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Supporting postpartum weight loss in women living in deprived communities: design implications for a randomised control trial.

ABSTRACT: Pregnancy is a life stage where excess weight gain may occur and the postpartum period is often characterised by weight retention. The aim of the current study was to evaluate the feasibility of undertaking a randomised controlled trial of a weight loss intervention (WeighWell) in postpartum women living in areas of social disadvantage.The study aimed to recruit 60 women who were not pregnant, 6-18 months postpartum with a body mass index >25 kg/m(2) living in areas of deprivation within Tayside, UK. Recruitment strategies focused on visits to community groups; writing directly to postpartum women living in areas of deprivation and primary care teams who covered the most deprived 15% of the population and advertising in community settings. The 12-week intervention used motivational interviewing techniques to promote an energy deficit diet and increased physical activity, delivered by three face-to-face consultations plus three structured telephone calls.Of 142 women screened, 63 were eligible and 52 (83%) were recruited and randomised to an intervention (n=29) or comparison group (n=23). Over the 12-week intervention, body weight changed significantly by -1.6 ± 2.0 kg in the intervention group compared with +0.2 ± 2.2 kg in the comparison group, indicating the potential efficacy of the intervention. Loss to follow-up was 24% in the intervention group and 39% for the comparison group.The findings support the development of a definitive trial that embraces personalised recruitment strategies and the development of approaches to improve retention over a clinically relevant intervention period.

SUBMITTER: Craigie AM

PROVIDER: S-EPMC3154650 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Supporting postpartum weight loss in women living in deprived communities: design implications for a randomised control trial.

Craigie A M AM Macleod M M Barton K L KL Treweek S S Anderson A S AS

European journal of clinical nutrition 20110511 8

<h4>Background/objectives</h4>Pregnancy is a life stage where excess weight gain may occur and the postpartum period is often characterised by weight retention. The aim of the current study was to evaluate the feasibility of undertaking a randomised controlled trial of a weight loss intervention (WeighWell) in postpartum women living in areas of social disadvantage.<h4>Subjects/methods</h4>The study aimed to recruit 60 women who were not pregnant, 6-18 months postpartum with a body mass index >2 ...[more]

PMID: 21559034

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Project description:BackgroundLong-term weight maintenance after weight loss is challenging, and innovative solutions are required. Digital technologies can support behavior change and, therefore, have the potential to be an effective tool for weight loss maintenance. However, to create meaningful and effective digital behavior change interventions that support end user values and needs, a combination of persuasive system design (PSD) principles and behavior change techniques (BCTs) might be needed.ObjectiveThis study aimed to investigate how an evidence-informed digital behavior change intervention can be designed and developed by combining PSD principles and BCTs into design features to support end user values and needs for long-term weight loss maintenance.MethodsThis study presents a concept for how PSD principles and BCTs can be translated into design features by combining design thinking and Agile methods to develop and deliver an evidence-informed digital behavior change intervention aimed at supporting weight maintenance. Overall, 45 stakeholders participated in the systematic and iterative development process comprising co-design workshops, prototyping, Agile development, and usability testing. This included prospective end users (n=17, 38%; ie, people with obesity who had lost ≥8% of their weight), health care providers (n=9, 20%), healthy volunteers (n=4, 9%), a service designer (n=1, 2%), and stakeholders from the multidisciplinary research and development team (n=14, 31%; ie, software developers; digital designers; and eHealth, behavior change, and obesity experts). Stakeholder input on how to operationalize the design features and optimize the technology was examined through formative evaluation and qualitative analyses using rapid and in-depth analysis approaches.ResultsA total of 17 design features combining PSD principles and BCTs were identified as important to support end user values and needs based on stakeholder input during the design and development of eCHANGE, a digital intervention to support long-term weight loss maintenance. The design features were combined into 4 main intervention components: Week Plan, My Overview, Knowledge and Skills, and Virtual Coach and Smart Feedback System. To support a healthy lifestyle and continued behavior change to maintain weight, PSD principles such as tailoring, personalization, self-monitoring, reminders, rewards, rehearsal, praise, and suggestions were combined and implemented into the design features together with BCTs from the clusters of goals and planning, feedback and monitoring, social support, repetition and substitution, shaping knowledge, natural consequences, associations, antecedents, identity, and self-belief.ConclusionsCombining and implementing PSD principles and BCTs in digital interventions aimed at supporting sustainable behavior change may contribute to the design of engaging and motivating interventions in line with end user values and needs. As such, the design and development of the eCHANGE intervention can provide valuable input for future design and tailoring of evidence-informed digital interventions, even beyond digital interventions in support of health behavior change and long-term weight loss maintenance.Trial registrationClinicalTrials.gov NCT04537988; https://clinicaltrials.gov/ct2/show/NCT04537988.

Project description:BackgroundCancer survival rates in the UK are lower in comparison with similar countries in Europe and this may be linked to socioeconomic inequalities in stage of cancer diagnosis and survival. Targeted cancer awareness interventions have the potential to improve earlier symptomatic diagnosis and reduce socioeconomic inequalities in cancer outcomes. The health check is an innovative, theory-based intervention designed to increase awareness of cancer symptoms and risk factors, and encourage timely help seeking among adults living in deprived communities.MethodsA prospective, non-randomised evaluation was undertaken to test the feasibility and acceptability of the health check for adults aged 40 years and over living in deprived areas of Wales. Primary outcomes included recruitment and retention of approximately 100 adults, reach to participants in the lowest deprivation quartile, and intervention acceptability. Secondary outcomes included self-reported cancer symptom recognition, help-seeking behaviours and state anxiety pre/post intervention.ResultsOf 185 individuals approached, 98 (53%) completed the intervention. Sixty-six of 98 participants were recruited from community settings (67%) and 32 from healthcare settings (33%), with 56 (57%) from the lowest deprivation quartile. Eighty-three (85%) participants completed follow-up assessment. Participants recognised on average one extra cancer symptom post intervention, with improved recognition of and anticipated presentation for non-specific symptoms. State anxiety scores remained stable. Qualitative interviews (n = 25) demonstrated that the intervention was well received and motivated change.ConclusionsRecruitment was feasible in community and healthcare settings, with good reach to adults from low socioeconomic groups. The health check intervention was acceptable and demonstrated potential for improved cancer awareness and symptom presentation, especially for non-specific symptoms, in communities most affected by cancer.

Project description:BackgroundOverweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women.Methods/designStudy participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI) ≥ 27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase.DiscussionThe Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics.Trial registrationclinicaltrials.gov NCT02176915 . Registered 25 June 2014.

Project description:Introduction: Free-living movement (physical activity [PA] and sedentary behavior [SB]) and eating behaviors (energy intake [EI] and food choice) affect energy balance and therefore have the potential to influence weight loss (WL). This study explored whether free-living movement and/or eating behaviors measured early (week 3) in a 14-week WL programme or their change during the intervention are associated with WL in women. Methods: In the study, 80 women (M ± SD age: 42.0 ± 12.4 years) with overweight or obesity [body mass index (BMI): 34.08 ± 3.62 kg/m2] completed a 14 week WL program focused primarily on diet (commercial or self-led). Body mass (BM) was measured at baseline, and again during week 2 and 14 along with body composition. Free-living movement (SenseWear Armband) and eating behavior (weighed food diaries) were measured for 1 week during week 3 and 12. Hierarchical multiple regression analyses examined whether early and early-late change in free-living movement and eating behavior were associated with WL. The differences in behavior between clinically significant weight losers (CWL; ≥5% WL) and non-clinically significant weight losers (NWL; ≤ 3% WL) were compared. Results: The energy density of food consumed [β = 0.45, p < 0.001] and vigorous PA [β = -0.30, p < 0.001] early in the intervention (regression model 1) and early-late change in light PA [β = -0.81 p < 0.001], moderate PA [β = -1.17 p < 0.001], vigorous PA [β = -0.49, p < 0.001], total energy expenditure (EE) [β = 1.84, p < 0.001], and energy density of food consumed [β = 0.27, p = 0.01] (regression model 2) significantly predicted percentage change in BM. Early in the intervention, CWL consumed less energy dense foods than NWL [p = 0.03]. CWL showed a small but significant increase in vigorous PA, whereas NWL showed a slight decrease in PA [p = 0.04]. Conclusion: Both early and early-late change in free-living movement and eating behaviors during a 14 week WL program are predictors of WL. These findings demonstrate that specific behaviors that contribute to greater EE (e.g., vigorous PA) and lower EI (e.g., less energy-dense foods) are related to greater WL outcomes. Interventions targeting these behaviors can be expected to increase the effectiveness of WL programs.

Project description:BackgroundBreastfeeding is associated with significant positive health outcomes for mothers and infants. However, despite recommendations from the World Health Organization, exclusive breastfeeding for six months is uncommon. Increased breastfeeding support early in the postpartum period may be effective in improving breastfeeding maintenance. This trial will evaluate two community-based interventions to increase breastfeeding duration in Local Government Areas (LGAs) in Victoria, Australia.Methods/designA three-arm cluster randomised controlled trial design will be used. Victorian LGAs with a lower than average rate of any breastfeeding at discharge from hospital and more than 450 births per year that agree to participate will be randomly allocated to one of three trial arms: 1) standard care; 2) home-based breastfeeding support; or 3) home-based breastfeeding support plus access to a community-based breastfeeding drop-in centre. The services provided in LGAs allocated to 'standard care' are those routinely available to postpartum women. LGAs allocated to the home-based visiting intervention will provide home-visits to women who are identified as at risk of breastfeeding cessation in the early postnatal period. These visits will be provided by Maternal and Child Health Nurses who have received training to provide the intervention (SILC-MCHNs). In areas allocated to receive the second intervention, in addition to home-based breastfeeding support, community breastfeeding drop-in centres will be made available, staffed by a SILC-MCHN. The interventions will run in LGAs for a nine to twelve month period depending on birth numbers. The primary outcome is the proportion of infants receiving any breast milk at four months of age. Breastfeeding outcomes will be obtained from routinely collected Maternal and Child Health centre data and from a new data item collecting infant feeding 'in the last 24 hours'. Information will also be obtained directly from women via a postal survey. A comprehensive process evaluation will be conducted.DiscussionThis study will determine if early home-based breastfeeding support by a health professional for women at risk of stopping breastfeeding, with or without access to a community-based breastfeeding drop-in centre, increases breastfeeding duration in Victorian LGAs with low breastfeeding rates.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12611000898954.

Dataset Information

Supporting postpartum weight loss in women living in deprived communities: design implications for a randomised control trial.

Publications

Supporting postpartum weight loss in women living in deprived communities: design implications for a randomised control trial.

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