Empowering Parents to Prevent Obesity at Weaning
- Conditions
- Topic: Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for EnglandSubtopic: Not Assigned, Generic Health Relevance (all Subtopics)Disease: All Diseases, Public Health ResearchNutritional, Metabolic, EndocrineObesity
- Registration Number
- ISRCTN05847845
- Lead Sponsor
- Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 64
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Recruitment rate and acceptability of randomisation<br>2. Acceptability of the trial methodology<br><br>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.
- Secondary Outcome Measures
Name Time Method Infant outcomes:<br>1. Infant weight gain on scales<br>2. Infant diet: diet and eating behaviour questionnaire<br>3. Eating pattern<br><br>Parental outcomes:<br>1. Maternal weight and body mass index (BMI)<br>2. Maternal and family diet: food frequency questionnaire<br><br>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.