Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000912785
Ethics application status
Approved
Date submitted
29/07/2013
Date registered
15/08/2013
Date last updated
15/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile 'App' to Improve Iron and Zinc Intake, Iron and Zinc Status, Cognition, Mood and Fatigue in Premenopausal Women
Scientific title
Improving iron and zinc intake in premenopausal women through either dietary intake or supplements using mobile phone applications and measuring changes in cognition, mood and fatigue compared with control group
Secondary ID [1] 282887 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
WIZE study: Women's Iron, Zinc and Energy study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low iron status, fatigue, poor cognitive performance 289704 0
Condition category
Condition code
Diet and Nutrition 290029 290029 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in a 16-week three-arm randomised controlled trial (RCT). Apart from a healthy eating control group, there are two arms involving intervention, including the dietary group and the supplement group. All the participants in the RCT will have different mobile phone app(s) installed in their phones, according to which group they are randomly allocated to.

Participants in the intervention group will receive a mobile phone app with an online component that contains fact sheets and quizzes about dietary iron and zinc, and encourages dietary habits that may maximise iron and zinc absorption through a goal system. The goal system encourages participants to 1) eat two iron-fortified products each day, 2) eat 50 mg of vitamin C with meals, 3) use a point system where foods are assigned points depending on iron content, consume at least 12 points per day, and 4) drink coffee/tea away from meals.

Participants in the supplement group will be provided a supplement of 65.7 mg elemental iron daily for the duration for the 16 weeks of the study. The supplement will be taken orally as a film coated tablet. The participants will receive regular reminders of iron supplement intake and dietary advice for a "healthy diet" through mobile phone apps. There will be two apps involved for the supplement group. One app has an online component and contains fact sheets, reminder and a goal system encouraging participants to: 1) limit intake of saturated fat, 2) choose wholegrain foods, 3) reduce sodium intake, and 4) aim to eat 2 serves of fruit and 5 serves of vegetables daily. The second app is the publically available FoodSwitch app developed by Bupa and the George Institute which participants are encouraged to use when shopping for food.
Intervention code [1] 287592 0
Early detection / Screening
Intervention code [2] 287593 0
Lifestyle
Intervention code [3] 287595 0
Other interventions
Comparator / control treatment
Participants in the control group will receive dietary advice for a "healthy diet" through mobile phone applications, which are the same ones used in the supplement group without the supplement intake reminders.

Participants in all study arms will be asked not to consume supplements other than those provided in the study for the participants in the supplement group.
Control group
Active

Outcomes
Primary outcome [1] 290081 0
Changes in iron status (as assessed by changes in serum ferritin, haemoglobin and serum transferrin receptor).
Measurements of iron status will be serum ferritin, haemoglobin, and serum transferrin receptor and will be conducted by a local pathology laboratory (Dorevitch Pathology).
Timepoint [1] 290081 0
Baseline (week 0), week 12 and week 16
Primary outcome [2] 290228 0
Changes in zinc status (as assessed by serum zinc) in response to dietary change. Serum zinc concentrations will be determined by Professor Rosalind Gibson’s laboratory, University of Otago; samples will be collected as the same samples for iron status analysis, and will be processed, stored and analysed in accordance with the IZiNCG procedures.
Timepoint [2] 290228 0
Baseline (week 0), week 12 and week 16.
Secondary outcome [1] 303908 0
Changes in measures of cognition in both/either the intervention groups. Cognition will be measured using Wechsler Test of Adult Reading (WTAR), Verbal Memory and Learning California Verbal Learning Test (CVLT), and CogState, a computer-based cognitive assessment system consisting a battery of cognitive tests.
Timepoint [1] 303908 0
Baseline (week 0), week 12 and week 16
Secondary outcome [2] 304158 0
Changes in mood (depression and anxiety) in both/either the intervention groups. Mood will be measured by using Depression Anxiety Stress Scale (DASS).
Timepoint [2] 304158 0
Baseline (week 0), week 12 and week 16
Secondary outcome [3] 304159 0
Changes in fatigue (fatigue severity and impact, sleep quality) in both/either the intervention groups. Fatigue severity and impact will be determined using The Fatigue Severity Scale and the Daily Fatigue Impact Scale, respectively. Sleep quality will be determined using the Pittsburgh Sleep Quality Index.
Timepoint [3] 304159 0
Baseline (week 0), week 12 and week 16

Eligibility
Key inclusion criteria
Premenopausal women with serum ferritin less than 20 micrograms/L and haemoglobin equal to or greater than 120 g/L
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Post-menopausal
Currently pregnant or breastfeeding or have been in the past 12 months
Currently a blood donor or have donated blood in the past 12 months
Does not own a smartphone (iPhone or Android)
Haemoglobin less than 120 g/L
Serum ferritin equal to or greater than 20 micrograms/L

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be advertised publically using flyers and advertisements in newspapers/social network societies, community centres, health centres and Victorian schools, advertisements will either be included in school newsletters or a brief talk will be given at the school assembly to advertise the study and recruit younger participants from schools.
A fasting blood test will be used to determine whether participants have serum ferritin less than 20 micrograms/L and haemoglobin equal to or greater than 120 g/L.
Participants will be randomised to the control or intervention groups. Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer software MINIM will be used to randomise allocation and to stratify allocation according to vegetarian status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary endpoint of the RCT is the change in the natural logarithm of serum ferritin (micrograms/L) over the duration of the 16-week intervention period. A logarithmic transformation of the serum ferritin measurements is required to uncouple the variance-mean relationship in these measurements; variance-mean relationships are evident in the reports of Bruner and Joffe (Lancet, 348(9033): 992-; 1996), Heath et al (Journal of the American College of Nutrition, 20(5): 477-484; 2001) and Patterson et al (Journal of the American College of Nutrition, 20(4): 337-342; 2001). According to the listed studies, combined with statistical analysis on the between-subject variance, predictive power, a sample size of 91 participants is suggested. Thus the target sample size is set as 95.
The statistical package SPSS version 17.0 will be used for all data analysis.
The mean, SD and range of iron and zinc will be calculated for the participants as a whole and across age groups. The dietary record and food frequency questionnaire will be used to determine bioavailable iron and zinc intake from the different food groups and any inhibitors that affect absorption.
Cognitive results will also be analysed using the mean, SD and range from the participants as a whole and across age groups.
Regression analysis will be utilised to examine whether there is a significant relationship between iron and zinc intake and in blood samples, and whether improvements in iron and zinc status positively affects mood, levels of fatigue and concentration.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287673 0
Commercial sector/Industry
Name [1] 287673 0
Meat & Livestock Australia Ltd.
Country [1] 287673 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Meat & Livestock Australia Ltd.
Address
Level 1, 165 Walker Street, North Sydney NSW 2060
Postal address: Locked Bag 991, North Sydney NSW 2059
Country
Australia
Secondary sponsor category [1] 286409 0
University
Name [1] 286409 0
Deakin University
Address [1] 286409 0
221 Burwood Highway, Burwood VIC 3125
Country [1] 286409 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289636 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289636 0
Human Research Ethics Office, Deakin Research Integrity, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Ethics committee country [1] 289636 0
Australia
Date submitted for ethics approval [1] 289636 0
17/06/2013
Approval date [1] 289636 0
22/07/2013
Ethics approval number [1] 289636 0
2013-138

Summary
Brief summary
Premenopausal women are at increased risk of iron deficiency due to iron losses in menstrual blood and increased requirements during pregnancy. Additionally, inadequate consumption of dietary iron or over-consumption of compounds that impede absorption of iron (e.g. phytate) can result in iron requirements not being met. In addition, women who have a low dietary intake of iron and a low iron level are frequently at risk of a low intake of zinc. Rich dietary sources of iron also tend to be rich sources of zinc. Currently very little is known about the zinc status of Australian women.

The aim of this study is to investigate the use of technology to improve iron status, by determining if the dietary advice delivered by the mobile apps can 1) increases intake of bioavailable iron and zinc compared to a control "healthy diet" group; and 2) results in a significant improvement in iron and zinc status and markers of cognition, mood and fatigue compared with a control "healthy diet" group.

We hypothesise that:
The use of a mobile phone app to optimise intakes of bioavailable iron and zinc over a 16-week period in premenopausal women with low serum ferritin will result in:
a) higher dietary intake of bioavailable iron and zinc;
b) a greater improvement in iron status;
c) a greater improvement in cognition, mood (including indicators of depression and anxiety), fatigue and sleep compared to a control "healthy diet" group.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 41670 0
A/Prof Lynn Riddell
Address 41670 0
The School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 41670 0
Australia
Phone 41670 0
+61 3 9251 7270
Fax 41670 0
Email 41670 0
lynn.riddell@deakin.edu.au
Contact person for public queries
Name 41671 0
Feifei Hu
Address 41671 0
The School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 41671 0
Australia
Phone 41671 0
+61 3 9244 6324
Fax 41671 0
Email 41671 0
feifeih@deakin.edu.au
Contact person for scientific queries
Name 41672 0
Feifei Hu
Address 41672 0
The School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 41672 0
Australia
Phone 41672 0
+61 3 9244 6324
Fax 41672 0
Email 41672 0
feifeih@deakin.edu.au

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

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