Recruiting and retaining postpartum women from areas of social disadvantage in a weight-loss trial (WeighWell) - insights and challenges Annie S. Anderson Maureen Macleod Karen L Barton Shaun Treweek Angela M. Craigie and the Weighwelll TEam

WeighWell: Platform study of post-partum weight loss Aims To evaluate the feasibility of undertaking an RCT of a weight loss intervention in 60 postpartum women living in areas of social disadvantage Objectives To examine Recruitment and early retention Recruitment and early retention Feasibility of assessment measures Feasibility of assessment measures Intervention delivery Intervention delivery Potential efficacy Potential efficacy

Background Pregnancy High risk period for excess weight gain and subsequent weight retention High risk period for excess weight gain and subsequent weight retention At 6-18 months 15-20% of women have retained at least 5kg. At 6-18 months 15-20% of women have retained at least 5kg. Women living in deprived communities Women living in deprived communities How to increase activities How to increase activities Restrict food intake Restrict food intake Demands of parenting Demands of parenting

Risks of inter-pregnancy weight gain* to mother and baby Villamor E and Cnattingius S. Lancet 2006; 368(9542): *within healthy BMI range

Post-partum: an ideal time for weight loss intervention? Pros: Improved well-being Improved well-being Improved ability to cope with demands of parenting Improved ability to cope with demands of parenting Opportunity to promote future family health Opportunity to promote future family health Critical opportunity for development of new behaviours and social networks Critical opportunity for development of new behaviours and social networksCons: Lack of time and energy Home based Demands of child rearing Multiple physical and mental symptoms Social isolation Feelings of guilt for personal needs

3 face to face visits + 3 telephone calls Motivational interviewing Personalised -500kcal diet prescription Physical activity goals (towards 150 mins moderate-vigorous activity / week Pedometer, walking plans, weight logbook for self monitoring Study design Recruitment Baseline assessments Randomisation Intervention GroupComparison Group 12 week follow up assessments Exit interview WeighWell programme Weight loss booklet to all Visits to Community groups Writing to GP practices in most deprived areas Writing to Health visitors in SIMD* deciles 1 to 5 Newspaper advertising Posters in Community settings Inclusion criteria: BMI ≥ 25kg/m2 BMI ≥ 25kg/m2 SIMD* 1-5 and in Tayside SIMD* 1-5 and in Tayside 6-18 months postpartum 6-18 months postpartum Not pregnant and no medical contraindications Not pregnant and no medical contraindications *Scottish Index of Multiple Deprivation (1=most deprived) Height, weight, waist circumference and skinfold measures Fasting blood sample (plasma Vit. C) Physical activity assessment using a SenseWear monitor Questionnaires on socio-demographic background, diet, physical activity, and psychosocial parameters Qualitative one-to-one interviews on the study experience (end of the study only)

Recruitment strategy (6 months) Location (in areas of social disadvantage) Number Poster/ “business cards”Local pharmacies32 Supermarkets and local shops28 Local halls / libraries/sports centres40 Family centres/Children groups10 Post Offices, Community notice boards7 Medical Centres7 Newspaper advertising Local press2 Community newsletter1 Visits to community groups 39 Letters sent to:Postpartum women (via NHS Tayside)472 Focus group participants (earlier study)18 GP surgeries (Health Visitor/GP/Practice Nurse) 15

Results

Recruitment and Retention Loss to follow up 24% Loss to follow up 39 %

Potential Efficacy Intervention GroupComparison Group P Baseline n=29 Follow-up n=22 Diff. n=22 P Baseline n=23 Follow-up n=14 Diff. n=14 P Weight (kg) 83.5± 12.8 ( ) 82.0± 13.5 ( ) -1.6± ± 14.8 ( ) 82.1± 14.0 ( ) 0.2± Waist (cm) 98.2± 11.2 ( ) 94.1± 11.6 ( ) -4.4± 3.5< ± 10.9 ( ) 97.2± 11.8 ( ) -2.8± BMI (kg/m 2 ) 31.6± 4.7 ( ) 30.7± 4.7 ( ) -0.7± 0.8< ± 5.4 ( ) 30.7± 4.3 ( ) 0.1± % Body Fat 33.3± 2.6 ( ) 32.0± 2.4 ( ) -1.5± 0.8< ± 2.8 ( ) 34.5± 2.6 ( ) -0.5±

Post-study feedback All reported experience positively But… many control group participants disappointed about allocation But… many control group participants disappointed about allocation “Yeah. I think I wasted that three months” Absolutely fine.. I knew from the beginning I suppose is the kind of, nature of the beast, but I don’t know if I kind or really took that on board at the time. I kind of expected a bit more.

Conclusions Potential efficacy demonstrated Control +0.2kg vs. Intervention -1.6kg Control +0.2kg vs. Intervention -1.6kg Several challenges: Recruitment Recruitment Most effective methods – community group visits, posters / cards, direct mailing Sufficient interest, but difficulty reaching target group (less than half eligible) Other opportunities? Ante natal care onwards, closer NHS link Retention Retention Lower in comparison group (61% vs. 75%) Subject burden Subject burden SenseWear monitors problematic, visits for blood samples True control group True control group WeighWell intervention merits testing in an RCT but not without improvements to recruitment and retention

Aim To develop and test new recruitment and retention strategies in order to recruit 60 women from areas of social disadvantage over 6 months To retain at least 70% (in both groups) …Prior to submitting a proposal for a full RCT of the WeighWell intervention

New recruitment sources GPs Personalised invitation letter sent via the GP Personalised invitation letter sent via the GP Health visitors Recruitment “business cards”, and study info given to mums at first immunisations (+ any other contact) Recruitment “business cards”, and study info given to mums at first immunisations (+ any other contact) Healthy start  focus on community pharmacies and retailers registered for Healthy Start vitamin supplies and voucher redemption.  focus on community pharmacies and retailers registered for Healthy Start vitamin supplies and voucher redemption.

New recruitment strategies Improved Contact  opportunities to contact the study team by text and .  opportunities to contact the study team by text and . Recruitment material modification: Embed observational learning theory (modelling): Embed observational learning theory (modelling): Women learn about what to expect through the experience of others (WeighWell 1 participants) Highlight health messages Highlight health messages Reduced risks of future obstetric complications and chronic disease risk. Appeal to altruism: Appeal to altruism: Stress the benefit of participation for increasing our understanding of disease reduction Easy to follow more energy Feel better about the way I look

Improved telephone screening 18% WOMEN were excluded on self reported BMI 18% WOMEN were excluded on self reported BMI Comparison on what participants reported and actually weighed showed 68% of women had underestimated their BMI Invite women at lower BMI (24) because many will weigh more than reported

Retention strategies Increased convenience: Removal of blood sample Removal of blood sample Removal of SenseWear Removal of SenseWear Co-ordination of visits with community groups if possible Co-ordination of visits with community groups if possible Increased loyalty measures: Tokens of appreciation Tokens of appreciation Focus on the baby Focus on the baby

3 face to face visits + 3 telephone calls Motivational interviewing Personalised -500kcal diet prescription and physical activity goals Pedometer, walking plans, weight logbook for self monitoring Study design Recruitment Baseline assessments Randomisation Intervention GroupComparison Group 12 week follow up assessments Token of appreciation + Control group consultation + Exit interview WeighWell programme Weight loss booklet to all As described + previous successful methods (e.g. posters, community visits, newspaper adverts) Inclusion criteria:  BMI ≥ 25kg/m 2  SIMD 1-5 and in Tayside  6-12 months postpartum  Not pregnant and no medical contraindications contraindications Height, weight, waist circumference and bioelectrical impedance Physical activity assessment by questionnaire Questionnaires on socio-demographic background, diet, physical activity, and psychosocial parameters Qualitative one-to-one interviews on the study experience (end of the study only)