ClinicalTrials.gg
CompletedNCT03307733WiPUpdated Oct 12, 2017

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

An interventional study of walking and behavour change techniques in Maternal Obesity Complicating Pregnancy and Maternal Obesity Complicating Childbirth, sponsored by Sheffield Hallam University. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-12.

Sponsored by Sheffield Hallam University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2016, registered Aug 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Maternal Obesity Complicating Pregnancy
  • Maternal Obesity Complicating Childbirth

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03

In context

Pregnancy in Obesity

60 studies on the registry are indexed under Pregnancy in Obesity; 17 are open to participants now.

This study's enrollment of 40 is below the median of 160 across 33 interventional studies indexed under Pregnancy in Obesity.

Browse Pregnancy in Obesity studies →

Lead sponsor

Sheffield Hallam University is the lead sponsor of 48 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • High risk of miscarriage
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    Control Group

    Control group received usual care plus a blinded Fitbit pedometer.

  • Active comparator
    Intervention

    Intervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group

    Behavioral: walking and behavour change techniques

Interventions

  • Behavioralwalking and behavour change techniques

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

06

What researchers measure

Primary outcomes

  1. Recruitment

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

    Time frame: 5 weeks

  2. Compliance

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

    Time frame: 5 weeks

  3. Attrition

    Drop out rate will be calculated by simple descriptive statistics.

    Time frame: 5 weeks

  4. Adherence rates

    Adherence to Fitbit will be measured daily.

    Time frame: 5 weeks

Secondary outcomes

  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.

    Time frame: 5 weeks

  2. gestational diabetes status

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

    Time frame: 26 weeks

  3. Pregnancy and Birth outcomes

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

    Time frame: 9 months

  4. C-section

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

    Time frame: 9 months

  5. Birth weight

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

    Time frame: At delivery ( 9 months roughly)

  6. Apgar score

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

    Time frame: At delivery ( 9 months roughly)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Jul 2017, 10 months.

Of 19 interventional studies with no phase under Pregnancy in Obesity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2017
First posted
Oct 12, 2017
StartActual
Sep 1, 2016
Primary completionActual
Jul 1, 2017
CompletionActual
Jul 1, 2017
Last update
Oct 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03307733
Lead sponsor
Sheffield Hallam University
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Sep 1, 2016
Primary completion
Jul 1, 2017
Completion
Jul 1, 2017
Last update
Oct 12, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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