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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]

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

Obesity

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Diet and Nutrition

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]

Behaviour

Intervention code [2]

Prevention

Intervention code [3]

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]

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]

At study conclusion

Secondary outcome [1]

Daily step count

Timepoint [1]

At study conclusion

Secondary outcome [2]

Daily minutes at each activity level

Timepoint [2]

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

Sex

Females

Can healthy volunteers participate?

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

6/02/2017

Actual

6/03/2017

Date of last participant enrolment

Anticipated

2/10/2017

Actual

15/05/2017

Date of last data collection

Anticipated

2/10/2017

Actual

1/12/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Sunshine Hospital - St Albans

Recruitment postcode(s) [1]

3021 - St Albans

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia and Pain Medicine, Sunshine Hospital

Address [1]

Department of Anaesthesia and Pain Medicine
Sunshine Hospital
Furlong Road
St Albans VIC 3021

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

Office for Research
The Royal Melbourne Hospital Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australi

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/09/2016

Approval date [1]

20/12/2016

Ethics approval number [1]

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

Dr Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 3 9342 7136

Fax

jai.darvall@mh.org.au

Contact person for public queries

Name

Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 3 9342 7136

Fax

jai.darvall@mh.org.au

Contact person for scientific queries

Name

Jai Darvall

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 3 9342 7136

Fax

jai.darvall@mh.org.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Pedometer-Guided Physical Activity Intervention for Obese Pregnant Women (the Fit MUM Study): Randomized Feasibility Study.	2020	https://dx.doi.org/10.2196/15112

N.B. These documents automatically identified may not have been verified by the study sponsor.

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