Topic: Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England
Conditions
Interventions
Pilot study (9 months, n = 16):
The pilot will take place at two locations: Leeds and Warwick and will be delivered by two specially trained health visitors. The aim will be for each health visitor to
perceptions about the acceptability of the intervention, its content, its usefulness and the quality of the resources
and the outcome measures. This data will be used to modify and enhance the programme. Process data will also be collected regarding recruitment, number of sessions received by each participant etc. Th
Sponsors
Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a pre-pregnancy body mass index (BMI) of greater than or equal to 35 kg/m^2 2. Aged 16 years or over 3. Able to understand and communicate in English 4. Live within the Primary Care Trusts (PCT) area recruiting for the study (namely Leeds PCT and Heart of Birmingham PCT)
Exclusion criteria
Exclusion criteria: 1. Obesity has a medical cause 2. Develop pre-eclampsia or gestational diabetes during their pregnancy 3. Baby is born with any birth defects 4. Infant is on the child protection register 5. The woman has learning difficulties and is unable to fully understand the requirements of the study, or the woman's comprehension of English is insufficient to enable her to fully understand the study requirements
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Infant outcomes: 1. Infant weight gain on scales 2. Infant diet: diet and eating behaviour questionnaire 3. Eating pattern Parental outcomes: 1. Maternal weight and body mass index (BMI) 2. Maternal and family diet: food frequency questionnaire Data collection periods are at baseline (when the infant is 4 - 6 weeks old), when the infant is 9 months old, and again at 18 months of age. The secondary outcomes will be analysed against baseline at the two timepoints mentioned above. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate and acceptability of randomisation 2. Acceptability of the trial methodology Data collection periods are at baseline (when the infant is 4 - 6 weeks old), when the infant is 9 months old, and again at 18 months of age. The primary outcomes will be assessed quantitatively at recruitment as well as qualitatively at the end of the trial. | — |
Countries
United Kingdom
Outcome results
None listed