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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
Sheffield Hallam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Obesity Complicating Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    August 23, 2017
    Last Updated
    October 6, 2017
    Sponsor
    Sheffield Hallam University
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    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

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

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