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.
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
- Conditions the study is for
- Maternal Obesity Complicating Pregnancy, Maternal Obesity Complicating Childbirth
- What is being tested?
- walking and behavour change techniques
- Type of treatment
- Lifestyle or therapy programme
- 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 group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group received usual care plus a blinded Fitbit pedometer. |
| Intervention | Active comparator | Intervention 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.
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
Compliance
Compliance to the study procedures will be calculated by simple descriptive. statistics
Measured: 5 weeks
Attrition
Drop out rate will be calculated by simple descriptive statistics.
Measured: 5 weeks
Adherence rates
Adherence to Fitbit will be measured daily.
Measured: 5 weeks
Secondary outcomes (6)
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
gestational diabetes status
Outcome of the gestational diabetes mellitus test at 26 weeks gestation.
Measured: 26 weeks
Pregnancy and Birth outcomes
Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).
Measured: 9 months
C-section
Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)
Measured: 9 months
Birth weight
Weight of the baby at birth. This data will be collected from clinical notes.
Measured: At delivery ( 9 months roughly)
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.
- First posted12 Oct 2017
- Study start1 Sep 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Obesity Complicating PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women
- ClinicalTrials.gov ID
- NCT03307733
- Acronym / sponsor ID
- WiP / STH19365
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A physical activity feasibility randomised control trial for pregnant, obese women.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group received usual care plus a blinded Fitbit pedometer. |
| Intervention | Active comparator | Behavioral: walking and behavour change techniquesIntervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant 11-14 weeks gestation
- BMI >30kg/m2
- No known risks or complications
- Able to walk
Key exclusion criteria (1 listed)
- High risk of miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking and behavour change techniquesa Fitbit pedometer with individualised step targets and partaking in a closed Facebook group | Behavioural | Intervention |
Primary outcome
Recruitment
Time frame: 5 weeks
Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)
Compliance
Time frame: 5 weeks
Compliance to the study procedures will be calculated by simple descriptive. statistics
Attrition
Time frame: 5 weeks
Drop out rate will be calculated by simple descriptive statistics.
Adherence rates
Time frame: 5 weeks
Adherence to Fitbit will be measured daily.
6 secondary outcomes
Gestational Weight Gain
Time frame: 5 weeks
gestational diabetes status
Time frame: 26 weeks
Pregnancy and Birth outcomes
Time frame: 9 months
C-section
Time frame: 9 months
Birth weight
Time frame: At delivery ( 9 months roughly)
Apgar score
Time frame: At delivery ( 9 months roughly)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.