Effectiveness of a complex intervention of group-based nutrition and physical activity to prevent frailty in pre-frail older adults (SUPER): a randomised controlled trial.

BACKGROUND: The increasing prevalence of frailty with age is becoming a public health priority in countries with ageing populations. Pre-frailty presents a window of opportunity to prevent the development of frailty in community-dwelling older adults. This study aimed to examine the effectiveness of a complex intervention that combined a nutrition-based intervention and a physical activity intervention, along with the effectiveness of each intervention individually, to reduce physical frailty in pre-frail older adults over 2 years. METHODS: In this single-blind, 2 x 2 factorial, randomised, controlled trial, we recruited pre-frail community-dwelling older adults in Aotearoa New Zealand via mail through general medical practices. To be eligible, participants had to be pre-frail according to self-reported FRAIL scores of 1 or 2, aged 75 years or older (or 60 years or older for Maori and Pacific Peoples), not terminally ill or with advanced dementia as judged by a general practitioner, able to stand, medically safe to participate in low-intensity exercise, and able to use kitchen utensils safely. Participants were randomly allocated to receive an 8-week Senior Chef programme (SC group), a 10-week Steady As You Go programme (SAYGO group), a 10-week combined SC and SAYGO intervention (combined group), or a 10-week social programme (control group), using computer-generated block randomisation administered through an electronic data capture system by local study coordinators. Assessors were masked to group allocation for all assessments. SC is a group-based nutrition education and cooking class programme (3 h weekly), SAYGO is a group-based strength and balance exercise programme (1 h weekly), and the social control programme was a seated, group socialising activity (once a week). Masked assessors ascertained Fried frailty scores at baseline, end of intervention, and at 6, 12, and 24 months after the programme. The primary outcome was change in Fried frailty score at 2 years. Intention-to-treat analyses were completed for all randomised participants, and all participants who had a high (≥75%) adherence were analysed per protocol. This study is registered at ANZCTR, ACTRN12614000827639. FINDINGS: Between May 12, 2016 and April 9, 2018, we assessed 2678 older adults for eligibility, of whom 468 (17%) consented and completed baseline assessment, with a mean age of 80·3 years (SD 5·1) and a mean Fried score of 1·9 (1·2); 59% were women. We randomly allocated these participants into the four groups: 117 in the SC group, 118 in the SAYGO group, 118 in the combined group, and 115 in the control group; 318 participants attended the 24-month follow-up: 89 in the SC group, 78 in the SAYGO group, 73 in the combined group, and 78 in the control group. At the 24-month follow-up, there were no differences in mean Fried scores between the intervention groups and the control group. No adverse events were reported. INTERPRETATION: The study did not find that the combined SC and SAYGO programme was effective in reducing frailty in pre-frail older adults. Although some short-term benefits were observed in each individual programme, there was no clear evidence of long-term impact. Further research is needed to evaluate combinations of group-based programmes for community-dwelling older adults to optimise their physical function. FUNDING: Health Research Council New Zealand and Ageing Well Challenge (Ministry of Business Innovation and Employment).

An index measuring adherence to New Zealand Infant Feeding Guidelines has convergent validity with maternal socio-demographic and health behaviours and with children's body size.

Using data from a nationally generalisable birth cohort, we aimed to: (i) describe the cohort's adherence to national evidence-based dietary guidelines using an Infant Feeding Index (IFI) and (ii) assess the IFI's convergent construct validity, by exploring associations with antenatal maternal socio-demographic and health behaviours and with child overweight/obesity and central adiposity at age 54 months. Data were from the Growing Up in New Zealand cohort (n 6343). The IFI scores ranged from zero to twelve points, with twelve representing full adherence to the guidelines. Overweight/obesity was defined by BMI-for-age (based on the WHO Growth Standards). Central adiposity was defined as waist-to-height ratio > 90th percentile. Associations were tested using multiple linear regression and Poisson regression with robust variance (risk ratios, 95 % CI). Mean IFI score was 8·2 (sd 2·1). Maternal characteristics explained 29·1 % of variation in the IFI score. Maternal age, education and smoking had the strongest independent relationships with IFI scores. Compared with children in the highest IFI tertile, girls in the lowest and middle tertiles were more likely to be overweight/obese (1·46, 1·03, 2·06 and 1·56, 1·09, 2·23, respectively) and boys in the lowest tertile were more likely to have central adiposity (1·53, 1·02, 2·30) at age 54 months. Most infants fell short of meeting national Infant Feeding Guidelines. The associations between IFI score and maternal characteristics, and children's overweight/obesity/central adiposity, were in the expected directions and confirm the IFI's convergent construct validity.

A prediction model for childhood obesity in New Zealand.

Several early childhood obesity prediction models have been developed, but none for New Zealand's diverse population. We aimed to develop and validate a model for predicting obesity in 4-5-year-old New Zealand children, using parental and infant data from the Growing Up in New Zealand (GUiNZ) cohort. Obesity was defined as body mass index (BMI) for age and sex ≥ 95th percentile. Data on GUiNZ children were used for derivation (n = 1731) and internal validation (n = 713). External validation was performed using data from the Prevention of Overweight in Infancy Study (POI, n = 383) and Pacific Islands Families Study (PIF, n = 135) cohorts. The final model included: birth weight, maternal smoking during pregnancy, maternal pre-pregnancy BMI, paternal BMI, and infant weight gain. Discrimination accuracy was adequate [AUROC = 0.74 (0.71-0.77)], remained so when validated internally [AUROC = 0.73 (0.68-0.78)] and externally on PIF [AUROC = 0.74 [0.66-0.82)] and POI [AUROC = 0.80 (0.71-0.90)]. Positive predictive values were variable but low across the risk threshold range (GUiNZ derivation 19-54%; GUiNZ validation 19-48%; and POI 8-24%), although more consistent in the PIF cohort (52-61%), all indicating high rates of false positives. Although this early childhood obesity prediction model could inform early obesity prevention, high rates of false positives might create unwarranted anxiety for families.

A Randomised Trial of Text Message Support for Reducing Weight Regain Following Sleeve Gastrectomy.

INTRODUCTION: Sleeve gastrectomy (SG) is a common bariatric procedure with high rates of weight regain (WR). Clinicians and patients have identified a lack of follow-up support and maladaptive lifestyle behaviours as potential causes for WR. While text message support has been shown to be effective for weight loss in non-surgical patients, it has not been investigated for reducing WR in bariatric patients. PURPOSE: To determine the effectiveness of text message support in reducing weight regain following sleeve gastrectomy. METHODS: A text message intervention was designed. The effectiveness of the intervention was investigated by a randomised trial powered to detect a 15% difference in the primary outcome of percent excess weight loss (84 participants required). Secondary outcomes were the Bariatric Analysis and Reporting System (BAROS) score and patient satisfaction. Outcomes were assessed at 6 and 12 months. RESULTS: Ninety-five participants were randomised to either standard care or text message support (daily text message for 1 year). While there was no significant difference in the primary outcome at 6 or 12 months, patients who received the intervention tended to have less WR and a significantly better BAROS score at 12 months. Participants who received text message support found it beneficial, would have liked the messages to continue, and felt WR was reduced by having the text message support. CONCLUSION: Text message support following SG is feasible, may reduce weight regain, improves the BAROS score and is valued by patients. TRIAL REGISTRATION: NCT02341001.

Patterns of multi-morbidity and prediction of hospitalisation and all-cause mortality in advanced age.

Background: multi-morbidity is associated with poor outcomes and increased healthcare utilisation. We aim to identify multi-morbidity patterns and associations with potentially inappropriate prescribing (PIP), subsequent hospitalisation and mortality in octogenarians. Methods: life and Living in Advanced Age; a Cohort Study in New Zealand (LiLACS NZ) examined health outcomes of 421 Maori (indigenous to New Zealand), aged 80-90 and 516 non-Maori, aged 85 years in 2010. Presence of 14 chronic conditions was ascertained from self-report, general practice and hospitalisation records and physical assessments. Agglomerative hierarchical cluster analysis identified clusters of participants with co-existing conditions. Multivariate regression models examined the associations between clusters and PIP, 48-month hospitalisations and mortality. Results: six clusters were identified for Maori and non-Maori, respectively. The associations between clusters and outcomes differed between Maori and non-Maori. In Maori, those in the complex multi-morbidity cluster had the highest prevalence of inappropriately prescribed medications and in cluster 'diabetes' (20% of sample) had higher risk of hospitalisation and mortality at 48-month follow-up. In non-Maori, those in the 'depression-arthritis' (17% of the sample) cluster had both highest prevalence of inappropriate medications and risk of hospitalisation and mortality. Conclusions: in octogenarians, hospitalisation and mortality are better predicted by profiles of clusters of conditions rather than the presence or absence of a specific condition. Further research is required to determine if the cluster approach can be used to target patients to optimise resource allocation and improve outcomes.

Inequity in timing of prenatal screening in New Zealand: Who are our most vulnerable?

BACKGROUND: In New Zealand (NZ), Maori and Pacific women are less likely to complete prenatal screening for Down syndrome and other aneuploidies than other ethnic groups. Young women <20 have low rates of completed screening compared with women >20 years. Women living in deprived areas have lower completed screen rates than women living in more affluent areas. Combined first trimester screening has a superior sensitivity (85%) compared with second trimester screening (75%) for trisomy 21. The relative contribution of demographic factors to timing of screening uptake (first vs second trimester) has not previously been examined. AIM: To evaluate the association of ethnicity, deprivation, District Health Board (DHB) of domicile and maternal age with timing of prenatal screening (first vs second trimester) in pregnant women screened in NZ from 2010 to 2013. METHODS AND MATERIALS: Univariate logistic regression analyses were used to explore the association between timing of completed screening and each of ethnicity, deprivation index, DHB of domicile and maternal age. Multivariate logistic regression models were developed to calculate odds ratios (OR) and 95% confidence intervals (CI). Statistical analyses were performed using SAS v9.3 RESULTS: Of completed prenatal screens, 88% were completed in the first trimester. Ethnicity, age, deprivation and DHB were all significant predictors of completed first versus second trimester screening. Maori women were almost 60% less likely (adjusted OR 0.37, CI 0.35-0.39) and Pacific women almost 80% less likely (adjusted OR 0.23, CI 0.21-0.24) than NZ European women to have completed first versus second trimester screening. Women <30 years were less likely to have completed first trimester screening, as were more deprived women. Variation was also seen by DHB with women living in Whanganui DHB less likely to have completed first versus second trimester screening than women living in Auckland (adjusted OR 0.76, CI 0.71-0.81). Women living in Bay of Plenty DHB were more likely to be screened in the first versus second trimester compared with women living in Auckland (adjusted OR 1.55, CI 1.38-1.74). Within Auckland itself, women living in Counties Manukau DHB were less likely to be screened in the first versus second trimester than women living in Auckland DHB even after adjusting for ethnicity, deprivation and maternal age. CONCLUSION: Maori and Pacific women have the lowest uptake of completed first versus second trimester screening after adjusting for age, deprivation and DHB. Research is required to understand if this relates to characteristics of the carer making the offer of screening, language and/or cultural barriers to care or specific collective cultural or religious views held by women from these ethnicities. The lower completed first trimester versus second trimester prenatal screening in deprived areas, as well as variation by DHB, may relate to the availability of ultrasound and/or laboratory services in specific regions. Cost may be a contributing factor to inequity in timing of completed prenatal screening uptake, as first trimester screening incurs a part-charge to the individual, while second trimester screening is fully funded. Systemic factors within the NZ maternity model of care may also be contributory with a potential disconnect occurring for the woman between primary medical care and later registration with a Lead Maternity Carer in the first trimester.

Adherence to adjuvant endocrine therapy: is it a factor for ethnic differences in breast cancer outcomes in New Zealand?

PURPOSE: Despite the benefits of adjuvant endocrine therapy for hormone receptor positive breast cancer, many women are non-adherent or discontinue endocrine treatment early. We studied differences in adherence to adjuvant endocrine therapy by ethnicity in a cohort of New Zealand women with breast cancer and its impact on breast cancer outcomes. METHODS: We analysed data on women (n = 1149) with newly diagnosed hormone receptor positive, non-metastatic, invasive breast cancer who were treated with adjuvant endocrine therapy in the Waikato during 2005-2011. Linked data from the Waikato Breast Cancer Registry and National Pharmaceutical Database were examined to identify differences by ethnicity in adherence to adjuvant endocrine therapy and the effect of sub-optimal adherence on cancer recurrence and mortality. RESULTS: Overall, a high level of adherence of ≥80% was observed among 70.4% of women, which declined from 76.8% to 59.3% from the first to fifth year of treatment. Maori women were significantly more likely to be sub-optimally adherent (<80%) compared with European women (crude rate 37% vs. 28%, p = 0.005, adjusted OR = 1.51, 95% CI 1.04-2.17). Sub-optimal adherence was associated with a significantly higher risk of breast cancer mortality (HR = 1.77, 95% CI 1.05-2.99) and recurrence (HR = 2.14, 95% CI 1.46-3.14). CONCLUSIONS: Sub-optimal adherence to adjuvant endocrine therapy was a likely contributor for breast cancer mortality inequity between Maori and European women, and highlights the need for future research to identify effective ways to increase adherence in Maori women.

Recruiting equal numbers of indigenous and non-indigenous participants to a 'polypill' randomized trial.

INTRODUCTION: Maori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Maori and non-Maori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a "polypill") improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Maori as non-Maori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this. METHODS: Experienced Maori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Maori researchers and was committed to equal recruitment of Maori and non-Maori. Additional funding and Maori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Maori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Maori were targeted, with over-sampling of potentially eligible Maori patients, lower thresholds for screening of Maori and 6 months continued Maori recruitment after non-Maori recruitment had finished. RESULTS: A total of 257 Maori and 256 non-Maori participants were randomized. Four Maori and eight non-Maori participants were randomized per research nurse per month. Potentially eligible Maori were more likely than non-Maori to proceed to subsequent stages of recruitment. Differences between randomized Maori and non-Maori were evident (e.g. Maori were less likely to have established coronary artery disease). CONCLUSIONS: Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

Acetaminophen (paracetamol) improves pain and well-being in people with advanced cancer already receiving a strong opioid regimen: a randomized, double-blind, placebo-controlled cross-over trial.

PURPOSE: To determine whether adding regular acetaminophen (paracetamol) could improve pain and well-being in people with advanced cancer and pain despite strong opioids. PATIENTS AND METHODS: Participants took acetaminophen for 48 hours and placebo for 48 hours. The order (acetaminophen or placebo first) was randomly allocated. Pain was the primary outcome. Preferences, number of opioid breakthrough doses, overall well-being, nausea and vomiting, drowsiness, constipation, and cold sweats were secondary outcomes. Patients rated themselves daily with visual analog scales (VAS) and a verbal numeric scale (VNS) for pain, all scaled from 0 to 10. RESULTS: Thirty patients completed the trial. The oral opioid was morphine in 23 patients and hydromorphone in seven patients. The median daily opioid dose in oral morphine equivalents was 200 mg (range, 20 to 2,100 mg). Nonsteroidal anti-inflammatory drugs, corticosteroids, or both were used by 16 patients. Pain and overall well-being were better for patients receiving acetaminophen than for those receiving placebo. The mean difference was 0.4 (95% CI, 0.1 to 0.8; P =.03) in VNS for pain, 0.6 (95% CI, -0.1 to 1.3; P =.09) in VAS for pain, and 0.7 (95% CI, 0.0 to 1.4; P =.05) in VAS for overall well-being. More patients preferred the period they took acetaminophen (n = 14) than the period they took placebo (n = 8), but many had no preference (n = 8). There were no differences in the other outcomes. CONCLUSION: Acetaminophen improved pain and well-being without major side effects in patients with cancer and persistent pain despite a strong opioid regimen. Its addition is worth considering in all such patients.