Women who are overweight after having given birth Nutritional, Metabolic, Endocrine Public health
Conditions
Interventions
The PIMMS-WL trial is a randomised controlled cluster feasibility trial. First, a feasibility trial is run before undertaking a large-scale phase III RCT to assess the clinical and cost-effectiveness
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or more 2. Women who are at least 4 weeks postnatal and who have not yet attended the first child immunisation appointment 3. Planning to have their child immunised within the national immunisation programme 4. BMI 25 kg/m2 or more at the time of recruitment at the baseline home visit 5. Patient able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 24/01/2019: 1. Mothers whose babies have died or have been removed from their care at birth 2. Women who indicate they are already actively involved in a weight loss programme or weight management trial to lose weight 3. Unwilling to give consent to notify their GP 4. Women who have been diagnosed with a serious mental health difficulty requiring hospitalisation in the past two years or been diagnosed with anorexia and/or bulimia in the past two years Previous exclusion criteria: 1. Mothers whose babies have died or have been removed from their care at birth 2. Women who indicate they are already actively involved in a weight loss programme or weight management trial to lose weight 3. Unwilling to give consent to notify their GP 4. Women who are using illicit drugs, alcohol dependant, experiencing serious mental health difficulties (e.g. postnatal psychosis) or known history of eating disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 24/01/2019: 1. The feasibility of a full-scale phase III cluster RCT. This decision will be based on the acceptability of the trial using a composite assessment of both quantitative and qualitative data and will include assessment of the following: 1.1. Whether the trial is appealing to women (via assessment of the recruitment rate to ensure a full phase III trial is feasible) 1.2. Whether the intervention is acceptable 1.3. Whether the intervention has any adverse impact on infant immunisation rates 1.4. The number of women who complete the trial and complete the trial questionnaires 2. The recruitment rate will be presented as the proportion of eligible participants who took part in the trial (i.e. the number of participants who agreed to enrol in the trial divided by the number of eligible participants invited to take part in the trial). BWH will provide data on the number of invitation letters sent, along with data on age, ethnicity and IMD score of women who were sent an invitation. Data on age and ethnicity will be provided in summary format. The IMD score will be calculated on the postcode of the participant and will be provided for each participant invited. These data will be used to calculate the recruitment rate so a comparison of the socio-demographics of participants recruited and those who did not respond to the invitation can be made. 3. The quantitative assessment of whether the intervention is acceptable will be based on the adherence of women to weekly self-weighing. The trial includes three sources of data regarding frequency of self-weighing; objective recording scales, self-reported in the red book and recordings using the POWeR programme. The objective recording of weight on the scales will be the authoritative source of data for frequency of self-weighing/adherence. If this is not available, the red bo | — |
Secondary
| Measure | Time frame |
|---|---|
| While this feasibility trial will not be powered to detect meaningful differences in outcome measures, it will give us the opportunity to ensure that there are no issues with the completion of these measures in preparation for the main trial. 1. Demographic, lifestyle and pregnancy related information will be collected using the PIMMS-WL baseline and follow-up health questionnaire as follows: 1.1. Marital status, employment status and financial status are using the PIMMS-WL baseline health questionnaire collected at baseline 1.2. Smoking status and alcohol consumption are measured using the PIMMS-WL baseline and follow-up health questionnaire at baseline and 3 months post baseline 1.3. Data relating to participants’ type of delivery, pregnancy complications and how many children they have given birth to will be measured using the PIMMS-WL baseline health questionnaire at baseline 1.4. Attendance on any formal weight loss programmes during their involvement in the trial and any specific weight loss strategies or diets that participants might have used are measured using the PIMMS-WL baseline and follow-up health questionnaire at baseline and 3 months post baseline 1.5. Data relating to timing of cessation of breastfeeding, infant feeding practices and sleeping patterns of the mother are collected using the PIMMS-WL baseline and follow-up health questionnaire at baseline and 3 months post baseline 2. Weight, BMI and body fat are assessed using a Tanita SC-240MA analyser measured at baseline and at 3 months post baseline 3. Depression and anxiety will be measured using the Hospital Anxiety and Depression scale (HADS) at baseline and at 3 months post baseline 4. Self-reported physical activity are measured using the Pregnancy Physical Activity Questionnaire (PPAQ) at baseline and at 3 months post baseline 5. Bo | — |
Countries
England, United Kingdom
Outcome results
None listed