Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine
Conditions
Interventions
Clusters (NHS Trusts providing maternity services) will be randomly allocated to intervention or control arms, stratified by size of cluster, using computer randomisation methods. Participants are com
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Midwives: 1. Midwives who have provided written informed consent for participation in the study prior to any study specific procedures 2. Community midwife role 3. Hospital-based midwife with a specific maternal obesity or weight management role Pregnant women: 1. Pregnant women who have provided written informed consent for participation in the study prior to any study specific procedures 2. Booking body mass index =30kg/m2 (proxy measure for pre-pregnancy BMI) 3. Age at least 18 years (teenage pregnancies require specific nutritional support) 4. Singleton pregnancies (multiple pregnancies require specific nutritional support) 5. Women who have had their 12 week ultrasound scan and their pregnancy has progressed beyond the high risk period for miscarriage
Exclusion criteria
Exclusion criteria: Midwives: 1. Hospital-based midwives without a specific maternal obesity or weight management role 2. Non-midwifery health professionals 3. Inability to speak/read English Pregnant women 1. Pregnant women with a medical condition other than obesity which requires them to receive specialist weight management advice for that condition (e.g. women with pre-gestational diabetes who are attending a specialist antenatal diabetes clinic, pregnant women who have had bariatric surgery (e.g. gastric band or bypass) and require specialist nutritional support) 2. Pregnant women with substance misuse or known cause for concern (e.g. domestic violence) 3. Inability to speak/read English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate of midwives attending the intervention training day in the intervention arm, calculated as percentage of eligible midwives consenting and attending the intervention (training) session 2. Feasibility of intervention delivery, calculated as the number of intervention sessions delivered with the planned number of midwives in attendance at each session (planned 6 midwives per session) 3. Intensity of intervention delivery, calculated as the number of intervention sessions required to deliver the intervention to all recruited midwives in the intervention arm at the end of intervention delivery 4. Time required for intervention delivery, calculated for all intervention sites as the number of weeks from the first contact with the site to arrange the delivery of the intervention, and the delivery of the final intervention session 5. Fidelity of intervention delivery, calculated as the frequency of the delivery of the intervention as planned measured by direct observation and video recording of the intervention sessions, and frequency of deviation from protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Process evaluation of the content, resources and delivery of the intervention, to be measured by: 1.1. Direct observations and video recordings of the intervention delivery for all intervention sessions 1.2. Participant evaluation forms to completed by midwives attending the intervention on the day of the intervention 1.3. Focus groups with a sample of midwives who have received the intervention, 1 month after intervention delivery 2. Process evaluation of the implementation of guidelines into routine midwifery practice following the intervention, to be measured by: 2.1. Midwife social cognitive theory questionnaires at baseline (pre-intervention) and 3 and 6 months after intervention delivery 2.2. Focus groups with a sample of midwives who have received the intervention, 1 month after intervention delivery 3. Process evaluation of women’s experience of midwifery care relating to their weight and implementation of midwifery advice and support into their own behaviours, among women with obesity (BMI=30kg/m2) receiving care from midwives in the intervention arm, to be measured by: 3.1. A range of questionnaires in one pack for women to measure the advice received from their midwife about their weight and weight management, food frequency questionnaire, physical activity in pregnancy questionnaire, feelings about their weight, relationship with their midwife, and quality of life at baseline (3rd trimester) 3.2. Semi-structured interviews in the third trimester and at 6 months postnatal 4. Data required for sample size estimations for a future definitive trial will be measured by: 4.1. Calculating variance of the intervention primary and secondary outcome measures (data collection by questionnaires) for the midwives at baseline (pre-intervention) and follow up (3 and 6 months after intervention delivery) 4.2. Calculating variance of the intervention primary (weight measurement) and secondary (questionnaire) outcome measures for the pregnant women at baseline (3rd | — |
Countries
England, United Kingdom
Contacts
Public ContactNicola Heslehurst
Outcome results
None listed