Clinical trial NCT03307733: Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women
Official title: Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Obesity Complicating Pregnancy
Maternal Obesity Complicating Childbirth
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility Randomized Control Trial
Primary purpose: PREVENTION

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* High risk of miscarriage

Primary outcomes:
measure: Recruitment
timeFrame: 5 weeks
measure: Compliance
timeFrame: 5 weeks
measure: Attrition
timeFrame: 5 weeks
measure: Adherence rates
timeFrame: 5 weeks
Secondary outcomes:
measure: Gestational Weight Gain
timeFrame: 5 weeks
measure: gestational diabetes status
timeFrame: 26 weeks
measure: Pregnancy and Birth outcomes
timeFrame: 9 months
measure: C-section
timeFrame: 9 months
measure: Birth weight
timeFrame: At delivery ( 9 months roughly)
measure: Apgar score
timeFrame: At delivery ( 9 months roughly)
Other outcomes:
Locations:
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