Recruiting and retaining Recruiting and retaining postpartum women from areas postpartum women from areas of social disadvantage in a of social disadvantage in a weight-loss trial (WeighWell) -weight-loss trial (WeighWell) -insights and challengesinsights and challenges

Annie S. AndersonAnnie S. AndersonMaureen MacleodMaureen MacleodKaren L BartonKaren L BartonShaun TreweekShaun TreweekAngela M. CraigieAngela M. Craigieand the Weighwelll TEamand the Weighwelll TEam

WeighWell: Platform study of WeighWell: Platform study of post-partum weight losspost-partum weight loss

AimsAimsTo evaluate the feasibility of To evaluate the feasibility of undertaking an RCT of a weight loss undertaking an RCT of a weight loss intervention in 60 postpartum women intervention in 60 postpartum women living in areas of social disadvantage living in areas of social disadvantage

ObjectivesObjectivesTo examineTo examine

Recruitment and early retention Recruitment and early retention Feasibility of assessment measuresFeasibility of assessment measures Intervention deliveryIntervention delivery Potential efficacyPotential efficacy

BackgroundBackground

PregnancyPregnancy High risk period for excess High risk period for excess

weight gain and weight gain and subsequent weight subsequent weight retentionretention

At 6-18 months 15-20% of At 6-18 months 15-20% of women have retained at women have retained at least 5kg. least 5kg.

Women living in deprived Women living in deprived communitiescommunities

How to increase activitiesHow to increase activities Restrict food intakeRestrict food intake Demands of parentingDemands of parenting

Risks of inter-pregnancy weight Risks of inter-pregnancy weight gain* to mother and babygain* to mother and baby

Gestationaldiabetes

Gestationalhypertension

Large for datebirth weight

Stillbirth

Caesareandelivery

Pre-eclampsia

BetweenPregnancy weight gain

Villamor E and Cnattingius S. Lancet 2006; 368(9542):1164-1170

*within healthy BMI range

Post-partum: an ideal time for Post-partum: an ideal time for weight loss intervention?weight loss intervention?

Pros:Pros: Improved well-beingImproved well-being Improved ability to Improved ability to

cope with demands of cope with demands of parentingparenting

Opportunity to Opportunity to promote future family promote future family healthhealth

Critical opportunity for Critical opportunity for development of new development of new behaviours and social behaviours and social networksnetworks

Cons:Cons: Lack of time and Lack of time and

energyenergy Home basedHome based Demands of child Demands of child

rearingrearing Multiple physical and Multiple physical and

mental symptomsmental symptoms Social isolationSocial isolation Feelings of guilt for Feelings of guilt for

personal needspersonal needs

3 face to face visits + 3 telephone calls3 face to face visits + 3 telephone callsMotivational interviewingMotivational interviewingPersonalised -500kcal diet prescriptionPersonalised -500kcal diet prescriptionPhysical activity goals (towards 150 Physical activity goals (towards 150 mins moderate-vigorous activity / weekmins moderate-vigorous activity / weekPedometer, walking plans, weight Pedometer, walking plans, weight logbook for self monitoringlogbook for self monitoring

Study Study designdesign

Recruitment

Baseline assessments

Randomisation

Intervention Group Comparison Group

12 week follow up assessments

Exit interview

WeighWell programme

Weight loss booklet to all

Visits to Community groupsVisits to Community groups

Writing to GP practices in most Writing to GP practices in most deprived areasdeprived areas

Writing to Health visitors in Writing to Health visitors in SIMD* deciles 1 to 5SIMD* deciles 1 to 5

Newspaper advertisingNewspaper advertising

Posters in Community settingsPosters in Community settings

Inclusion criteria:Inclusion criteria: BMI ≥ 25kg/m2BMI ≥ 25kg/m2 SIMD* 1-5 and in TaysideSIMD* 1-5 and in Tayside 6-18 months postpartum6-18 months postpartum Not pregnant and no medical Not pregnant and no medical

contraindicationscontraindications

*Scottish Index of Multiple *Scottish Index of Multiple Deprivation (1=most deprived)Deprivation (1=most deprived)

Height, weight, waist circumference and Height, weight, waist circumference and skinfold measures skinfold measures

Fasting blood sample (plasma Vit. C) Fasting blood sample (plasma Vit. C)

Physical activity assessment using a Physical activity assessment using a SenseWear monitor SenseWear monitor

Questionnaires on socio-demographic Questionnaires on socio-demographic background, diet, physical activity, and background, diet, physical activity, and psychosocial parameterspsychosocial parameters

Qualitative one-to-one interviews on the Qualitative one-to-one interviews on the study experience (end of the study only)study experience (end of the study only)

Recruitment strategy

(6 months)

Location

(in areas of social disadvantage)

Number

Poster/ “business cards” Local pharmacies 32

Supermarkets and local shops 28

Local halls / libraries/sports centres 40

Family centres/Children groups 10

Post Offices, Community notice boards 7

Medical Centres 7

Newspaper advertising Local press 2

Community newsletter 1

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

ResultsResults

Recruitment and RetentionRecruitment and Retention

Loss to follow up24%

Loss to follow up 39 %

Potential EfficacyPotential EfficacyIntervention Group Comparison Group

PBaseline

n=29Follow-up

n=22Diff.n=22

PBaseline

n=23Follow-up

n=14Diff.n=14

P

Weight (kg)

83.5± 12.8(64.4-112.3)

82.0± 13.5(63.0-110.8)

-1.6± 2.0 0.001 84.2± 14.8(59.1-120.8)

82.1± 14.0(58.3-100.1)

0.2± 2.2 0.77 0.018

Waist (cm)

98.2± 11.2(78.7-117.6)

94.1± 11.6(74.4-116.2)

-4.4± 3.5 <0.001 102.7± 10.9(83.0-133.0)

97.2± 11.8(83.9-126.3)

-2.8± 4.5

0.04 0.23

BMI (kg/m2)

31.6± 4.7(25.5-41.8)

30.7± 4.7(23.7-39.5)

-0.7± 0.8 <0.001 31.6± 5.4(25.3-47.8)

30.7± 4.3(25.4-37.2)

0.1± 0.9 0.75 0.009

% Body Fat

33.3± 2.6(28.3-39.1)

32.0± 2.4(29.1-38.1)

-1.5± 0.8 <0.001 34.0± 2.8(29.7-38.8)

34.5± 2.6(30.3-38.9)

-0.5± 1.4

0.32 0.029

Post-study feedbackPost-study feedback

All reported experience positivelyAll reported experience positively But… many control group participants disappointed But… many control group participants disappointed

about allocationabout 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.

ConclusionsConclusions

Potential efficacy demonstratedPotential efficacy demonstrated Control +0.2kg vs. Intervention -1.6kgControl +0.2kg vs. Intervention -1.6kg

Several challenges:Several challenges: RecruitmentRecruitment

Most effective methods – community group visits, posters / cards, Most effective methods – community group visits, posters / cards, direct mailingdirect mailingSufficient interest, but difficulty reaching target group (less than half Sufficient interest, but difficulty reaching target group (less than half eligible)eligible)Other opportunities? Ante natal care onwards, closer NHS linkOther opportunities? Ante natal care onwards, closer NHS link

RetentionRetentionLower in comparison group (61% vs. 75%)Lower in comparison group (61% vs. 75%)

Subject burdenSubject burdenSenseWear monitors problematic, visits for blood samplesSenseWear monitors problematic, visits for blood samples

True control groupTrue control group

WeighWell intervention merits testing in an RCT but not WeighWell intervention merits testing in an RCT but not without improvements to recruitment and retentionwithout improvements to recruitment and retention

AimAim

To develop and test To develop and test new recruitment and new recruitment and retention strategiesretention strategies in order to recruit 60 in order to recruit 60 women from areas of social disadvantage women from areas of social disadvantage over 6 monthsover 6 months

To retain at least 70% (in both groups) To retain at least 70% (in both groups)

……Prior to submitting a proposal for a full Prior to submitting a proposal for a full RCT of the WeighWell intervention RCT of the WeighWell intervention

New recruitment sourcesNew recruitment sources

GPsGPs Personalised invitation letter Personalised invitation letter

sent via the GP sent via the GP

Health visitorsHealth visitors Recruitment “business Recruitment “business

cards”, and study info given cards”, and study info given to mums at first to mums at first immunisations (+ any other immunisations (+ any other contact)contact)

Healthy start Healthy start focus on community focus on community

pharmacies and retailers pharmacies and retailers registered for Healthy Start registered for Healthy Start vitamin supplies and voucher vitamin supplies and voucher redemption.redemption.

New recruitment strategiesNew recruitment strategies

Improved ContactImproved Contact opportunities to contact the study team by opportunities to contact the study team by

text and email.text and email.

Recruitment material modificationRecruitment material modification:: Embed observational learning theory Embed observational learning theory

(modelling):(modelling):Women learn about what to expect through the Women learn about what to expect through the experience of others (WeighWell 1 participants)experience of others (WeighWell 1 participants)

Highlight health messagesHighlight health messagesReduced risks of future obstetric complications Reduced risks of future obstetric complications and chronic disease risk. and chronic disease risk.

Appeal to altruism:Appeal to altruism:Stress the benefit of participation for increasing Stress the benefit of participation for increasing our understanding of disease reductionour understanding of disease reduction

Easy to followEasy to follow

more energymore energy

Feel better about Feel better about the way I lookthe way I look

Improved telephone screeningImproved telephone screening

18% WOMEN were excluded on self 18% WOMEN were excluded on self reported BMIreported BMI

Comparison on what participants reported Comparison on what participants reported and actually weighed showed 68% of and actually weighed showed 68% of women had underestimated their BMIwomen had underestimated their BMI

Invite women at lower BMI (24) because Invite women at lower BMI (24) because many will weigh more than reportedmany will weigh more than reported

Retention strategiesRetention strategies

Increased convenience:Increased convenience: Removal of blood sampleRemoval of blood sample Removal of SenseWearRemoval of SenseWear Co-ordination of visits with Co-ordination of visits with

community groups if community groups if possiblepossible

Increased loyalty Increased loyalty measures:measures: Tokens of appreciationTokens of appreciation Focus on the babyFocus on the baby

3 face to face visits + 3 telephone calls3 face to face visits + 3 telephone callsMotivational interviewingMotivational interviewingPersonalised -500kcal diet prescription Personalised -500kcal diet prescription and physical activity goalsand physical activity goalsPedometer, walking plans, weight Pedometer, walking plans, weight logbook for self monitoringlogbook for self monitoring

Study Study designdesign

Recruitment

Baseline assessments

Randomisation

Intervention Group Comparison 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 As described + previous successful methods (e.g. posters, community methods (e.g. posters, community visits, newspaper adverts)visits, newspaper adverts)

Inclusion criteria:Inclusion criteria: BMI ≥ 25kg/mBMI ≥ 25kg/m22

SIMD 1-5 and in TaysideSIMD 1-5 and in Tayside 6-126-12 months postpartum months postpartum Not pregnant and no medical Not pregnant and no medical contraindicationscontraindications

Height, weight, waist circumference and Height, weight, waist circumference and bioelectrical impedancebioelectrical impedance

Physical activity assessment by Physical activity assessment by questionnairequestionnaire

Questionnaires on socio-demographic Questionnaires on socio-demographic background, diet, physical activity, and background, diet, physical activity, and psychosocial parameterspsychosocial parameters

Qualitative one-to-one interviews on the Qualitative one-to-one interviews on the study experience (end of the study only)study experience (end of the study only)