Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women (WiP)
Primary Purpose
Maternal Obesity Complicating Pregnancy, Maternal Obesity Complicating Childbirth
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
walking and behavour change techniques
Sponsored by
About this trial
This is an interventional prevention trial for Maternal Obesity Complicating Pregnancy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Intervention
Arm Description
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
Outcomes
Primary Outcome Measures
Recruitment
Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)
Compliance
Compliance to the study procedures will be calculated by simple descriptive. statistics
Attrition
Drop out rate will be calculated by simple descriptive statistics.
Adherence rates
Adherence to Fitbit will be measured daily.
Secondary Outcome Measures
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.
gestational diabetes status
Outcome of the gestational diabetes mellitus test at 26 weeks gestation.
Pregnancy and Birth outcomes
Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).
C-section
Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)
Birth weight
Weight of the baby at birth. This data will be collected from clinical notes.
Apgar score
5 minute Apgar Score. Score data will be collected from clinical notes.
Full Information
NCT ID
NCT03307733
First Posted
August 23, 2017
Last Updated
October 6, 2017
Sponsor
Sheffield Hallam University
1. Study Identification
Unique Protocol Identification Number
NCT03307733
Brief Title
Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women
Acronym
WiP
Official Title
Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Hallam University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Obesity Complicating Pregnancy, Maternal Obesity Complicating Childbirth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility Randomized Control Trial
Masking
None (Open Label)
Masking Description
It is difficult to mask in these type of interventions.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group received usual care plus a blinded Fitbit pedometer.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Intervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group
Intervention Type
Behavioral
Intervention Name(s)
walking and behavour change techniques
Intervention Description
a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group
Primary Outcome Measure Information:
Title
Recruitment
Description
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
Title
Compliance
Description
Compliance to the study procedures will be calculated by simple descriptive. statistics
Time Frame
5 weeks
Title
Attrition
Description
Drop out rate will be calculated by simple descriptive statistics.
Time Frame
5 weeks
Title
Adherence rates
Description
Adherence to Fitbit will be measured daily.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Gestational Weight Gain
Description
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
Title
gestational diabetes status
Description
Outcome of the gestational diabetes mellitus test at 26 weeks gestation.
Time Frame
26 weeks
Title
Pregnancy and Birth outcomes
Description
Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).
Time Frame
9 months
Title
C-section
Description
Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)
Time Frame
9 months
Title
Birth weight
Description
Weight of the baby at birth. This data will be collected from clinical notes.
Time Frame
At delivery ( 9 months roughly)
Title
Apgar score
Description
5 minute Apgar Score. Score data will be collected from clinical notes.
Time Frame
At delivery ( 9 months roughly)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women can be pregnant
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women
We'll reach out to this number within 24 hrs