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

A physical activity feasibility randomised control trial for pregnant, obese women.

Study Overview

• Status: Completed
• Conditions: Maternal Obesity Complicating Pregnancy; Maternal Obesity Complicating Childbirth
• Intervention / Treatment: Behavioral: walking and behavour change techniques

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• High risk of miscarriage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Control group received usual care plus a blinded Fitbit pedometer.
Active Comparator: Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)	5 weeks
Compliance	Compliance to the study procedures will be calculated by simple descriptive. statistics	5 weeks
Attrition	Drop out rate will be calculated by simple descriptive statistics.	5 weeks
Adherence rates	Adherence to Fitbit will be measured daily.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 weeks
gestational diabetes status	Outcome of the gestational diabetes mellitus test at 26 weeks gestation.	26 weeks
Pregnancy and Birth outcomes	Preeclampsia ( Percentage figure of patients who developed preeclampsia during birth will be calculated from clinical notes).	9 months
C-section	Mode of Delivery ( Number of participants from each group who have a C-section will be calculated)	9 months
Birth weight	Weight of the baby at birth. This data will be collected from clinical notes.	At delivery ( 9 months roughly)
Apgar score	5 minute Apgar Score. Score data will be collected from clinical notes.	At delivery ( 9 months roughly)

Collaborators and Investigators

• Sponsor: Sheffield Hallam University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pregnancy Complications; Obesity, Maternal
• Other Study ID Numbers: STH19365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No