Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000972325
Ethics application status
Approved
Date submitted
13/06/2017
Date registered
6/07/2017
Date last updated
6/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Surveying the health of women associated with Universal Medicine
Scientific title
A cross-sectional health survey of 407 women associated with Universal Medicine
Secondary ID [1] 292180 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BMI 303627 0
Stress 303628 0
Depression 303629 0
Summary Mental Health 303632 0
Abnormal pap test 303633 0
Low iron 303634 0
Abnormal mammogram 303635 0
Asthma 303636 0
Bronchitis / Emphysema 303637 0
Breast cancer 303638 0
Cervical cancer 303639 0
Heart disease 303640 0
Osteoporosis 303641 0
Skin cancer 303642 0
Stroke 303643 0
Diabetes 303644 0
Hypertension 303645 0
Thrombosis 303646 0
Back pain 303647 0
Condition category
Condition code
Public Health 303036 303036 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The survey's name is "Women in Livingness Survey". It is a one-off 1 hour survey participants fill in on the survs survey platform www.survs.com. The survey contains both questions designed specifically for this survey and questions from the ALSWH (Australian Longitudinal Study of Women's Health).

There were no conditions observed beyond the ones asked about in the survey. The participants were exposed to an online platform where they indicated their consent. If they consented, there were progressively given the questions of the survey to answer in a standard internet survey format, having the ability to go back and forth between pages and answering multiple-choice type questions.
Intervention code [1] 298332 0
Not applicable
Comparator / control treatment
The data of the Universal Medicine participants was collected on the online survey platform between July 4th, 2015 and September 5th, 2015.

The survey results are compared with the summary survey results from the Australian Longitudinal Study of Women's Health (ALSWH). The summary survey results can be downloaded from the ALSWH website: https://www.alswh.org.au/for-researchers/data/data-books. The ALSWH data covers surveys from 1998 to 2013.
Control group
Historical

Outcomes
Primary outcome [1] 302409 0
SF-36 scores
Timepoint [1] 302409 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Primary outcome [2] 302445 0
Symptoms: Allergies, hayfever, sinusitis; Breathing difficulty; Indigestion / heartburn; Chest pain; Headaches / migraines; Severe tiredness; Stiff or painful joints; Back pain; Urine that burns or stings; Haemorrhoids (piles); Other bowel problems; Vaginal irritation or unusual discharge; Hot flushes; Night sweats; Eyesight problems; Leaking urine; Mouth, teeth or gum problems; Avoided eating some foods because of problems with your teeth, mouth or dentures; Toothache; Hearing problems; Depression; Anxiety; Episodes of intense anxiety (eg panic attacks); Palpitations (feeling that your heart is racing or fluttering in your chest)

All symptoms were assessed by asking how often the respondent experienced the symptom in the previous 12 months: Never, rarely, sometimes or often. All questions were copied from the ALSWH survey.
Timepoint [2] 302445 0
In the 12 months prior to the survey and, from memory, in the 12 months prior to them attending their first Universal Medicine event.
Primary outcome [3] 302446 0
Medical history: Whether respondent ever been diagnosed for any of 28 ailments: Insulin dependent (Type 1) diabetes; Non-insulin dependent (Type 2) diabetes; Hyperthyroidism (Overly active thyroid); Hypothyroidism (Under active thyroid); Impaired glucose tolerance; Osteoarthritis; Rheumatoid arthritis; Other arthritis; Heart disease (including heart attack, angina); Hypertension (high blood pressure); Thrombosis; Stroke; Low iron level (iron deficiency or anaemia); Asthma; Bronchitis / emphysema; Osteoporosis; Endometriosis; Polycystic Ovary Syndrome; Breast cancer; Cervical cancer; Skin cancer (including melanoma); Other cancer; Depression; Anxiety / nervous disorder; Other psychiatric disorder; Chronic Fatigue Syndrome; Sexually transmitted infection (eg genital herpes or warts, chlamydia); Polyps or Fibroids related to female organs.

Whether any of 17 operations or procedures had ever been performed: A non-cancerous cyst removed; Polyps or fibroids related to female organs removed; Thyroid removed; One but not both ovaries removed; Both ovaries removed; Repair of prolapsed vagina, bladder or bowel?; Endometrial ablation (removal of the lining of the uterus); Joint replacement (eg hip, knee); Mastectomy (removal of one or both breasts); Lumpectomy (removal of lump from breasts); Removal of skin cancer; Any cancer surgery (other than skin or breast); Chemotherapy or radiotherapy for any cancer; Breast biopsy (taking a sample of breast tissue); Hysteroscopy (investigative procedure to examine the uterus); Cholecystectomy (gall bladder removed); Gastroscopy / colonoscopy.

Also: Whether respondents ever had an abnormal pap test or mammogram or hysterectomy. Whether respondents take the contraceptive pill or hormone replacement therapy or had a recent menstrual bleeding, whether the frequency of their periods has changed in the previous 12 months, start and stop age of menstrual bleeding. Condition of teeth dentures or gums.

These items were asked asked through a Yes/No response in the survey. All questions were copied from the ALSWH survey.
Timepoint [3] 302446 0
From birth up to the time of the survey
Secondary outcome [1] 335890 0
CESD (Depression) Scale
Timepoint [1] 335890 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [2] 336026 0
Perceived Control Scale
Timepoint [2] 336026 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [3] 336027 0
Questions re menstrual health issues in the previous 12 months. These questions had little or no overlap with ALSWH questions. Respondents answered three different sets of questions depending on whether they were in menses, perimenopausal or menopausal.

Menopausal questions:
Ovarian Pain or Cramps; Abdominal Cramps; Endometriosis; Very sensitive, tender or sore breasts; Tiredness, worse than in the past; Exhaustion; A desire to have more order in my life; Pre-full moon tension but few people notice; Pre-full moon tension noticed by many; Feeling bloated; Hot flushes; Sudden sweats during the day; Weight gain; Emotional or sad; Feeling dizzy or faint; Food or drink cravings; Nausea or vomiting; Feeling uncomfortable in the presence of others more frequently; Difficulty concentrating; Being more forgetful at times; Feeling anxious; Having bursts of energy; Having back aches; Mood swings - rapid changes in how you feel; Headaches; Pimples, dry skin, greasy skin, erratic skin in general.

Perimenopausal:
Ovarian Pain or Cramps; Abdominal Pain; Abdominal Cramps; Endometriosis; Painful periods; Heavy periods; Heavy periods that are worse than before; Heavy periods that last longer than before; Normal periods that last longer than before; Period cycles that are substantially longer than in the past; Irregular period cycles; Very sensitive, tender or sore breasts; Tiredness, worse than in the past; Exhaustion; A desire to have more order in my life; Pre-menstrual tension but few people notice; Pre-menstrual tension noticed by many; Feeling bloated; Hot flushes; Sudden sweats during the day; Feeling relief or appreciation when my periods arrive; Feeling upset or disappointed when my periods arrive; Weight gain; Crying for no reason; Feeling dizzy or faint; Food or drink cravings; Nausea or vomiting; Trouble breathing.

Menses:
Abdominal Cramps; Endometriosis; Painful periods; Heavy periods; Skipped periods; Heavy clotting, slight clotting; Constipation and other unusual bowel movements; Swollen breasts; Very sensitive, tender or sore breasts; Severe tiredness; Exhaustion; Tired or aching legs; A desire for everything to be neater and more tidy; Pre-menstrual tension but few people noticed; Pre-menstrual tension noticed by many; Intense irritation with others; Feeling bloated; Feeling bothered or inconvenienced by my periods; Feeling controlled by my periods; Weight gain; Emotional or sad; Feeling dizzy or faint; Food or drink cravings; Nausea or vomiting.

These items were collected by the respondents being asked whether they had these symptoms in the previous 12 months "Yes, definitely"; "Yes, sometimes"; "No, not much"; "No, not at all"
Timepoint [3] 336027 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [4] 336028 0
Kessler-10 Psychological Distress Scale
Timepoint [4] 336028 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [5] 336032 0
Visits to health practitioners in the previous 12 months, duplicating items from the ALSWH. For doctors frequency of visits, for other practitioners Yes/No:
A family doctor or another General Practitioner (GP); A hospital doctor (eg in outpatients or casualty); A specialist doctor; Physiotherapist; Counsellor / Psychologist / Social worker; A community nurse, practice nurse, or nurse practitioner; Optician / Optometrist; Dietitian; Podiatrist; Massage therapist; Naturopath / Herbalist; Chiropractor; Osteopath; Acupuncturist; Other alternative health practitioner (eg aromatherapist, homeopath, reflexologist, iridologist); An Esoteric Practitioner
Timepoint [5] 336032 0
In the 12 months prior to the survey and, from memory, in the 12 months prior to them attending their first Universal Medicine event.
Secondary outcome [6] 336033 0
BMI
Timepoint [6] 336033 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [7] 336034 0
History of weekly alcohol usage, question designed specifically for this survey:
In each life decade - nil, 1-7, 8-14, 15+; 12 months before attending their first Universal medicine event.
Current usage, copied from ALSWH: > 1 per day, 1 per day, 1-6 times per week, < once per week, not for past 12 months, not for past five years.
Timepoint [7] 336034 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [8] 336035 0
Sleep quality questionnaire as copied from ALSWH which used questions from the Nottingham health profile sleep subscale.
Timepoint [8] 336035 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [9] 336037 0
Weight loss strategies employed in the previous 12 months. This was done through the respondents answering the following questions on a Yes/No basis. These questions were copied from the ALSWH survey:
Commercial weight loss programs (eg Weight Watchers, Lite n' Easy, Sureslim, Jenny Craig); Meal replacements or slimming products (eg OPTIFAST, Herbalife); Exercise; Cut down on the size of meals or between meal snacks; Cut down on fats (low fat) and / or sugars; Low glycaemic index (GI) diet; Diet book diets (eg Atkins, Zone, CSIRO diet, Liver Cleansing diet); Laxatives, diuretics or diet pills (eg Xenical, Reductil); Fasting; Smoking; Other
Timepoint [9] 336037 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [10] 336040 0
Tobacco consumption as per ALSWH question: Daily; At least weekly (but not daily); Less often than weekly; Not at all
Timepoint [10] 336040 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [11] 336042 0
Weekly time spent on activities as per ALSWH question:
Full time paid work; Part-time paid work; Casual paid work; Home duties (own / family home); Work without pay (eg family business); Looking for work; Unpaid voluntary work; Active leisure (eg walking, exercise,; sport); Passive leisure (eg TV, music, reading,; relaxing); Studying
Timepoint [11] 336042 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [12] 336047 0
Feeling rushed questionnaire as employed by ALSWH surveys.
Timepoint [12] 336047 0
At the time of the survey and, from memory, at the time of them attending their first Universal Medicine event.
Secondary outcome [13] 336541 0
This question was designed for this survey, with the respondents responding to a question for the current usage of the below > 1 per day, 1 per day, 1-6 times per week, < once per week, not for past 12 months, not for past five years:

Coffee, tea, energy drinks or anything with caffeine; Items with added or concentrated sugar in it (sweets, mints, cakes, biscuits,; chewing gum, ice cream, flavoured yoghurt, healthbars, chocolate, dried fruit,; lemonade or soda, coffee, tea or other); Salty foods (crisps, salted nuts or similar); Dairy (cheese, yoghurt, ice cream, milk, butter, cream even if part of another dish; like cheeseburger or many cakes); Alcohol (beer, wine, spirits)
Timepoint [13] 336541 0
At the time of filling in the survey.

Eligibility
Key inclusion criteria
Participant in Universal Medicine workshops and lectures
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Summary analysis, regression analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/07/2015
Date of last participant enrolment
Anticipated
Actual
5/09/2015
Date of last data collection
Anticipated
Actual
5/09/2015
Sample size
Target
500
Accrual to date
Final
407
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8963 0
New Zealand
State/province [1] 8963 0
Country [2] 8964 0
United Kingdom
State/province [2] 8964 0
Country [3] 8965 0
Portugal
State/province [3] 8965 0
Country [4] 8966 0
Germany
State/province [4] 8966 0
Country [5] 8967 0
Belgium
State/province [5] 8967 0
Country [6] 8968 0
Japan
State/province [6] 8968 0
Country [7] 8971 0
Netherlands
State/province [7] 8971 0
Country [8] 8972 0
Norway
State/province [8] 8972 0
Country [9] 8973 0
United States of America
State/province [9] 8973 0
Country [10] 8974 0
Switzerland
State/province [10] 8974 0
Country [11] 8975 0
Canada
State/province [11] 8975 0
Country [12] 8976 0
Hong Kong
State/province [12] 8976 0
Country [13] 8977 0
Singapore
State/province [13] 8977 0
Country [14] 8978 0
Spain
State/province [14] 8978 0
Country [15] 8979 0
Colombia
State/province [15] 8979 0

Funding & Sponsors
Funding source category [1] 296716 0
Self funded/Unfunded
Name [1] 296716 0
Christoph Schnelle
Country [1] 296716 0
Australia
Primary sponsor type
Individual
Name
Christoph Schnelle
Address
University of Queensland
Herston Road
Herston QLD 4007
Country
Australia
Secondary sponsor category [1] 295682 0
None
Name [1] 295682 0
None
Address [1] 295682 0
N/A
Country [1] 295682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297943 0
School of Public Health Research Ethics Committee
Ethics committee address [1] 297943 0
Ethics committee country [1] 297943 0
Australia
Date submitted for ethics approval [1] 297943 0
Approval date [1] 297943 0
23/06/2015
Ethics approval number [1] 297943 0
CS23062015

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

Contacts
Principal investigator
Name 75538 0
Mr Christoph Schnelle
Address 75538 0
School of Public Health, Faculty of Medicine
University of Queensland
Herston Road
Herston QLD 4007
Country 75538 0
Australia
Phone 75538 0
+61266244242
Fax 75538 0
Email 75538 0
[email protected]
Contact person for public queries
Name 75539 0
Christoph Schnelle
Address 75539 0
School of Public Health, Faculty of Medicine
University of Queensland
Herston Road
Herston QLD 4007
Country 75539 0
Australia
Phone 75539 0
+61266244242
Fax 75539 0
Email 75539 0
[email protected]
Contact person for scientific queries
Name 75540 0
Christoph Schnelle
Address 75540 0
School of Public Health, Faculty of Medicine
University of Queensland
Herston Road
Herston QLD 4007
Country 75540 0
Australia
Phone 75540 0
+61266244242
Fax 75540 0
Email 75540 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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