Physical activity in women with gestational diabetes mellitus (GDM) Nutritional, Metabolic, Endocrine
Conditions
Interventions
Following their hospital clinic appointment, a research midwife will talk them through the study procedure and give them the chance to ask any questions. If they consent to take part in the study, the
Sponsors
Oxford University Hospitals NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/08/2022: 1. Women who are more than 20 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy 2. Abnormal Oral Glucose Tolerance Test (OGTT) as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic. 3. Using GDm-Health to monitor their blood glucose 4. Aged between 18 and 45 years 5. Willing and able to provide informed consent for participation in the study 6. Have, and use, a smartphone Previous inclusion criteria: 1. Women who are more than 24 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy 2. Abnormal Oral Glucose Tolerance Test (OGTT) as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic. 3. Using GDm-Health to monitor their blood glucose 4. Aged between 18 and 45 years 5. Willing and able to provide informed consent for participation in the study 6. Have, and use, a smartphone
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancy 2. GDM not diagnosed by OGTT, HbA1C or fasting plasma glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID 19) pandemic 3. An absolute contra-indication to physical activity as per 2019 Canadian guidelines (Mottola M et al, 2018) e.g. preterm rupture of membranes, limited mobility, haemodynamically significant heart disease, restrictive lung disease 4 Unable to understand written or spoken English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/08/2022: The feasibility and acceptability of the intervention to inform a decision on whether a randomised controlled trial is warranted: 1. Recruitment rates measured as a percentage of women with GDM who are eligible for the study at first contact with potential recruit: 1.1. The percentage of eligible participants at the Gestational Diabetes Clinic, Women Centre, John Radcliffe Hospital 1.2. The percentage of women who fulfil the eligibility criteria and accept the invitation to participate 2. Retention rate measured by assessing the proportion of women that completed the study at visit 3 - 36 week gestation (number) 3. Participant engagement with the intervention measured using: 3.1. Participant adherence rates to wrist-worn accelerometer at baseline visit and at baseline and visit 3 between 36 and 38 weeks pregnant (number of days worn over 7 days period, average daily wear, portion of wear (hours); availability of data for Physical Activity (PA) outcome measures) 3.2. Attendance rate at follow-up sessions 3.3. Completion rates of self-reported PA questionnaires (both at baseline and follow-up visit 3) 3.4. Proportion of participants who set goals on Stay-Active (%) during the study period 3.5. Proportion of participants who recorded PA on Stay-Active (%) during the study period 4. Acceptability of the interview with Completion of the Oxford Maternity Diabetes Treatment Satisfaction Questionnaire (OMDTSQ) by participants at baseline and between 36 and 38 weeks pregnant. 5. Fidelity of the motivational interviewing component of the intervention measured in 10% of participants' MI interviews one week after study enrolment 5.1. Whether all Motivational Interviews are audio recorded 5.2. 10% of motivational interviews will be coded using the Motivational Interviewing Treatment Integrity Code (MITI 4.2.1) to assess the fidelity of sessions Previous primary outcome measures: 1. Participant adherence measured by hours of w | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/08/2022: 1. Physical activity (PA) levels assessed using information on physical activity time, type, intensity, and frequency assessed from baseline and follow-up visits: 1.1. Device-specific (accelerometer) data: Total PA average per measured day in moderate to vigorous (defined as any movement with a measured acceleration value =93.2 mg). PA and average accelerations in g (the standard SI unit of acceleration) 1.2. Pregnancy Physical Activity Questionnaire (PPAQ) – outcome: Energy expenditure (units measure of average weekly energy expenditure (MET-h·week-1) in both moderate (activities >3.0 and 6.0 METs) 1.3. Exercise Vital Sign – total weekly minutes of Moderate to Vigorous PA 2. Usage and participant attitudes to +Stay Active: 2.1. Stay-Active usage during the study period from enrolment and activation of the App to completion: 2.1.1. Average time spent on app per week (seconds and minutes) 2.1.2. Average time per session (seconds and minutes) 2.1.3. Frequency of app opened and duration per session (seconds) 2.1.4. Number of participants logging activity per week 2.2. Participants' attitudes to +Stay-Active (5 questions rating) on the usefulness of motivational interviewing, goal setting, tracking your goals via the app, automated motivational messages, personalised messages and an open comments section at approximately 36 weeks pregnant 3. Blood glucose control and medication prescribed assessed using: 3.1. Difference in glycaemic control measured as mean blood glucose (mmol/L) at recruitment and at 36-38 weeks (using blood glucose taken in the week that the accelerometer is worn), adjusted for number and timing of measurements 3.2. Participant’s prescribed medication (generic name and dose) from enrolment to end of the study 4. Maternal and neonatal outcomes measured using collected from medical records within 6 weeks after birth 4.1. Maternal outcomes (weight gain (kg), pharmacological medication (initiation, | — |
Countries
England, United Kingdom
Outcome results
None listed