melbourne Vic 8001
Country
Australia
Secondary sponsor category [1] 284679 0
None
Name [1] 284679 0
Address [1] 284679 0
Country [1] 284679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287873 0
The study was approved by the Victoria University Human Research Ethics Committee
Ethics committee address [1] 287873 0
Ethics committee country [1] 287873 0
Australia
Date submitted for ethics approval [1] 287873 0
15/05/2008
Approval date [1] 287873 0
27/06/2008
Ethics approval number [1] 287873 0
No. HRETH 08/85

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

Contacts
Principal investigator
Name 34600 0
Address 34600 0
Country 34600 0
Phone 34600 0
Fax 34600 0
Email 34600 0
Contact person for public queries
Name 17847 0
Sarah Fogarty
Address 17847 0
PO Box 339
Chadstone Centre
Victoria 3148
Country 17847 0
Australia
Phone 17847 0
+61 405078914
Fax 17847 0
Email 17847 0
[email protected]
Contact person for scientific queries
Name 8775 0
Sarah Fogarty
Address 8775 0
PO Box 339
Chadstone Centre
Victoria 3148
Country 8775 0
Australia
Phone 8775 0
+61 405078914
Fax 8775 0
Email 8775 0
[email protected]

No information has been provided regarding IPD availability


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.