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GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

ABSTRACT: Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines.GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial.This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness.ISRCTN46869894; retrospectively registered 25th May 2016.

SUBMITTER: Heslehurst N

PROVIDER: S-EPMC5807844 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

Heslehurst Nicola N Rankin Judith J McParlin Catherine C Sniehotta Falko F FF Howel Denise D Rice Stephen S McColl Elaine E

Pilot and feasibility studies 20180209

<h4>Background</h4>Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity W ...[more]

PMID: 29456871

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Project description:BackgroundGestational weight interventions are important in maternity care to counteract adverse pregnancy events. However, qualitative findings indicate potential obstacles in the implementation of interventions due to the sensitivity of the subject and existing obesity stigma. Pregnant women have reported disrespectful or unhelpful communication, while some midwives seem to avoid the topic, as not to upset women. This descriptive study aimed to provide knowledge about maternity care providers' beliefs about obesity, and their attitudes towards gestational weight management.MethodA web survey was emailed to Swedish maternity care clinics. Existing questionnaires, "Beliefs About Obese People" (BAOP), "Perceived weight bias in health care" and "Attitudes toward obese patients" was used, supplemented with questions formulated for this study. An open free-text question allowed participants to provide a deeper and more nuanced picture of the topic.Results274 respondents (75% midwives and 25% obstetricians) participated. One third of respondents found obesity to be a more sensitive topic than smoking or alcohol habits, and 17% of midwives agreed to the statement: "I sometimes avoid talking about weight so as not to make the pregnant woman worried or ashamed". Having had training in motivational interviewing seemed positively associated with midwives' inclination to talk about body weight, especially with women with obesity (p = .001), whereas years of working experience were not associated. Having received obesity education increased confidence in providing adequate information, but still only 46% felt they had enough knowledge to provide diet and exercise advice to pregnant women with obesity. Qualitative data revealed great empathy for women with obesity, and a wish to have more obesity education and access to other professionals.ConclusionSwedish maternity care staff displayed empathy for women with obesity and found gestational weight interventions important, but almost one fifth of midwives sometimes avoid the subject of body weight for fear of upsetting women. Education about obesity facts, training in person-centered communication, i.e. motivational interviewing, and access to dieticians may facilitate gestational weight management implementation.

Project description:BackgroundObesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enable targeted intervention in women with obesity who would benefit the most. The aim of this study is to identify pregnant women with obesity at higher risk of developing GDM and, in a pilot randomised controlled trial (RCT), test feasibility and assess the efficacy of a lifestyle intervention and/or metformin to improve glycaemic control.MethodsWomen aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥ 30kg/m2 will be recruited from one maternity unit in London, UK. The risk of GDM will be assessed using a multivariable GDM prediction model combining maternal age, mid-arm circumference, systolic blood pressure, glucose, triglycerides and HbA1c. Women identified at a higher risk of developing GDM will be randomly allocated to one of two intervention groups (lifestyle advice with or without metformin) or standard antenatal care. The primary feasibility outcomes are study recruitment, retention rate and intervention adherence and to collect information needed for the sample size calculation for the definitive trial. A process evaluation will assess the acceptability of study processes and procedures to women. Secondary patient-centred outcomes include a reduction in mean glucose/24h of 0.5mmol/l as assessed by continuous glucose monitoring and changes in a targeted maternal metabolome, dietary intake and physical activity. A sample of 60 high-risk women is required.DiscussionEarly risk stratification of GDM in pregnant women with obesity and targeted intervention using lifestyle advice with or without metformin could improve glucose tolerance compared to standard antenatal care. The results from this feasibility study will inform a larger adequately powered RCT should the intervention show trends for potential effectiveness.Trial registrationThis study has been approved by the NHS Research Ethics Committee (UK IRAS integrated research application system; reference 18/LO/1500). EudraCT number 2018-000003-16 .

Project description:Obesity is a chronic metabolic disease characterised by an increase of body fat stores. It is a gateway to ill health, and it has become one of the leading causes of disability and death, affecting not only adults but also children and adolescents worldwide. In clinical practice, the body fatness is estimated by BMI, and the accumulation of intra-abdominal fat (marker for higher metabolic and cardiovascular disease risk) can be assessed by waist circumference. Complex interactions between biological, behavioural, social and environmental factors are involved in regulation of energy balance and fat stores. A comprehensive history, physical examination and laboratory assessment relevant to the patient's obesity should be obtained. Appropriate goals of weight management emphasise realistic weight loss to achieve a reduction in health risks and should include promotion of weight loss, maintenance and prevention of weight regain. Management of co-morbidities and improving quality of life of obese patients are also included in treatment aims. Balanced hypocaloric diets result in clinically meaningful weight loss regardless of which macronutrients they emphasise. Aerobic training is the optimal mode of exercise for reducing fat mass while a programme including resistance training is needed for increasing lean mass in middle-aged and overweight/obese individuals. Cognitive behavioural therapy directly addresses behaviours that require change for successful weight loss and weight loss maintenance. Pharmacotherapy can help patients to maintain compliance and ameliorate obesity-related health risks. Surgery is the most effective treatment for morbid obesity in terms of long-term weight loss. A comprehensive obesity management can only be accomplished by a multidisciplinary obesity management team. We conclude that physicians have a responsibility to recognise obesity as a disease and help obese patients with appropriate prevention and treatment. Treatment should be based on good clinical care, and evidence-based interventions; should focus on realistic goals and lifelong multidisciplinary management.

Project description:ObjectivesNew clinical practice guidelines for the management of mild traumatic brain injury (mTBI) emphasise that family physicians should proactively screen and initiate treatment for depression/anxiety, insomnia and headaches. This study aimed to evaluate the feasibility of delivering an implementation intervention to family physicians.DesignPilot cluster randomised controlled trial.SettingSpecialty outpatient clinic (recruitment) and primary care (implementation).Participants114 primary care clinics were randomised. These clinics were associated with 137 unique family physicians caring for 148 adult patients who sustained an mTBI within the previous 3 months and were seeking care for persistent symptoms.InterventionsPatients completed self-report screening measures for depression/anxiety, insomnia and headaches. A tailored letter that incorporates the patient's screening test results and associated treatment algorithms was sent to their family physician (or walk-in clinic). Physicians at clinics assigned to the control condition received a generic letter, without the screening test results.Primary outcome measuresFeasibility outcomes included the frequency of primary care follow-up, retention rates and reliability of patient recall of their physicians' actions (primary mechanistic outcome). The primary efficacy outcome was the Rivermead Post-Concussion Symptom Questionnaire (RPQ).ResultsMost patients (97.8%; 128 of 131) followed up at the primary care clinic they planned to. Retention rates were 88% (131 of 148) and 78% (116 of 148) at the 1-month and 3-month assessments, respectively. Agreement between patient recall of their physicians' actions and medical chart audits was moderate (intraclass correlation coefficient=0.48-0.65). Patients in the experimental group reported fewer symptoms on the RPQ compared with those in the control group, whose physician received a general letter (B=-4.0, 95% CI: -7.3 to -0.7).ConclusionsA larger trial will need to address minor feasibility challenges to evaluate the effectiveness of this guideline implementation tool for improving mTBI clinical outcomes and confirm the mechanism(s) of intervention benefit.Trial registration numberNCT03221218.

Project description:BackgroundIn 2016, the UK Chief Medical Officers revised their guidance on alcohol and advised women to abstain from alcohol if pregnant or planning pregnancy. Midwives have a key role in advising women about alcohol during pregnancy. The aim of this study was to investigate UK midwives' practices regarding the 2016 Chief Medical Officers Alcohol Guidelines for pregnancy, and factors influencing their implementation during antenatal appointments.MethodsOnline cross-sectional survey of a convenience sample of UK midwives recruited through professional networks and social media. Data were gathered using an anonymous online questionnaire addressing knowledge of the 2016 Alcohol Guidelines for pregnancy; practice behaviours regarding alcohol assessment and advice; and questions based on the Theoretical Domains Framework (TDF) to evaluate implementation of advising abstinence at antenatal booking and subsequent antenatal appointments.ResultsOf 842 questionnaire respondents, 58% were aware of the 2016 Alcohol Guidelines of whom 91% (438) cited abstinence was recommended, although 19% (93) cited recommendations from previous guidelines. Nonetheless, 97% of 842 midwives always or usually advised women to abstain from alcohol at the booking appointment, and 38% at subsequent antenatal appointments. Mean TDF domain scores (range 1-7) for advising abstinence at subsequent appointments were highest (indicative of barriers) for social influences (3.65 sd 0.84), beliefs about consequences (3.16 sd 1.13) and beliefs about capabilities (3.03 sd 073); and lowest (indicative of facilitators) for knowledge (1.35 sd 0.73) and professional role and identity (1.46 sd 0.77). Logistic regression analysis indicated that the TDF domains: beliefs about capabilities (OR = 0.71, 95% CI: 0.57, 0.88), emotion (OR = 0.78; 95%CI: 0.67, 0.90), and professional role and identity (OR = 0.69, 95%CI 0.51, 0.95) were strong predictors of midwives advising all women to abstain from alcohol at appointments other than at booking.ConclusionsOur results suggest that skill development and reinforcement of support from colleagues and the wider maternity system could support midwives' implementation of alcohol advice at each antenatal appointment, not just at booking could lead to improved outcomes for women and infants. Implementation of alcohol care pathways in maternity settings are beneficial from a lifecourse perspective for women, children, families, and the wider community.

Dataset Information

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

Publications

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

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