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Maternal Obesity Complicating PregnancyWiPNCT03307733

Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women

A study testing walking and behavour change techniques in people with Maternal Obesity Complicating Pregnancy and Maternal Obesity Complicating Childbirth, run by Sheffield Hallam University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A physical activity feasibility randomised control trial for pregnant, obese women. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
walking and behavour change techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Sep 2016to 1 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • pregnant 11-14 weeks gestation
  • BMI >30kg/m2
  • No known risks or complications
  • Able to walk

Who cannot join

  • High risk of miscarriage

About this study

A physical activity feasibility randomised control trial for pregnant, obese women.

Read the detailed description

Overweight (defined as BMI ≥25kg/m2) and obesity (defined as BMI ≥30kg/m2) during pregnancy is becoming more common. Approximately 25-30% of women of childbearing age are obese and around 50% are overweight at the time of conception. Women who are either overweight or obese have a much higher risk of adverse pregnancy outcomes. For example, they are more likely to develop gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, Caesarean section and other complications. Recent research suggests that overweight and obese pregnant women are less active than normal weight ( BMI≤ 25kg/m2) pregnant women and also that the level of physical activity decreases throughout pregnancy. The evidence also suggests that maintaining a good level of physical activity can reduce the risks of adverse pregnancy outcomes. A large study which looked at the most preferred types of physical activity identified that walking and swimming were the most preferred types of physical activity by pregnant women. Although there is an association between walking at a brisk pace and a reduced risk of gestational diabetes, there is no definitive conclusion on the effectiveness of walking interventions. The investigators are proposing this feasibility study in order to find out whether a walking intervention can be implemented during pregnancy in the obese population to reduce adverse pregnancy health outcomes. The current study will investigate whether a Fitibit Pedometer and a Social networking Site (Facebook) can be used to encourage pregnant, obese women to increase and maintain activity during pregnancy. The feasibility study will test the recruitment strategy, acceptability of the intervention design, randomisation acceptability, and timing of the intervention. Participants from both the control and the intervention will be purposefully selected to take part in focus group following the intervention in order to give feedback on the study. The investigators will be working with an Obstetrics \& Gynaecology consultant at Jessop Wing, Hallamshire Hospital to help with the recruitment process and provide clinical advice. Women who are obese (BMI>30kg/m2) in their early pregnancy (12-14 weeks) will be recruited. Participants that consent to take part in the study will be given a Fitbit pedometer and enrolled in a closed Facebook group. Each participant will wear a Fitbit for a week in order to measure their baseline physical activity level. Thereafter, the participants in the intervention will be asked to gradually increase their physical activity level (they will be given a weekly step target)for 4 weeks in total. The Facebook component of the intervention will contain motivational and educational posts and rewarding messages about their progress. The control group will be asked to wear a Fitbit for 5 weeks and do their usual activities in total with a covered screen so as to not see the step count

Being tested
walking and behavour change techniques

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • walking and behavour change techniquesBehavioural

    a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group

Study groups in NCT03307733
Study groupRoleWhat they receive
Control GroupNo interventionControl group received usual care plus a blinded Fitbit pedometer.
InterventionActive comparatorIntervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group
Receives: Behavioral: walking and behavour change techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)

    Measured: 5 weeks

  2. Compliance

    Compliance to the study procedures will be calculated by simple descriptive. statistics

    Measured: 5 weeks

  3. Attrition

    Drop out rate will be calculated by simple descriptive statistics.

    Measured: 5 weeks

  4. Adherence rates

    Adherence to Fitbit will be measured daily.

    Measured: 5 weeks

Secondary outcomes (6)
  1. Gestational Weight Gain

    Women are recruited at 11-14 weeks gestation and after 5 weeks when they are at 20 weeks gestation the final assessments will be collected. Weight is measured in kilograms.

    Measured: 5 weeks

  2. gestational diabetes status

    Outcome of the gestational diabetes mellitus test at 26 weeks gestation.

    Measured: 26 weeks

  3. Pregnancy and Birth outcomes

    Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).

    Measured: 9 months

  4. C-section

    Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)

    Measured: 9 months

  5. Birth weight

    Weight of the baby at birth. This data will be collected from clinical notes.

    Measured: At delivery ( 9 months roughly)

  6. Apgar score

    5 minute Apgar Score. Score data will be collected from clinical notes.

    Measured: At delivery ( 9 months roughly)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start1 Sep 2016
  3. Primary completion1 Jul 2017
  4. Study completion1 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility Randomized Control Trial
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03307733
Sponsor's protocol ID
STH19365
Acronym
WiP
Status last verified
Oct 2017
First submitted
23 Aug 2017
Last updated
12 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing walking and behavour change techniques in people with Maternal Obesity Complicating Pregnancy and Maternal Obesity Complicating Childbirth, run by Sheffield Hallam University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.

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