Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative.

Abstract

Introduction Obesity is a clinical and public health epidemic. In most populations, women contribute more to the prevalence of obesity in adults than their male counterparts. The biopsychosocial changes experienced during various stages of the reproductive cycle might implicate excessive weight gain in women.[1] One such high-risk reproductive stage for gaining weight is the menopause transition experienced during midlife. In addition to biological transition, midlife women experience changes in their everyday lifestyle-related habits in a way that might promote unhealthy eating habits, sedentary lifestyles, and distress in the face of household and work responsibilities.[2] Further, weight gain promotes menopausal symptom severity, making it difficult to maintain healthy lifestyle-related behaviours and health-related quality of life.[3] The introduction of corrective lifestyle-related habits has proven beneficial in managing weight and menopausal health.[4] Corrective lifestyle habits such as healthy dietary behaviour, physically active lifestyle, and psychological well-being are necessary for successful weight management. Most midlife women lack the motivation to initiate corrective practices as they prioritise their roles as mothers, homemakers, and workers over their own health. Besides, factors including poor musculoskeletal health, limited physical function, menstrual irregularities, and psychological distress interfere with adopting healthy lifestyle practices.[5] Considering these factors, it becomes necessary to incorporate strategies to address midlife-specific barriers while managing obesity in this group of women to initiate and sustain weight loss efforts. Generally, midlife women receive generic weight management advice from healthcare professionals.[6] This advice is less actionable, so it rarely contributes towards correcting the existing lifestyle-related behaviours in midlife women. In contrast, comprehensive obesity care also lacks specificity to address issues faced by midlife women in managing weight and overall health. This care can be provided by a team of clinicians such as gynaecologists, physicians, and allied healthcare professionals, including nutritionists and exercise physiologists. The availability of such a team in the healthcare setting might be limited, especially in developing countries.[7] This underscores the need for the development of evidence and consensus-based recommendations related to diet, physical activity, and behaviour, which can be used by clinicians and/or any other healthcare provider for opportunistic management of overweight and obesity in midlife women. Methods The development and validation of the guideline were initiated to address the need for protocolised weight management measures specific to midlife women that can be implemented in day-to-day clinical practice at different healthcare settings. The guidelines were developed in two phases using standardised methodology as per the National Health and Medical Research Council (NHMRC): (i) development of recommendations and (ii) validation of the developed recommendations. Firstly, an exhaustive list of key clinical questions through literature search, expert opinion, and Delphi method was identified to be addressed by the guideline. In Phase I, a systematic review of the evidence, grading, and expert opinion were undertaken to formulate clinical practice recommendations for each clinical question. In Phase II, the clinical practice recommendations were peer-reviewed and validated using the Delphi method and graded using the GRADE approach via the experts participating in the Guideline Development Group (GDG). Guideline Development Group (GDG) Expert representatives from multidisciplinary fields including medicine, gynecology, psychology, psychiatry, physical medicine and rehabilitation, nutrition, and exercise physiology were part of the GDG. Further, chairperson and field experts from prominent national organisations such as the Department of Science and Technology, the Federation of Obstetric and Gynaecological Societies of India, Indian Menopause Society, Association of Physicians of India, Academy of Family Physicians of India, Association of Obstetricians & Gynaecologists of Delhi, Indian Dietetic Association, and the Indian Society of Clinical Nutrition also participated in the GDG. From academia, senior professors across five leading medical colleges of the country participated in the proceedings of GDGs. The role and responsibilities of a member of the GDG included finalisation and prioritisation of key clinical questions to be addressed in guideline, review of the available evidence, providing expert opinion, development of the recommendation for each clinical question, validation of the developed recommendations, and grading of the final recommendations. Development and prioritization of key clinical question Initially, a series of exploratory focus group discussions were conducted to identify the risk factors, barriers, and facilitators for appropriate weight management among midlife women.[8] Secondly, a comprehensive, valid and reliable screening tool was designed to evaluate the lifestyle-related practices and barriers faced in maintaining healthy eating, physical activity, and sleep practices. Finally, a cross-sectional survey on 504 midlife women was conducted to identify the daily lifestyle-related patterns and their association with menopausal symptom severity. These steps guided the team in identifying key critical areas that should be addressed for appropriate weight management in midlife women. In addition, an exhaustive literature review was conducted to determine key clinical areas of interest for translation into key clinical questions. Based on the stages of weight management, a comprehensive list of key clinical questions was classified into four domains: (i) initiation of discussion for weight management, (ii) screening and risk assessment of the target population, (iii) management of weight, and (iv) follow-up for weight sustenance. A series of online meetings with GDG were organised to prioritise and finalise the list of key clinical questions that can be addressed in this guideline document. The list of key clinical questions was peer-reviewed for its necessity in clinical practice, relevance, face, and content validity under two levels. At the first level review, key clinical questions were reviewed, modified, and finalised by a group of four to five topic-specific experts. The modified clinical questions were subjected to a second-level peer-review done by a larger group of experts, including experts from different disciplines, journal editors, and senior professors from leading organisations. Finally, 19 key clinical questions were prioritised for appropriate midlife health care. Review of evidence to answer the clinical questions To develop the recommendations, an exhaustive and systematic literature review was conducted independently for each clinical question. Search for evidence: A search string was developed for each clinical question. The keywords related to each clinical question were identified through initial literature search, recommendations from experts, and discussion amongst the evidence review team. Three electronic databases (PubMed, Wiley, and Cochrane) were searched to extract relevant evidence. Selection criteria: Studies published in peer-reviewed English-language journals and on human participants were selected. Methodological filters related to the study design were not applied at this stage to ensure an extensive and exhaustive search. The evidence team further performed the title, abstract, and full-text screening of articles. Any disagreements on selecting a manuscript were resolved by consensus among the evidence team members. Eligibility criteria: Inclusion Criteria: Existing practice guidelines, position statement, consensus statement, systematic reviews on weight management and menopausal health and randomised control trials (RCT), experimental and observational studies recruiting midlife women at different menopausal stages, i.e. perimenopause, menopause, or post-menopause were included. Exclusion Criteria: Studies reported in non-English language, published in non-peer-reviewed journals, and with limited access were excluded. Data extraction and synthesis: The following study characteristics were extracted: year of publication, country, author, study design, sample size, and sample characteristics specific to the clinical question. The findings of the studies were reported in tables to form a write-up for a summary statement. Development of clinical practice recommendations The extracted high-quality data for each clinical question was presented with a summary of evidence supplemented by a narrative table. The evidence was circulated amongst the experts for evaluation to form necessary clinical practice recommendations. Experts were given the training to develop recommendations through online meetings on the following criteria: reviewing evidence, formulating evidence-based recommendations, providing expert opinion, reaching a consensus whenever there is a lack of evidence, and grading the recommendation based on quality. This led to the development of two types of recommendations that is, Recommendations Based on Evidence (RBE) and Recommendations Based on Opinion (RBO). The developed recommendations were subjected to a two-level peer-review process. The first review was conducted by a small group of topic-specific experts, and the second review with a large group of experts, including field experts, academicians and journal editors. GRADE approach The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence profile was constructed to determine the quality of evidence obtained for clinical questions [Tables 1 and 2]. Four grades: high, moderate, low, and very low were used to rate the quality of evidence.[9]Table 1: Quality of evidenceTable 2: Grades for the strength of recommendationResults Section I: Initiation of discussion for weight management 1.1 When should a healthcare provider initiate structured counselling regarding weight management in midlife women? Background The menopausal transition is marked by the onset of irregularity in the menstrual cycle and menopausal symptoms, including hot flushes, physical decline, and emotional volatility.[2,10] In midlife, chronological ageing coupled with menopausal transition leads to several biological changes predisposing women to weight gain. The independent and interactive contribution of increasing age and menopausal transition remains debatable. Nevertheless, both these factors impact the daily lifestyle behaviours, including eating, activity, and sleep habits of midlife women in a way that might make them prone to excessive weight gain.[6] There is a need to understand at which stage during the menopausal transition should weight gain be identified as a potential detriment to the overall health and quality of life. Identifying these critical phases during midlife can help in the early initiation of weight management support by the healthcare provider. Summary of evidence In India, the mean age of initiation of the menopausal transition is 44 years, whereas 46 years is the mean age at menopause, which is lower than Caucasian women.[11] Similar findings are reported by a systematic review reporting that the age at menopause was 46.24 ± 3.38 years in Indian women.[12]Further, the mean age of early menopause due to premature ovarian insufficiency was 38 years, and late menopause was beyond 54 years. Some studies reported a positive association of menopause with an overall increase in body weight status.[13,14] However, a direct association of the overall increase in the weight status with hormonal changes during the menopausal transition could not be established. Menopause transition was related to an increase in visceral adiposity.[15,16] Women experienced a steady increase in weight and body fat during perimenopause and menopausal phases. During the menopausal transition, the accelerated gain in fat mass doubled, whereas a decline in lean muscle mass was observed. The rate of change in the body weight and fat accumulation stabilised before initiation of the post-menopausal phase.[17] Postmenopausal women with overweight and obesity have shown greater circulating estrogen levels than non-obese counterparts. This increase in estrogen is contributed by the peripheral aromatisation of the androgens in adipose tissues. It was previously hypothesised that excessive circulating estrogen levels are beneficial for maintaining menopausal and metabolic health. However, recent studies found out that the increase in estrogen levels is not associated with the protective cardiometabolic effects.[16]Discussion There is a lack of consistent literature on the independent and interactive nature of chronological ageing and menopausal transition on the weight status of menopausal women. Considering the mean age at menopause as 46 years, it is crucial to engage midlife women in weight regulation before menopausal transition.[11] Ideally, opportunistic screening and management should be delivered across the women’s lifespan (as presented in Table 1.1.1). Similarly, as per the Anklesaria staging menopausal system, at stage 1 during the perimenopausal phase, the advice should be shared to create awareness and manage obesity and other menopause-related health risks amongst midlife women.[18] In the later 30s, women should be made aware of experiencing a probable increase in their weight and total body fat status with the onset of the menopausal transition. At this phase, the healthcare providers should counsel women regarding the changes in the menstrual cycle and its probable association with weight gain. Because the age at menopause can vary amongst women belonging to different population groups, the experts have given a dual strength of recommendation to this clinical practice. In the late 40s, an opportunistic screening of weight and health status, followed by customised weight management, should be initiated and continued with the aim of achieving normal weight status. The healthcare provider should advise dietary and physical activity modifications using behavioural techniques for managing weight. In addition, other menopause-related health issues, including psychological distress, sarcopenia, and bone health, should also be addressed during weight management. It should be noted that the evidence for the recommendations mentioned above is derived mainly from studies on midlife women in the west. To our knowledge, there are no longitudinal studies that assess the changes in weight status and body composition during the menopausal transition in midlife women from India. The association of menopausal transition (independent of chronological ageing) and weight status needs to be assessed for the engagement of Indian women in weight-management practices. Thus, the recommendations should be revisited and revised every 5 to 10 years in the face of new evidence on the age of menopause in Indian women, changes in body composition during menopausal transition, and effective weight management practices.1.2: What are the components of knowledge, attitude and practice (KAP) that should be evaluated to plan a personalised weight management intervention in midlife women? Background The successful management of obesity and other lifestyle-related disorders depends on adopting behavioural techniques for correcting eating, activity, and other lifestyle-related habits.[19] The behavioural practices are motivated by pre-existing knowledge and attitude of an individual. In the literature, knowledge is defined as information and skills acquired using experience and education. Attitude is a value, belief, and feeling that predisposes an individual towards a particular behaviour and behavioural practices are habits and patterns associated with the maintenance of weight status.[20,21] KAP assessment is common in lifestyle-related diseases in clinical and community settings.[22] The clinician needs to understand the KAP of midlife women that promotes obesity. The KAP of core components associated with obesity in midlife women should include lifestyle practices, menopausal symptoms, bone health, and psychological distress.[2] Generally, the KAP can be assessed before the initiation of lifestyle management to identify the risk factors specific to middle-aged women that the clinician should attempt to modify during weight management. A few qualitative studies and cross-sectional surveys have independently assessed KAP for different obesity-related factors in midlife women.[23-25] In qualitative studies, the influence of social, cultural, and economic constructs on obesity-related behaviours has been highlighted. Across cross-sectional studies, KAP was assessed using self-developed or validated questionnaires that rate an individual’s competence in the three domains and correlate with weight and metabolic status.[26-28] A comprehensive assessment of KAP on lifestyle practices, menopausal symptoms, bone health, and psychological distress as risk factors for obesity in midlife is lacking in the current literature. Hence, this clinical question addressed the present evidence on KAP of critical components associated with the management of obesity in midlife women to deliver women-centric management of obesity. Summary of evidence The critical components evaluated for the initiation of management of obesity in midlife women included: weight and health-related measures, menopausal symptoms, bone health and psychological distress. The KAP of these components is considered necessary for customising the weight management regime for a midlife woman.[24,28-30] For weight and lifestyle-related parameters, women reported a lack of knowledge regarding corrective weight-related practices, lack of time, social eating, indulging in high-fat, sugar, and salt foods (HFSS), and reduced daily activity, led to obesity.[31,32]Four studies reported the interplay between the menopausal symptoms severity and psychological distress, leading to the consumption of energy-dense foods and limited physical activity in midlife women. The difficulty in sleeping due to hot flashes and mood disorders was associated with weight gain in midlife women.[33-35] Menopause led joint pain was the primary reason for limited participation in dedicated physical activity. Moreover, women had limited knowledge regarding age-related osteoporosis and measures that can be taken to maintain bone health such as getting a regular bone check-up, consuming foods rich in calcium, and consulting doctors for guidance on supplementation such as vitamin D and calcium for bone health.[27,30] In addition to limited knowledge, most women prioritised their roles as homemakers, working women and child care providers over their own health issues.[36,37] This self-sacrificing attitude coupled with limited support from family and friends in maintaining health-related behaviours in their day-to-day lifestyle should also be addressed for maintaining continuous and sustainable efforts for weight management and allied comorbidities.[24,36]Discussion A comprehensive assessment of KAP should be done to identify key areas that the interventionist should attempt to modify during lifestyle intervention to achieve clinically significant weight loss. The recommendations were based on well-known, lifestyle and midlife-related risk factors experienced during the menopausal transition. However, the evidence was from independent studies on a particular risk factor (e.g., diet, mental health, joint health etc.). There were no data on a comprehensive assessment of KAP related to risk factors of obesity in midlife women, which would be relevant to guide future clinical and research practice. Besides, the effectiveness of KAP in providing customised weight management advice for achieving significant weight loss should be assessed using longitudinal studies or RCTs in future research. Considering the importance of KAP in customising weight management approaches in midlife women, experts agreed that a comprehensive assessment of KAP as a component of risk assessment of obesity in midlife women should be incorporated into clinical practice (shown in Table 1.2.1). Based on available resources in the healthcare or community setting, healthcare professionals can assess KAP via history taking, group discussions and/or interview schedule with a structured questionnaire. The key questions that can be assessed in resource-constrained settings are presented in Table 1.2.2.1.3 Which healthcare providers can be involved in the management of overweight and obesity in midlife women? Background Obesity is a complex and multisystem disorder.[38]According to the international guidelines, preventive and curative obesity treatment should be delivered to individuals across the healthcare system.[39] The comprehensive treatment of obesity and allied complications requires a multicomponent and multidisciplinary approach. A multidisciplinary approach manages treatment components with the help of different healthcare professionals including a primary care physician, family physician and/or a gynaecologist with expertise in pharmacotherapy, an exercise physiologist, a dietitian, and a psychologist to provide comprehensive weight management counselling.[40] Despite the consensus on promoting multicomponent and multidisciplinary approaches amongst obesity experts, there are no specific guidelines or position statements on the operationalisation of these treatment modalities in daily clinical practice.[41] The limited application of multidisciplinary approaches can be due to limited healthcare resources such as a low doctor-to-patient ratio, time constraints, lack of auxiliary healthcare teams, and infrastructure, especially in developing countries.[42] Considering the challenges in the management of obesity in healthcare settings, it becomes essential to identify the roles and responsibilities of clinicians and allied healthcare professionals that can make multidisciplinary teams. Furthermore, these teams should be educated and trained to equip healthcare professionals to assess obesity risk, provide brief weight counselling advice, and referrals specialists at healthcare centres.[43] Summary of evidence The comprehensive management of overweight and obesity includes three key components: diet, physical activity and behavioural strategies. In 29 pertinent weight-loss trials, the treatment modalities were managed by either a multidisciplinary team, a core team of two healthcare professionals or single-handedly by a dietitian. In seven studies, a qualified dietitian provided lifestyle counselling to the participants to manage their weight.[44-46] As per 11 studies, weight management teams commonly consist of two healthcare professionals from different specialities. Out of 11 studies, nine studies opted for a team of dietitians and exercise experts such as physiotherapists, exercise physiologists, exercise specialists or personal trainers for weight management.[47-49] In three studies, lifestyle advice was coupled with behavioural techniques counselled by a team of dietitians and behaviour management experts such as psychologists, behaviour science experts or clinical health psychologists.[50-52] It was observed that dietitians are an essential component of all the core teams. Nine studies reported that a multidisciplinary team consisting of a dietitian, exercise physiologist, and behavioural therapist were a part of a comprehensive weight management program.[53-55]Discussion The effective management of weight in healthcare settings requires a multidisciplinary team. Despite the importance of multidisciplinary teams, the onus of effective preventive and curative obesity care lies on all the healthcare professionals who encounter midlife women with overweight and obesity. Often, midlife women meet primary care physicians and family physicians as the first point of contact in the healthcare system. The incorporation of family care physicians as a part of the core weight management team or an extended weight management team is vital for initiating effective management at the healthcare level. In literature, dietitians-led weight management was most commonly observed across weight-loss trials. The inclusion of dietitians in core weight management teams and/or frequent referrals to dietitians can be helpful to impart detailed lifestyle modification counselling that might not be feasible for a general practitioner or gynaecologist in a busy outpatient setting. Experts believe further attempts can be made based on the available healthcare resources to involve specialists and clinicians such as exercise physiologists, psychologists, and orthopaedics who have decisive roles in obesity management in midlife women. Considering the limited healthcare resources in developing countries such as India, a dedicated multidisciplinary approach can be limited to established tertiary healthcare set-ups. Experts suggest that interprofessional education and training sessions to discuss professional attitudes, skills and barriers faced in everyday clinical practice for obesity management can be the first step to mitigate this resource constraint. Every healthcare provider should be trained in opportunistic screening and generalised management of obesity in midlife women. 1.4: What could be the effective ways of delivering pertinent information to midlife women regarding the management of overweight and obesity? Background Health promotion counselling is a feasible, cost-effective and long-term solution for the effective management of obesity. The National Health and Medical Research Council (NHMRC) (2013) recommendations refer to the importance of health promotion and lifestyle advice to identify, assist and treat individuals with obesity.[56] The lifestyle counselling paradigm has evolved over the years from personalised counselling sessions to web-based interventions.[57,58]Personalised counselling can be defined as one-to-one counselling sessions with trained healthcare providers focused on managing an individual’s weight-related issues.[59] Group counselling provides an opportunity to discuss and share similar weight-related concerns amongst a group of participants in the presence of trained healthcare professionals in a real social setting.[60]In the current clinical practice, the traditional one-to-one counselling is supplemented with web-based interventions that help in improving compliance to the lifestyle advice by providing personalised feedback and addressing challenges in real-time.[61]Web-based counselling utilises technological components such as the internet, mobile application and online social support groups to counsel women on weight-related issues.[62] Nowadays, web-based counselling techniques have replaced the non-digital formats for nutrition education consisting of patient education material such as pamphlets, brochures, and e-newsletters. However, there is limited evidence on the mode of lifestyle counselling (independent or in combination) that will effectively manage weight in midlife women. Further, healthcare professionals need to understand the most effective and promising way of delivering information for counselling on weight management components (diet, physical activity and behaviour) for widespread acceptance of advice. To date, the role of different counselling techniques and modalities of communication in improving odds of achieving successful weight loss and prevention of weight gain remains unclear. Hence, this clinical question was undertaken to identify the most promising ways of counselling and delivery of patient education advice for effective management of obesity in clinical and community settings. Summary of evidence The pertinent studies identified used a range of counselling techniques, including personalised counselling sessions, group counselling, telephonic counselling sessions, or a combination to achieve significant weight loss. A systematic review comparing the role of group and individualised counselling for weight management reported that group counselling led by a psychologist was more effective for female participants.[63] It was also reported that in-person and more frequent contact were not associated with more significant weight loss.[64]In addition to these techniques, web-based counselling sessions were also opted for weight management. Four meta-analysis and systematic reviews assessed the role of technology-based interventions suggesting different web-based interventions were minimally effective in weight management. In comparison to traditional personalised counselling techniques, the efficacy of the web-based intervention was inconsistent.[65] A recent systematic review suggested that web-supported video conferencing sessions are effective in maintaining physical activity.[58] In addition to counselling, various forms of nutrition education material have been used across trials to facilitate weight loss. Education material such as printed material, exercise videos and mobile application for self-monitoring is available.[44,66,67] A systematic review has reported that dietary counselling was mostly given as verbal advice coupled with handouts/brochures. There were no referrals for comprehensive weight management to the dietitians. Three-fourth of the participants were advised to walk for physical activity without providing any tailor-made activity plan.[68] It was suggested that a toolkit approach should be undertaken, including evidence-based and practical dietary, physical activity, and behavioural advice.Discussion A combined counselling regime consisting of individualised and internet-based