INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention – study protocol of a multicentre randomised controlled trial

Abstract Background Excessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy. Methods INTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum. At week 6 postpartum, participants are randomised into the intervention or control arm of the study. The intervention focuses on weight, diet, physical activity and mental well-being, and comprises face-to-face coaching, in which behavioural change techniques are central, and use of a mobile application, which is Bluetooth-connected to a weighing scale and activity tracker. The intervention is rolled out postpartum (4 coaching sessions between week 6 and month 6) and in a new pregnancy (3 coaching sessions, one in each trimester of pregnancy); the mobile app is used throughout the two intervention phases. Data collection includes data from the medical record of the participants (pregnancy outcomes and medical history), anthropometric data (height, weight, waist- and hip circumferences, skinfold thickness and body composition by bio-electrical impedance analysis), data from the mobile app (physical activity and weight; intervention group only) and questionnaires (socio-demographics, breastfeeding, food intake, physical activity, lifestyle, psychosocial factors and process evaluation). Medical record data are collected at inclusion and at delivery of the subsequent pregnancy. All other data are collected at week 6 and month 6 postpartum and every subsequent 6 months until a new pregnancy, and in every trimester in the new pregnancy. Primary outcome is the composite endpoint score of pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, and large-for-gestational-age infant in the subsequent pregnancy. Discussion INTER-ACT is a unique randomised controlled lifestyle intervention trial in its implementation between pregnancies and during the subsequent pregnancy, with an e-health driven approach. Trial registration ClinicalTrials.gov Identifier: NCT02989142 . Registered August 2016

Acceptability and feasibility of a low-cost, theory-based and co-produced intervention to reduce workplace sitting time in desk-based university employees

BACKGROUND: Prolonged sedentary time is linked with poor health, independent of physical activity levels. Workplace sitting significantly contributes to sedentary time, but there is limited research evaluating low-cost interventions targeting reductions in workplace sitting. Current evidence supports the use of multi-modal interventions developed using participative approaches. This study aimed to explore the acceptability and feasibility of a low-cost, co-produced, multi-modal intervention to reduce workplace sitting. METHODS: The intervention was developed with eleven volunteers from a large university department in the UK using participative approaches and “brainstorming” techniques. Main components of the intervention included: emails suggesting ways to “sit less” e.g. walking and standing meetings; free reminder software to install onto computers; social media to increase awareness; workplace champions; management support; and point-of-decision prompts e.g. by lifts encouraging stair use. All staff (n = 317) were invited to take part. Seventeen participated in all aspects of the evaluation, completing pre- and post-intervention sitting logs and questionnaires. The intervention was delivered over four weeks from 7th July to 3rd August 2014. Pre- and post-intervention difference in daily workplace sitting time was presented as a mean ± standard deviation. Questionnaires were used to establish awareness of the intervention and its various elements, and to collect qualitative data regarding intervention acceptability and feasibility. RESULTS: Mean baseline sitting time of 440 min/workday was reported with a mean reduction of 26 ± 54 min/workday post-intervention (n = 17, 95 % CI = −2 to 53). All participants were aware of the intervention as a whole, although there was a range of awareness for individual elements of the intervention. The intervention was generally felt to be both acceptable and feasible. Management support was perceived to be a strength, whilst specific strategies that were encouraged, including walking and standing meetings, received mixed feedback. CONCLUSIONS: This small-scale pilot provides encouragement for the acceptability and feasibility of low-cost, multi-modal interventions to reduce workplace sitting in UK settings. Evaluation of this intervention provides useful information to support participatory approaches during intervention development and the potential for more sustainable low-cost interventions. Findings may be limited in terms of generalisability as this pilot was carried out within a health-related academic setting

DNA index shift with disease progression in colorectal adenocarcinoma: a morphological and flow cytometric study

DNA index (DI) values seen in 86 sporadic colorectal adenocarcinomas were related to clinical, morphological, and disease progression features. DI, whose overall distribution was bimodal with peaks in the diploid and from hypotriploid to tetraploid ranges, was related to pathological lymph node staging (pN), staging, lymphoid reaction, and tubular configuration. With increasing severity in pathological features, an irregular shift in DI class prevalence was seen, with no steady increase from diploidy to higher degrees of aneuploidy. All UICC stage I tumors (13% of total) were aneuploid, 50% being hypertriploid; diploidy (35%) and hypertriploidy (22%) prevailed in stage II carcinomas (41% of total), diploidy (35%) and hypotriploidy (30%) in stage III (30% of total), and triploidy (33%) in stage IV (15% of total). Amongst features related to stage (lymphoid reaction, depth of neoplastic embolization, grading, tubular configuration, and polymorphism), few were associated with DI, and none influenced DI shift and class prevalence through the stages. The biological capabilities of colorectal adenocarcinoma in relation to stage are expressed by certain aneuploid DI classes (hypertriploidy: absence of extracolonic spread; hypotriploidy: lymph node metastases; triploidy: distant metastases). Diploidy is unrelated to criteria defining stage above I and predicts 50% of cases with development of metachronous metastases. Irregular DI class shift through the stages may be attributable to different pathways of cancerogenesis and disease progression in diploid versus aneuploid carcinomas. Alternatively, assuming that the diploid fraction in aneuploid tumors contains neoplastic cells, pure diploid carcinomas represent the selection of a vital clone that may give rise to a further mixed population whose aneuploid DI is different and best fitted to express the biological capabilities of that given stage