IES Platform: Scoping and feasibility preparation for an RCT on post partum weight loss (WeighWell)

Lead Research Organisation: University of Dundee
Department Name: Unlisted

Abstract

Obesity and resulting complications present a major challenge to global health. It is recognised that pregnancy is a life stage where excess weight gain may occur and that many women retain this weight throughout the post partum period (one year after birth). For the overweight mother, weight loss is desirable for her own well-being, to reduce the risk of obesity-related complications in further pregnancies and to promote future family health. The proposed research comprises scoping work (Phase 1) to inform the development of a theory- based, weight management programme (WeighWell) and an exploratory trial (Phase 2) to assess the feasibility of delivery and acceptability of the programme in post partum women living in low income areas.

Phase 1 involves interviews with stakeholders (e.g. health visitors, community pharmacists) and focus group discussions with mothers to identify potential recruitment opportunities and explore acceptability and preferences for the intervention design and delivery and the feasibility of basing a programme on successful approaches to diabetes. The Phase 2 trial will recruit 60 overweight (BMI 25kg/m2 ) post partum women living in Tayside for a 3 month intervention which will include dietary and activity assessments and specific, personalised goals for change. The intervention will aim to achieve a 5% weight loss through a modest energy deficit diet and 150 minutes of activity per week. Participants will also receive behavioural counselling and specific support mechanisms will be identified to assist compliance with the intervention aims.

Baseline and follow up measures (all participants) include psycho-social assessments, diet and physical activity records and measurements of body composition. In addition, participants will undertake in-depth interviews on the experience of taking part in the programme, acceptability and challenges involved in the intervention implementation.

The main output will be a protocol for the design and practical delivery of an intervention for a definitive randomised control trial, a feasible recruitment strategy and weight loss information to inform trial design. Process data relating to different components of the exploratory intervention will also be collected, and will inform future intervention designs.

Technical Summary

Obesity and associated co-morbidities of diabetes, cardiovascular disease and certain cancers present a major challenge to global health. It is recognised that pregnancy is a life stage where excess weight gain may occur and that the post partum period is often characterised by weight retention. For the overweight or obese mother, weight loss is desirable for her own well-being, to meeting the physical demands of parenting, to reduce the risk of obesity-related complications in further pregnancies and to promote future family health. However, the social patterning of obesity in women adds a further challenge to implementing acceptable, effective and sustainable management strategies. The proposed research comprises scoping work (Phase 1) to inform the development of a theory-based, weight management programme (WeighWell) and an exploratory trial (Phase 2) to assess the feasibility of delivery and acceptability of the programme in post partum women living in low income areas.

Phase 1 involves interviews with key stakeholders and focus group discussions with post partum women to identify potential recruitment routes and target group preferences for the intervention design and delivery. In addition, participants will be invited to discuss the possible use of a programme based on successful diabetes prevention programmes. The Phase 2 trial will recruit 60 post partum women with a BMI 25kg/m2 living in Tayside (30 for intervention arm) for a 3 month intervention which will include dietary and activity assessments and specific, personalised goals for change. Based on the diabetes prevention programmes (and any additional suggestions derived from phase 1) the intervention would aim to achieve a 5% weight loss through a nutrient dense, modest energy deficit diet and 150 minutes of activity per week. Participants will undertake a decisional balance analysis on each of the behaviour components and specific support mechanisms to increase self efficacy.

Baseline and follow up measures of all participants include psycho-social measures, anthropometric assessments, diet and physical activity records, plasma vitamin C and accelerometery. In-depth interviews will also explore the experiences of the intervention programme.

The main output will be a protocol for the design and delivery of an intervention for a definitive trial, a feasible recruitment strategy and weight loss information to inform a sample size calculation. Process data relating to different components of the exploratory intervention will also be collected and will inform future intervention designs.

Publications

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Andrews EJ (2015) 'I didn't know why you had to wait': an evaluation of NHS infant-feeding workshops amongst women living in areas of high deprivation. in Journal of human nutrition and dietetics : the official journal of the British Dietetic Association

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Jancey JM (2014) Dietary outcomes of a community based intervention for mothers of young children: a randomised controlled trial. in The international journal of behavioral nutrition and physical activity

 
Description Cel 36 funding of interventions to address maternal obesity
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Invited to membership of Scottish Gvt Scottish Cancer Taskforce
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description NICE Consultation on Weight management for mothers after childbirth'
Geographic Reach National 
Policy Influence Type Participation in advisory committee
 
Description NICE Healthy Start Expert Reference Group
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Scientific Advisory Committee on Nutrition group on maternal and child nutrtion
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description invitation to join Scottish Government committee on maternal nutritiona nd infant feeding survey
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description Chief Scientist Office (CSO) Health Services Reserach Committee
Amount £221,220 (GBP)
Funding ID CZH/4/745 
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 12/2012 
End 04/2014
 
Description NHS Tayside heath board
Amount £55,000 (GBP)
Organisation University of Dundee 
Sector Academic/University
Country United Kingdom
Start 11/2009 
End 02/2012
 
Description National Prevention Research Initiative (NPRI)
Amount £1,166,320 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 01/2010 
End 06/2013
 
Title Study materials - WeighWell 
Description Off the shelf" research materials specifically tailored to our target population were not available. Supporting educational, motivational and behavioural materials were devised a member of the study team. Study materials focused on home based, low cost solutions to enhance nutritional and physical activity status in postpartum women. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Study materials were found to be helpful and informative and to facilitate behavioural change towards healthy eating and physical activity. Materials included references to low cost community based activities to encourage group participation and support. 
 
Description Cel 36 funding for interventions to address maternal obesity 
Organisation NHS Tayside
Department Directorate of Public Health
Country United Kingdom 
Sector Hospitals 
PI Contribution Collaboration has been established as part of a steering committee in the planning stages of projects to address the Nutrition of Women of Childbearing Age, Pregnant Women and Children under 5 in disadvantaged areas CEL 36 (2008) - maternal obesity.
Impact Participating in a multi disciplinary steering committee to develop interventions to address maternal obesity. The group comprises midwives, public health dieticians and nutritionists, parentcraft educator,a weight management services coordinator, an obstetrician and an anaesthetist.
Start Year 2009
 
Description Healthy Eating and Lifestyle in Pregnancy (HELP) 
Organisation Cardiff University
Department School of Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution This is a cluster randomised trial evaluating the effectiveness of a weight management intervention in pregnancy on weight at 12 months following birth, gestational weight gain and pregnancy and birth outcomes. Professor Annie Anderson's experience and knowledge gained from the findings of the WeighWell study has enabled her to acts as an advisor on this project.
Impact Professor Anderson's experience on the WeighWell study has enabled her to act as a collaborator on this project and asisted the research team in securing their funding for the study.
Start Year 2009
 
Title WeighWell intervention 
Description The 12 week intervention used motivational interviewing techniques to promote a personalised energy deficit diet and increased physical activity, delivered by 3 face to face consultations plus 3 structured telephone calls. Body weight loss was achieved by 73% of the intervention group compared to 36% of the comparison group (Table 1). Weight loss of clinical significance (reduction of 5% body weight SIGN, 2010) was achieved by 9% of the intervention group, compared to 0% in the comparison group. Whilst the study was not powered to show change between intervention and comparator there was a significantly greater change in the intervention compared to the comparison group for body weight, BMI and % body fat. The feasibility phase of this intervention has been completed and funding is being sought for a definitive trial to provide an appropriately powered assessment of the efficacy of the intervention. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2010
Development Status On hold
Impact An assessment of the strategies used to recruit to and retain participants within the WeighWell feasibility study was performed in order to inform the design of a definitive RCT.The findings highlighted the challenge of recruitment for lifestyle trials in women from socially disadvantaged areas when trying to develop a robust evidence base for intervention effectiveness and emphasised the need to utilise a wide range of strategies beyond traditional NHS settings. 
 
Description Design and distribution of recruitment posters, business cards and newsletters 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Posters and business cards advertising the feasibility study were developed and distributed around Tayside to assist recruitment. They were distributed to shops, pharmacies, sports centres, community centres, and GP practices (for display and to pass directly to potential participants). Recruitment adverts have also been printed in community newsletters.

This has been our second most successful method of finding women interested in taking part in the study.
Year(s) Of Engagement Activity 2009
 
Description Patron for First Steps Nutrition Trust 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact chaired meeting related to maternal nutrition
Year(s) Of Engagement Activity 2016
 
Description Radio Scotland broadcast 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact NA
Year(s) Of Engagement Activity 2011
 
Description Recruitment presentations and discussions with post partum women 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Many community groups, e.g. parent and toddler groups and baby rhymetimes, have been visited to inform women about the feasibility study, the intervention programme that has been developed as a result of the formative work, and to recruit any of those who are interesetd in taking part.

To date, 43% of women interested in taking part in the study have been contacted via face to face contact at community groups.
Year(s) Of Engagement Activity 2009
 
Description Recruitment presentations to health visitors 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Attended a health visitor team meeting to present details about the study, our findings from our formative work, and to discuss whether they would be willing and able to help with recruitment of participants into the feasibility study by passing on details of the study to their patients. Around 12 health visitors were present. This has also been carried out on a less formal basis by visiting GP practices and speaking to the practice staff.

Several women have contacted the study team to take part in the study, having been told about it by their health visitor.
Year(s) Of Engagement Activity 2009