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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
A physical activity feasibility randomised control trial for pregnant, obese women.
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
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group received usual care plus a blinded Fitbit pedometer.
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
a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group
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
Compliance
Compliance to the study procedures will be calculated by simple descriptive. statistics
Time frame: 5 weeks
Attrition
Drop out rate will be calculated by simple descriptive statistics.
Time frame: 5 weeks
Adherence rates
Adherence to Fitbit will be measured daily.
Time frame: 5 weeks
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
gestational diabetes status
Outcome of the gestational diabetes mellitus test at 26 weeks gestation.
Time frame: 26 weeks
Pregnancy and Birth outcomes
Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).
Time frame: 9 months
C-section
Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)
Time frame: 9 months
Birth weight
Weight of the baby at birth. This data will be collected from clinical notes.
Time frame: At delivery ( 9 months roughly)
Apgar score
5 minute Apgar Score. Score data will be collected from clinical notes.
Time frame: At delivery ( 9 months roughly)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheffield Hallam University