Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial.

Background: Severe obesity during childhood is associated with cognitive deficits. Studies in adults have suggested improvements in executive functioning and memory after bariatric surgery. Our aim was to explore changes in cognitive function in adolescents over two years after bariatric surgery or intensive non-surgical treatment. Methods: The Adolescent Morbid Obesity Surgery 2 (AMOS2) is a multicentre, open-label, randomised controlled trial in which adolescents (aged 13-16 years) with severe obesity (defined as body mass index (BMI) ≥35 kg/m2) at three specialised obesity centres in Sweden, were randomly assigned to receive bariatric surgery or intensive non-surgical treatment. Herein we report the results of the prespecified exploratory endpoint of change in cognitive functioning. Inclusion in AMOS2 required Tanner pubertal stage ≥3, previous participation in lifestyle obesity treatment for at least one year, and passed assessment form a paediatrician and a paediatric psychologist. Adolescents with severe intellectual disability or other severe, pervasive developmental disorder were excluded. Participants underwent baseline assessment of general intellectual ability, executive functioning, and memory before randomisation. Tests were administrated by clinical psychologists and repeated at one- and two-year follow-up timepoints. Differences in means between groups during follow-up are provided with confidence intervals. The trial is registered at ClinicalTrials.gov, NCT02378259. Findings: Between October 28 2015 and June 7 2017, 46 adolescents (74% girls), with a mean age of 15.8 (±0.92) years and a mean BMI of 42.8 (±5.4) kg/m2, were included and randomised (23 to bariatric surgery and 23 to intensive non-surgical treatment). At baseline 23/46 (50%) of the adolescents had general intellectual functioning classified as borderline or below. For 15/18 (83%) aspects of cognitive functioning, no significant differences in change over two years were identified between groups; Immediate (average difference during follow-up 1.0 [95% CI: -2.6 to 4.6]) and Delayed (0.5 [95% CI: -0.6 to 1.6]) Verbal Recall, Category Fluency (1.1 [95% CI: -1.6 to 3.8]) and Switching (1.5 [95% CI: -0.0 to 2.9]), Number (-6.0 [95% CI: -12.3 to 0.3]) and Letter (0.1 [95% CI: -5.2 to 5.3]) Sequencing, Number-Letter Switching (-10.3 [95% CI: -26.4 to 5.8]), Motor Speed (-8.3 [95% CI: -17.5 to 0.9]), Colour Naming (-1.9 [95% CI: -4.2 to 0.3]), Inhibition (-3.6 [95% CI: -9.6 to 2.5]), Inhibition Switching (-6.7 [95% CI: -15.3 to 1.9]), Mazes (-0.5 [95% CI: -4.9 to 3.9]), Digit Span Forward (0.1 [95% CI: -0.6 to 0.9 ]) and Backward (0.6 [95% CI: -0.4 to 1.6 ]), and Estimated IQ (0.4 [95% CI: -3.9 to 4.8]; all p > 0.05). Three sub-tests assessing fundamental cognitive skills improved more over two years in operated adolescents than in intensive non-surgical treatment; Letter Fluency (average difference during follow-up 3.8 [95% CI: 0.1-7.5]; p = 0.046), Visual Scanning (-6.5 [95% CI: -11.6 to -1.5]; p = 0.011), and Word Reading (-1.9 [95% CI: -3.3 to -0.4]; p = 0.011). Interpretation: In contrast to non-randomised studies in adults, we could not demonstrate an association of bariatric surgery and its accompanying significant weight loss with overall greater improvement in executive functions and memory in adolescents over two years compared with a non-surgical group without weight loss. However, lack of statistical power is a potential limitation. The clinical relevance of greater improvements in basic cognitive skills needs to be explored. Funding: Sweden's innovation agency (VINNOVA), Swedish Research Council, Joanna Cocozza foundation for paediatric research, The Skane University Hospital Psychology Research and Development Grant, Tore Nilsson's Foundation, SUS Foundations and Donations, and Mary von Sydow's Foundation.

Significant effects of childhood obesity treatment with a web-based component in a randomised controlled study (Web-COP).

AIM: We evaluated the effect on body mass index standard deviation score (BMI-SDS) of a combined treatment (Web-COP) for children with obesity, including a web-based component targeting their parents. METHODS: This randomised controlled trial recruited children 5-12 years of age with obesity (International Obesity Task Force BMI [IOTF-BMI] ≥30 kg/m2 ) from school health care and outpatient paediatric clinics in in Northern Sweden from 1 June 2019 to 21 June 2020. The children were randomised to Web-COP, an intervention with group sessions and a 12-week web-based component, or standard care. The primary outcome was the change in IOTF BMI-SDS after 6 months. RESULTS: In total, 75 children (33 girls), mean age 9.5 years, were randomised, and 65/75 (87%) children and their parents completed the study, 35/39 (90%) in the Web-COP intervention and 30/36 (83%) in the standard care group. BMI-SDS at 6 months was changed from 3.08 to 2.81 in the intervention group compared to an increase from 3.07 to 3.16 in the standard care group, representing a significant difference between groups (p < 0.001). In the intervention group, 14/30 (47%) reduced their BMI-SDS ≥0.25, compared to none in the standard care group. CONCLUSION: The parent-focused intervention significantly improved BMI-SDS in children with obesity as compared to children in standard care.

Long-term Outcomes Following Adolescent Metabolic and Bariatric Surgery.

Severe obesity in adolescence negatively impacts upon health and wellbeing. Lifestyle modifications do not usually achieve a sufficient degree or durability of weight loss to mitigate the risk of medical complications. In recent years, metabolic and bariatric surgery (MBS), already a well-established treatment for adults with severe obesity, has emerged as an option in adolescents. Controlled studies in this age group have demonstrated substantial and sustained weight loss, improvements in associated health parameters, and a safety profile surpassing that observed in adult patients. This review aims to present published data on the results of MBS in adolescents with a focus on long-term outcomes. Indications for bariatric surgery and aspects of timing in the young person's life are also presented, along with safety considerations and factors influencing patient selection for surgery. We conclude, predominantly from short- to medium-term outcomes data, that MBS is a safe and valuable therapeutic option for adolescents with severe obesity. Considering the poor health and social wellbeing prognosis in this group, MBS appears to be underutilized. The need for continued research, multiprofessional specialist provision, coherent contemporary clinical guidelines, and routine long-term follow-up in adolescents undergoing MBS is highlighted.

Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden.

BACKGROUND: Severe obesity in adolescents has a profound impact on current and future health. Metabolic and bariatric surgery (MBS) is increasingly used in adolescents internationally. However, to our knowledge, there are no randomised trials examining the currently most used surgical techniques. Our aim was to evaluate changes in BMI and secondary health and safety outcomes after MBS. METHODS: The Adolescent Morbid Obesity Surgery 2 (AMOS2) study is a randomised, open-label, multicentre trial done at three university hospitals in Sweden (located in Stockholm, Gothenburg, and Malmö). Adolescents aged 13-16 years with a BMI of at least 35 kg/m2, who had attended treatment for obesity for at least 1 year, passed assessments from a paediatric psychologist and a paediatrician, and had a Tanner pubertal stage of at least 3, were randomly assigned (1:1) to MBS or intensive non-surgical treatment. Exclusion criteria included monogenic or syndromic obesity, major psychiatric illness, and regular self-induced vomiting. Computerised randomisation was stratified for sex and recruitment site. Allocation was concealed for both staff and participants until the end of the inclusion day, and then all participants were unmasked to treatment intervention. One group underwent MBS (primarily gastric bypass), while the other group received intensive non-surgical treatment starting with 8 weeks of low-calorie diet. The primary outcome was 2-year change in BMI, analysed as intention-to-treat. The trial is registered at ClinicalTrials.gov, NCT02378259. FINDINGS: 500 people were assessed for eligibility between Aug 27, 2014, and June 7, 2017. 450 participants were excluded (397 did not meet inclusion criteria, 39 declined to participate, and 14 were excluded for various other reasons). Of the 50 remaining participants, 25 (19 females and six males) were randomly assigned to receive MBS and 25 (18 females and seven males) were assigned to intensive non-surgical treatment. Three participants (6%; one in the MBS group and two in the intensive non-surgical treatment group) did not participate in the 2-year follow-up, and in total 47 (94%) participants were assessed for the primary endpoint. Mean age of participants was 15·8 years (SD 0·9) and mean BMI at baseline was 42·6 kg/m2 (SD 5·2). After 2 years, BMI change was -12·6 kg/m2 (-35·9 kg; n=24) among adolescents undergoing MBS (Roux-en-Y gastric bypass [n=23], sleeve gastrectomy [n=2]) and -0·2 kg/m2 (0·4 kg; [n=23]) among participants in the intensive non-surgical treatment group (mean difference -12·4 kg/m2 [95% CI -15·5 to -9·3]; p<0·0001). Five (20%) patients in the intensive non-surgical group crossed over to MBS during the second year. Adverse events (n=4) after MBS were mild but included one cholecystectomy. Regarding safety outcomes, surgical patients had a reduction in bone mineral density, while controls were unchanged after 2 years (z-score change mean difference -0·9 [95% CI -1·2 to -0·6]). There were no significant differences between the groups in vitamin and mineral levels, gastrointestinal symptoms (except less reflux in the surgical group), or in mental health at the 2-year follow-up. INTERPRETATION: MBS is an effective and well tolerated treatment for adolescents with severe obesity resulting in substantial weight loss and improvements in several aspects of metabolic health and physical quality of life over 2 years, and should be considered in adolescents with severe obesity. FUNDING: Sweden's Innovation Agency, Swedish Research Council Health.

Metabolic and Bariatric Surgery in Adolescents: For Whom, When, and How?

Severe obesity in adolescence profoundly impacts health and social well-being. Lifestyle modifications are seldom successful in maintaining sufficient weight loss to mitigate the risk of complications. Metabolic and bariatric surgery (MBS) is a standard treatment for adult patients and has emerged as an option for adolescent patients. Several high-quality studies of adolescent MBS show substantial and sustained improvements both in weight and cardiometabolic parameters, as well as a safety profile similar to that seen in adult patients. Patients report improvements in health- and weight-related quality of life. Concerns around adolescent MBS can be attributed to a fear of side effects on growth and puberty, risk of nutritional deficiencies and osteoporosis, alcohol abuse, psychosocial vulnerability, and the ability to consent in the decision process. Guidelines give somewhat different recommendations, but the most comprehensive guidelines from the American Society for Metabolic and Bariatric Surgery recommend MBS for class III obesity or class II obesity with comorbidity. This mini-review aimed to pre-sent published data on MBS in adolescents. We discuss indications for MBS and the optimal timing in the young person's life, the choice of surgical method, and MBS in relation to the new anti-obesity medications. Based on data primarily from the USA and Sweden, we conclude that MBS is a valuable treatment option for adolescents with severe obesity that appears underutilized against the backdrop of the poor prognosis of severe obesity. We argue for continued research, development of guidelines, multi-professional teamwork, long-term follow-up, and centralization of adolescent MBS.

Exploring data quality and use of the routine health information system in Ethiopia: a mixed-methods study.

OBJECTIVE: A routine health information system (RHIS) enables decision making in the healthcare system. We aimed to analyse data quality at the district and regional level and explore factors and perceptions affecting the quality and use of routine data. DESIGN: This was a mixed-methods study. We used the WHO toolkit for analysing data quality and interviewed staff at the point of data generation and along with the flow of data. Data were analysed using the Performance of Routine Information System Management framework. SETTING: This study was performed in eight districts in four regions of Ethiopia. The study was nested within a 2-year programme of the Operational Research and Coaching for government Analysts. PARTICIPANTS: We visited 45 health posts, 1 district hospital, 16 health centres and 8 district offices for analysis of routine RHIS data and interviewed 117 staff members for the qualitative assessment. OUTCOME MEASURES: We assessed availability of source documents, completeness, timeliness and accuracy of reporting of routine data, and explored data quality and use perceptions. RESULTS: There was variable quality of both indicator and data element. Data on maternal health and immunisation were of higher quality than data on child nutrition. Issues ranged from simple organisational factors, such as availability of register books, to intricate technical issues, like complexity of indicators and choice of denominators based on population estimates. Respondents showed knowledge of the reporting procedures, but also demonstrated limited skills, lack of supportive supervision and reporting to please the next level. We saw limited examples of the use of data by the staff who were responsible for data reporting. CONCLUSION: We identified important organisational, technical, behavioural and process factors that need further attention to improve the quality and use of RHIS data in Ethiopia.

Adapting pediatric obesity care to better suit adolescent patients: Design of a treatment platform and results compared with standard care in the national patient quality register.

BACKGROUND: Obesity constitutes a critical risk for adolescent health. This study aimed at identifying youth-friendly components of obesity treatment. METHODS: In this feasibility study, an adolescent obesity treatment platform was implemented at two Pediatric outpatient clinics in Sweden. Body mass index (BMI), BMI z-score, and the category of obesity (International Obesity Task Force) were compared before and after the intervention and with data on standard care from the Swedish Childhood Obesity Treatment Register. RESULTS: The study included 99 participants (49 females) aged 13-18 years from 1 September 2014, to 31 December 2016. A pediatric nurse met the participants on average 6.5 times in the average inclusion period of 15 months. Physical activity sessions attracted 63 participants. Acceptance Commitment Therapy and In Real Life groups attracted 24 participants. At inclusion, 62 participants had obesity and 37 severe obesity, and 71/99 (72%) remained in the same category. The mean BMI increased from 32.0 to 33.4 kg/m2 (p < 0.01), but 56/94 (60%) participants lowered their BMI or increased less than 1 kg/m2 and 73% stayed to the end of the study. Participants who were new to treatment and participants coming for more than eight visits to the nurse did not increase in BMI. BMI did not change for the 221 out of 641 register patients who had two recordings of BMI in the study period. CONCLUSIONS: The platform was successful in increasing retention, and 60% of participants lowered or maintained their BMI. Still, seven out of ten adolescents with obesity or severe obesity remained in the same weight category.

The Association of Low Blood Glucose and Low Serum Cortisol Levels in Severely Ill Children Admitted to Tertiary Referral Hospitals in Malawi: A Case-Control Study.

Low blood glucose concentrations < 5 mmol/L in severely ill children presenting to hospitals in low-income countries are associated with mortality. Adrenal insufficiency with low cortisol levels may contribute to low blood glucose concentrations. Understanding the association between low cortisol and low blood glucose may assist in improving guidelines for management of severely ill children. The study aimed to determine the association between low serum cortisol and low blood glucose in severely ill children. A matched case-control study of children aged 1 month to 15 years was conducted at two tertiary hospitals in Malawi. Cases were children with blood glucose < 5 mmol/L. Two age-matched controls with blood glucose of ≥ 5-15 mmol/L were enrolled per case. Low cortisol was defined as serum cortisol of < 25 µg/dL (690 nmol/L) and adrenal insufficiency as serum cortisol of < 10 µg/dL (276 nmol/L). A total of 54 cases and 108 controls were enrolled with, median age of 2.8 years (interquartile range [IQR]: 1.7-4.4). The median cortisol level was 58.7 µg/dL (IQR: 42.3-61.8) in cases and 40.9 µg/dL (IQR: 33.7-51.2) in controls (P = 0.911). The proportion of low cortisol was 4/54 (7.4%) in cases and 9/108 (8.3%) in controls. Logistic regression shows no association between low cortisol and low blood glucose (adjusted odds ratio: 0.33; 95% confidence interval, 0.04-3.02). Results suggest that there is no association between low cortisol and low blood glucose among severely ill children presenting to hospitals in Malawi. The reason for low blood glucose needs further investigation.

Strengthening routine health data analysis in Ethiopia: the Operational Research and Coaching for Analysts (ORCA) experience.

Many routine health information systems (RHIS) show persistent gaps between recording and reporting data and their effective use in solving problems. Strengthening RHIS has become a global priority to track and address national health goals. In Ethiopia, the Ministry of Health and Bill & Melinda Gates Foundation introduced the Operational Research and Coaching for Analysts (ORCA) capacity development project, co-designed with the London School of Hygiene & Tropical Medicine, which delivered training, coaching and mentoring support. We present the development, experiences, and perceptions of ORCA as a mechanism to enhance data quality, analysis, interpretation and use. ORCA integrated capacity development activities into national data analysts' routine workload over a period of 2 years. Participating analysts were drawn from across the Ministry of Health directorates and two of its closely aligned agencies: the Ethiopian Public Health Institute and the Ethiopian Pharmaceutical Supply Agency. We used mixed methods (knowledge questionnaire, semi-structured interviews, programme records) to document the fidelity, feasibility, reach, and acceptability of ORCA and identify early signs of improved knowledge and changing institutional practices. Thirty-six participants completed the programme. Working in interdisciplinary groups on specific national health indicators, they received training workshops and support for study design, fieldwork, and analysis to build skills in assessing data quality and interpreting findings relevant to policy. Personal development grants and laptops provided incentives for sustained engagement. Participants appreciated ORCA's applied and practical approach as well as good communication from administrators and clear links to national strategy. They also expressed frustration with delays, difficulties prioritising project work over routine responsibilities, and lack of formal accreditation. Knowledge and analytic skills increased and participants were able to integrate experiences from the project into their future work. Health system managers saw potential in longer-term improvements in data analysis and application to policy, although no clear changes were observed yet.

'Now she prefers jeans, like everyone else ' - Parents' experiences of group- and web-based treatment of children's obesity.

AIM: Web-based interventions have shown promising results in paediatric obesity treatment with the potential to increase coverage of care. This study aimed to explore parental experiences about participating in an intervention to improve healthy behaviours and lower BMI-SDS in children with obesity. METHODS: This was an interview study with an inductive qualitative approach. Data were collected from individual interviews with 14 parents of 5- to 13-year-old children with obesity. The respondents had participated in a family-based treatment intervention consisting of four group sessions followed by 12-week web-based support. The interviews were analysed using qualitative manifest and latent content. RESULTS: The overarching theme 'A transformative journey of lifestyle changes for the whole family' described how the participation impacted the lifestyle of the whole family. Four categories: parental awareness, introducing new routines, negotiating family battles and a feeling of support, represented various experiences made by respondents. The parents shared predominantly positive experiences of the intervention but also expressed feelings of guilt and struggled to address their child's obesity. CONCLUSION: Parents who participated in a study for children with obesity with a web-based component found the programme helpful for achieving healthier lifestyles for the whole family.

Routine health management information system data in Ethiopia: consistency, trends, and challenges.

Background: Ethiopia is investing in the routine Health Management Information System. Improved routine data are needed for decision-making in the health sector. Objective: To analyse the quality of the routine Health Management Information System data and triangulate with other sources, such as the Demographic and Health Surveys. Methods: We analysed national Health Management Information System data on 19 indicators of maternal health, neonatal survival, immunization, child nutrition, malaria, and tuberculosis over the 2012-2018 time period. The analyses were conducted by 38 analysts from the Ministry of Health, Ethiopia, and two government agencies who participated in the Operational Research and Coaching for Analysts (ORCA) project between June 2018 and June 2020. Using a World Health Organization Data Quality Review toolkit, we assessed indicator definitions, completeness, internal consistency over time and between related indicators, and external consistency compared with other data sources. Results: Several services reported coverage of above 100%. For many indicators, denominators were based on poor-quality population data estimates. Data on individual vaccinations had relatively good internal consistency. In contrast, there was low external consistency for data on fully vaccinated children, with the routine Health Management Information System showing 89% coverage but the Demographic and Health Survey estimate at 39%. Maternal health indicators displayed increasing coverage over time. Indicators on child nutrition, malaria, and tuberculosis were less consistent. Data on neonatal mortality were incomplete and operationalised as mortality on day 0-6. Our comparisons with survey and population projections indicated that one in eight early neonatal deaths were reported in the routine Health Management Information System. Data quality varied between regions. Conclusions: The quality of routine data gathered in the health system needs further attention. We suggest regular triangulation with data from other sources. We recommend addressing the denominator issues, reducing the complexity of indicators, and aligning indicators to international definitions.

High prevalence of neurodevelopmental problems in adolescents eligible for bariatric surgery for severe obesity.

AIM: To assess the prevalence of neurodevelopmental problems in adolescents with severe obesity and their associations with binge eating and depression. METHODS: Data were collected at inclusion in a randomised study of bariatric surgery in 48 adolescents (73% girls; mean age 15.7 ± 1.0 years; mean body mass index 42.6 ± 5.2 kg/m2 ). Parents completed questionnaires assessing their adolescents' symptoms of attention-deficit/hyperactivity disorder and autism spectrum disorder and reported earlier diagnoses. Patients answered self-report questionnaires on binge eating and depressive symptoms. RESULTS: The parents of 26/48 adolescents (54%) reported scores above cut-off for symptoms of the targeted disorders in their adolescents, but only 15% reported a diagnosis, 32% of adolescents reported binge eating, and 20% reported symptoms of clinical depression. No significant associations were found between neurodevelopmental problems and binge eating or depressive symptoms. Only a third of the adolescents reported no problems in either area. CONCLUSION: Two thirds of adolescents seeking surgical weight loss presented with substantial mental health problems (reported by themselves or their parents). This illustrates the importance of a multi-professional approach and the need to screen for and treat mental health disorders in adolescents with obesity.

Improving quality and use of routine health information system data in low- and middle-income countries: A scoping review.

BACKGROUND: A routine health information system is one of the essential components of a health system. Interventions to improve routine health information system data quality and use for decision-making in low- and middle-income countries differ in design, methods, and scope. There have been limited efforts to synthesise the knowledge across the currently available intervention studies. Thus, this scoping review synthesised published results from interventions that aimed at improving data quality and use in routine health information systems in low- and middle-income countries. METHOD: We included articles on intervention studies that aimed to improve data quality and use within routine health information systems in low- and middle-income countries, published in English from January 2008 to February 2020. We searched the literature in the databases Medline/PubMed, Web of Science, Embase, and Global Health. After a meticulous screening, we identified 20 articles on data quality and 16 on data use. We prepared and presented the results as a narrative. RESULTS: Most of the studies were from Sub-Saharan Africa and designed as case studies. Interventions enhancing the quality of data targeted health facilities and staff within districts, and district health managers for improved data use. Combinations of technology enhancement along with capacity building activities, and data quality assessment and feedback system were found useful in improving data quality. Interventions facilitating data availability combined with technology enhancement increased the use of data for planning. CONCLUSION: The studies in this scoping review showed that a combination of interventions, addressing both behavioural and technical factors, improved data quality and use. Interventions addressing organisational factors were non-existent, but these factors were reported to pose challenges to the implementation and performance of reported interventions.

Development, implementation and early results of a 12-week web-based intervention targeting 51 children age 5-13 years and their families.

BACKGROUND: Internet-based treatments have proven effective for various health issues. There is a need to scale up interventions targeting children with obesity, also in less densely populated areas where the prevalence in many countries is higher than in urban areas. The aim of this study was to design and implement an internet-based program as an add-on to standard treatment for childhood obesity. METHODS: Web-Childhood Obesity Prevention (Web-COP) was a prospective feasibility study with a pre- post- design. The intervention consisted of four group-based education sessions at the clinic, physical activity on prescription, and a new 12-week internet-based program. Web-COP was offered to children with obesity (International Obesity Task Force Body Mass Index (IOTF-BMI) ≥ 30 kg/m2) and their parents in two counties in Northern Sweden from August 2018 to June 2019. The primary outcome was change in BMI standard deviation score (BMI-SDS). RESULTS: The study included 55 children 5-13 years of age. The internet-based component was well received, and retention rate was 51/55 (92.7%). Data was analysed for 51 children. Mean BMI-SDS was 3.3 at start and decreased by 0.2, 0.3, and 0.4 at two, four, and six months from baseline. Using a continuous algorithm, 42/51 (81%), children lowered their BMI-SDS and 33/51 (65%) lowered their BMI. CONCLUSION: Adding group sessions and an internet-based program to standard care was feasible and two thirds of included children with obesity reduced their BMI.