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Trial registered on ANZCTR


Registration number
ACTRN12617000038392
Ethics application status
Approved
Date submitted
23/12/2016
Date registered
10/01/2017
Date last updated
16/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a pedometer guided physical activity intervention in limiting weight gain in pregnant obese women (The Fit MUM feasibility study)
Scientific title
Feasibility of a pedometer guided physical activity intervention in limiting weight gain in pregnant obese women (The Fit MUM feasibility study)
Secondary ID [1] 290805 0
Nil known
Universal Trial Number (UTN)
U1111-1184-1167
Trial acronym
The Fit MUM feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
Antenatal care
301456 0
Obesity 301457 0
Condition category
Condition code
Reproductive Health and Childbirth 301231 301231 0 0
Antenatal care
Diet and Nutrition 301232 301232 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty obese pregnant women (body mass index greater than or equal to 30 kg/m2 at first clinic booking ) aged 18 years or over, will be supplied with the Fitbit Zip (registered trademark) pedometer and wear it on a daily basis during waking hours until final antenatal visit. Women will be randomised into three groups of 10:
1. Control Group: will wear the pedometer, blinded to daily step counts.
2. Intervention Group A, Pedometer feedback only: will have pedometer “synched” to their personal smartphone, with ability to self-monitor daily step counts.
3. Intervention Group B, Pedometer feedback + behavior change: will have an added behavior change program in addition to pedometer feedback, with additional regular support from study investigators.
Participants in groups 2 and 3 will be encouraged to increase their physical activity levels in line with the Australian Physical Activity guidelines for adults, aiming for at least 30 minutes of moderate physical activity most days of the week (or 150 minutes per week). The Fitbit pedometer registers this level of physical activity as “fairly” or “very” active and equates to approximately 10,000 steps per day.

Intervention Group B: In addition to written resources and synching of pedometer data, patients will receive an intervention involving a face-to-face session with a health coach, with follow up telephone and monthly mobile phone text messages (SMS) throughout the intervention until delivery, to remind participants to practice the new behaviours, as used in previous trials. This is based on the successful “HeLP-her” intervention. This intervention is based on self-determination and cognitive behavioural theory, with motivational interviewing the primary method of interaction with participants. The aim will be to support and empower pregnant women to optimise their weight gain during pregnancy. The sessions will progressively educate women about the importance of healthy eating and physical activity during pregnancy, the balance between energy intake and energy expenditure, removing common misconceptions about exercise in pregnancy, increasing confidence about exercise and optimising daily healthy food choices and physical activity throughout pregnancy. Intervention content is underpinned by key components of the behavioural theory including skills of goal setting, action planning and self-monitoring all of which are important factors in long-term behavioural change. The sessions will be interactive and involve practising skills in behaviour change in the form of action planning, removing barriers, identifying enablers, self-monitoring and social persuasion. They will be encouraged to weigh themselves regularly as self-monitoring has been shown through past trials to significantly limit gestational weight gain when coupled with lifestyle intervention. Participants will first attend a one-on-one initial 30 minute assessment session at baseline (16 weeks), followed by one facilitator-led interactive small group session of 60 minutes between 16 and 20 weeks gestation held in the antenatal clinic at Sunshine Hospital. The facilitator will be a trained health coach, trained in the HeLP-her intervention by the developers of the tool at Monash University. Using the topics presented in Session 1 as a guide, participants will be assisted by the facilitator to generate goals and action plans based on their personal priorities, thereby developing a personalised gestational weight gain strategy. At gestational weeks 20 and 24 they will receive a 20 minute telephone coaching session delivered by staff trained in motivational interviewing, which utilise client-orientated counselling to explore and resolve ambivalence and review progress, provide encouragement and assistance and to ensure skills are practiced and action plans are completed. By 28 weeks of pregnancy, participants will have received one face-to-face interactive session, one group intervention and 2 telephone coaching sessions.
Intervention code [1] 296727 0
Behaviour
Intervention code [2] 296728 0
Prevention
Intervention code [3] 296766 0
Treatment: Devices
Comparator / control treatment
Masked pedometers will be supplied to the control group to record baseline steps, with written resources provided including the Australian Physical Activity and Sedentary Behaviour Guidelines, the guidelines on pregnancy and exercise published by Physical Activity Australia, and dietary guidelines for Australian Adults. Brief general physical activity advice framed around these guidelines will be provided at baseline.
Control group
Active

Outcomes
Primary outcome [1] 300596 0
Specific (composite) feasibility outcomes
1. Willingness of participants to be recruited (recruitment rate)
2. Maintenance of blinding of control group to pedometer step count (concealment of pedometer display with tamper proof tape)
3. Patient compliance with wearing pedometers, and synching data regularly
4. Patient follow up to study conclusion, with minimal dropout rate
5. Target population recruitment feasibility (number of potential participants attending antenatal clinic)
6. Data integrity and completeness of uploaded step counts to investigators
7. Estimate of standard deviation of main outcome measures (excessive gestational weight gain, step count) to further inform definitive trial sample size
Timepoint [1] 300596 0
At study conclusion
Secondary outcome [1] 330486 0
Daily step count
Timepoint [1] 330486 0
At study conclusion
Secondary outcome [2] 330487 0
Daily minutes at each activity level
Timepoint [2] 330487 0
At study conclusion

Eligibility
Key inclusion criteria
1. Pregnant woman aged 18 years or over
2. Body mass index greater than or equal to 30 kg/m2 at baseline (gestational week 12-15)
3. Recruitment below 20 weeks gestation
4. No mobility impairment (ie. able to ambulate normally without gait aids)
5. Availability of a smartphone capable of allowing Fitbit data uploading (eg. Apple iPhone (registered trademark) or Android (registered trademark) operating system equipped phone).
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Joint or muscle disorder sufficient to impair walking to a target of 10,000 steps daily.
2. Pre-eclampsia diagnosis
3. Twin or multiple pregnancy
4. Preterm rupture of membranes
5. Incompetent cervix/cerclage

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)
Blinded envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised from a computer generated list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Continuous data (such as step count, minutes at each activity level) will be tested for normality. Normally distributed data will be summarised using mean and standard deviation and will be compared between the three groups using one-way analysis of variance. Non-normally distributed data will be summarised with median (range/IQR) and will be compared using the Kruskal-Wallis test. Categorical data will be summarised using number (count) and differences across groups assessed using Chi-squared tests. Potential confounders of the association between excessive weight gain, activity levels/step counts and group allocation will be explored using multivariate logistic regression. These potential confounding variables may include age, weight, height, parity, country of birth, household income and educational background, as these have been previously shown to influence activity levels in pregnancy

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7177 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 14938 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 295231 0
Hospital
Name [1] 295231 0
Department of Anaesthesia and Pain Medicine, Sunshine Hospital
Address [1] 295231 0
Department of Anaesthesia and Pain Medicine
Sunshine Hospital
Furlong Road
St Albans VIC 3021
Country [1] 295231 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Medicine, Sunshine Hospital
Address
Department of Anaesthesia and Pain Medicine
Sunshine Hospital
Furlong Road
St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 294059 0
None
Name [1] 294059 0
Address [1] 294059 0
Country [1] 294059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296572 0
Melbourne Health
Ethics committee address [1] 296572 0
Office for Research
The Royal Melbourne Hospital Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australi
Ethics committee country [1] 296572 0
Australia
Date submitted for ethics approval [1] 296572 0
26/09/2016
Approval date [1] 296572 0
20/12/2016
Ethics approval number [1] 296572 0
HREC/16/MH/320

Summary
Brief summary
The aim of this study is to determine the feasibility of implementing a pedometer intervention to reduce the incidence of excessive gestational weight gain in pregnant obese women in a cost effective, reliable manner. The results from this feasibility trial will help guide a future large, multicentre randomised trial. In detail, we aim to:

1. Refine and test the trial protocol for a follow-on large multicentre trial;
2. Examine efficacy in increasing activity level to a target of 150 minutes of “fairly active” or “very active” time per week in pregnant obese women via feedback from the Fitbit Zip (registered trademark) pedometer in line with Australian National Physical Activity Guidelines for adults;
3. Examine efficacy in increasing step count at least 150% from baseline measurements (up to 10,000 steps) via feedback from the Fitbit Zip (registered trademark) pedometer;
4. Evaluate the impact of investigator feedback compared with participant self-monitoring alone, on the reduction in excessive gestational weight gain of pregnant obese participants;
5. Confirm earlier trial results, in healthy volunteers, in assessing acceptability of the trial protocol and pedometer use to our patients and antenatal staff, as a high recruitment and participation rate will be required for a viable definitive study;
6. Determine retention rates over the trial period (as dropouts over participants’ pregnancies will significantly limit a future RCT);
7. Assess the magnitude of any effect of the interventions (with particular respect to reducing the incidence of excessive gestational weight gain, and increasing activity and step count levels) to further inform sample size calculation for a definitive trial.


Study Outline

Thirty obese pregnant women (body mass index greater than or equal to 30 kg/m2 at first clinic booking ) aged 18 years or over, will be supplied with the Fitbit Zip (registered trademark) pedometer and wear it on a daily basis during waking hours until final antenatal visit. Women will be randomised into three groups of 10:
1. Control Group: will wear the pedometer, blinded to daily step counts.
2. Intervention Group A, Pedometer feedback only: will have pedometer “synched” to their personal smartphone, with ability to self-monitor daily step counts.
3. Intervention Group B, Pedometer feedback + behavior change: will have an added behavior change program in addition to pedometer feedback, with additional regular support from study investigators.
Participants in groups 2 and 3 will be encouraged to increase their physical activity levels in line with the Australian Physical Activity guidelines for adults, aiming for at least 30 minutes of moderate physical activity most days of the week (or 150 minutes per week). The Fitbit pedometer registers this level of physical activity as “fairly” or “very” active and equates to approximately 10,000 steps per day.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66594 0
Dr Jai Darvall
Address 66594 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 66594 0
Australia
Phone 66594 0
+61 3 9342 7136
Fax 66594 0
Email 66594 0
jai.darvall@mh.org.au
Contact person for public queries
Name 66595 0
Dr Jai Darvall
Address 66595 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 66595 0
Australia
Phone 66595 0
+61 3 9342 7136
Fax 66595 0
Email 66595 0
jai.darvall@mh.org.au
Contact person for scientific queries
Name 66596 0
Dr Jai Darvall
Address 66596 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 66596 0
Australia
Phone 66596 0
+61 3 9342 7136
Fax 66596 0
Email 66596 0
jai.darvall@mh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary