Six-month Intervention Research Articles

Impact of a Social Worker in a Glaucoma Eye Care Service: A Prospective Study.

The purpose of this study was to evaluate the effects of a six-month social worker intervention for participants with a glaucoma-related diagnosis in an urban ophthalmic setting (N = 40). The social worker assessed common barriers to eye care, helping participants with transportation, access to low-vision resources, and supportive counseling. The Distress Thermometer, Patient Health Questionnaire-9, and a satisfaction survey were administered to determine the effect of the social worker intervention and participants' overall impressions of the social worker. The most common barrier to eye care was emotional distress (77.5 percent). There was a significant decrease in the number of participants with symptoms of major and moderate depression. Fourteen participants experienced a clinically relevant decrease in depression, 37 participants felt that the social worker's support addressed their issues, and 29 participants thought it helped them in managing their glaucoma. This study provides evidence that a social work intervention may improve care coordination and management of individuals afflicted with vision impairment due to glaucoma and other ocular diseases.

1150. Cleaning High Touch Surfaces of Patients’ Rooms: Make It Easier, and It Simply Gets Cleaner

BackgroundThe healthcare environment has been established as a reservoir for human pathogens and specifically multidrug-resistant organisms (MDRO). High touch surfaces and fomites in a patient’s room mediate transmission between infected and uninfected patients and personnel. Efforts to reduce hospital-associated infections due to MDROs often focus on room cleaning; however, adherence to and thoroughness of cleaning pose significant challenges.MethodsA crossover trial was implemented in January 2016 (for 15 months) at Assaf Harofeh Medical Center (Israel) in four identical medical units. Single-use wipes (Clinell®; universal wipes and sporicidal wipes for rooms of patients with C. difficile), were compared with common practices which consisted of reusable cloths and bleach (1,000–5,000 ppm). Six-month cleaning and intervention periods were used on units in alternating sequences, separated by washout periods. Cleaning was monitored twice a week (bedrail, bedside table, clinical binder, call button, and lamp switch), by a fluorescent marker system (Clinell®). Comparisons used GEE with clustering for room. Staff were surveyed on intervention feasibility, acceptability, and satisfaction.ResultsComplete cleaning in all five test locations was found in 23% of 400 total assessments and was more common in the intervention group (34% vs. 12%; OR = 3.7; P < 0.001). Cleaning adherence was highest for the bed rail (71%) and lowest for the call button (38%). The use of wipes had the largest effect on adherence for the light switch (59% vs. 26%; OR = 4.2; P < 0.001). Intervention timing was not associated with overall adherence (P = 0.10). 94% of staff reported overall satisfaction of “very good” or “excellent,” and 90% of staff reported that use of the wipes shortened the cleaning process.ConclusionThe use of cleaning wipes resulted in greater adherence to room cleaning and the method was reported to be acceptable to staff. Future aims of this large study (over 10,000 patients were enrolled and data collection not yet completed) are to determine the impact of this intervention on rates of hospital-acquired infections, MDRO acquisitions, and mortality.Disclosures E. T. Martin, Clinell: Grant Investigator, Research grant. D. Marchaim, Clinell: Grant Investigator, Grant recipient.

Effect of exercise and nutritional supplementation on health-related quality of life and mood in older adults: the VIVE2 randomized controlled trial

BackgroundHealth-related quality of life (HRQoL) and absence of depressive symptoms are of great importance for older people, which may be achieved through lifestyle interventions, e.g., exercise and nutrition interventions. The aim of this investigation was to analyze the effects of a physical activity program in combination with protein supplementation on HRQoL and depressive symptoms in community-dwelling, mobility-limited older adults.MethodsIn the Vitality, Independence, and Vigor 2 Study (VIVE2), community-dwelling men and women with an average age of 77.5 ± 5.4 years, some mobility limitations and low serum vitamin D levels (25(OH)Vit D 22.5–60 nmol/l) from two study sites (Stockholm, Sweden and Boston, USA) were randomized to receive a nutritional supplement or a placebo for 6 months. All took part in a physical activity program 2–3 times/ week. The primary outcome examined in VIVE2 was 400 M walk capacity. HRQoL was measured using the Medical Outcomes Study 36-item Short Form Health Survey (SF36), consisting of the Physical Component Summary (PCS) and Mental Component Summary (MCS), and depressive symptoms were measured using The Centre for Epidemiologic Studies Depression Scale (CES-D). In the sensitivity analyses, the sample was divided into sub-groups based on body measures and function (body mass index (BMI), appendicular lean mass index (ALMI), handgrip strength and gait speed).ResultsFor the whole sample, there was a significant improvement in both MCS, mean (95% CI) 2.68 (0.5, 4.9) (p 0.02), and CES-D -2.7 (− 4.5, − 0.9) (p 0.003) during the intervention, but no difference was detected between those who received the nutritional supplement and those who received the placebo. The results revealed no significant change in PCS or variation in effects across the sub-categories.ConclusionsThis study demonstrates that a six-month intervention using a physical activity program had positive effects on mental status. No additional effects from nutritional supplementation were detected.Trial registrationRegistered at ClinicalTrials.gov, March 2 2012, NCT01542892.

Gut Permeability Might be Improved by Dietary Fiber in Individuals with Nonalcoholic Fatty Liver Disease (NAFLD) Undergoing Weight Reduction.

(1) Introduction: Zonulin (ZO) has been proposed as a marker of intestinal permeability. Only a few studies have analyzed to date how diet influences the serum concentration of ZO among patients with non-alcoholic fatty liver disease (NAFLD). We performed a six-month dietetic intervention to evaluate the association between fiber intake and ZO concentration in 32 individuals with NAFLD. (2) Methods: Fiber content in the diet was estimated by Food Frequency Questionnaire (FFQ) and by analyzing 72-h nutritional diaries. ZO concentrations in serum were measured before and after the intervention by immunoenzymatic assay (ELISA). Fatty liver was quantified using the Hamaguchi score before and after the dietetic intervention. (3) Results: During the intervention, the dietary fiber intake increased from 19 g/day to the 29 g/day concomitant with an increase in the frequency of fiber consumption. All patients experienced significant (all p < 0.05) improvements in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGTP) activities. We also detected decreased serum triglycerides (p = 0.036), homeostatic model assessment insulin resistance (HOMA-IR (p = 0.041) and insulin content (p = 0.34), and improvement of fatty liver status according to the Hamaguchi score (p = 0.009). ZO concentration in serum decreased by nearly 90% (7.335 ± 13.492 vs. 0.507 ± 0.762 ng/mL, p = 0.001) and correlated with the amount of dietary fiber intake (p = 0.043) as well as the degree of fatty liver (p = 0.037). (4) Conclusion: Increasing nutritional fiber results in reduced serum ZO levels, reduced liver enzymes and improved hepatic steatosis in patients with NAFLD, possibly by altering intestinal permeability. Increased dietary fiber intake should be recommended in patients with NAFLD.

Telemonitoring to improve nutritional status in community-dwelling elderly: design and methods for process and effect evaluation of a non-randomized controlled trial

BackgroundA good nutritional status is key for maintaining health and quality of life in older adults. In the Netherlands, 11 to 35% of the community-dwelling elderly are undernourished. Undernutrition or the risk of it should be signalled as soon as possible to be able to intervene at an early stage. However, in the context of an ageing population health care resources are scarce, evoking interest in health enabling technologies such as telemonitoring. This article describes the design of an intervention study focussing at telemonitoring and improving nutritional status of community-dwelling elderly.MethodsThe PhysioDom Home Dietary Intake Monitoring intervention was evaluated using a parallel arm pre-test post-test design including 215 Dutch community-dwelling elderly aged > 65 years. The six-month intervention included nutritional telemonitoring, television messages, and dietary advice by a nurse or a dietician. The control group received usual care. Measurements were performed at baseline, after 4.5 months, and at the end of the study, and included the primary outcome nutritional status and secondary outcomes behavioural determinants, diet quality, appetite, body weight, physical activity, physical functioning, and quality of life. Furthermore, a process evaluation was conducted to provide insight into intervention delivery, feasibility, and acceptability.DiscussionThis study will improve insight into feasibility and effectiveness of telemonitoring of nutritional parameters in community-dwelling elderly. This will provide relevant insights for health care professionals, researchers, and policy makers.Trial registrationThe study was retrospectively registered at Clinical-Trials.gov (identifier NCT03240094) since August 3, 2017.

A lifestyle intervention improves sexual function of women with obesity and infertility: A 5 year follow-up of a RCT.

BackgroundObesity and infertility are associated with poorer sexual function. We have previously shown that a lifestyle intervention in women with obesity and infertility reduced weight and improved cardiometabolic health and quality of life, which may positively affect sexual function. We now report on sexual function 5 years after randomization.Methods and findingsIn total 577 women, between 18–39 years of age, with infertility and a BMI ≥29 kg/m2 were randomized to a six-month lifestyle intervention targeting physical activity, diet and behavior modification or prompt infertility care as usual. Intercourse frequency and sexual function were assessed with the McCoy Female Sexuality Questionnaire (MFSQ), 5.4±0.8 years after randomization. 550 women could be approached for the follow-up study, of whom 84 women in the intervention and 93 in the control group completed the MFSQ. Results were adjusted for duration of infertility, polycystic ovary syndrome and whether women were attempting to conceive. The intervention group more often reported having had intercourse in the past 4 weeks compared to the control group (aOR: 2.3 95% CI 0.96 to 5.72). Among women reporting intercourse in the past 4 weeks, the intervention group (n = 75) had intercourse more frequently (6.6±5.8 vs. 4.9±4.0 times; 95% CI 0.10 to 3.40) and had higher scores for vaginal lubrication (16.5±3.0 vs. 15.4±3.5; 95% CI 0.15 to 2.32) and total ‘sexual function’ score (96.5±14.2 vs. 91.4±12.8; 95% CI 0.84 to 9.35) compared to the control group (n = 72). Sexual interest, satisfaction, orgasm and sex partner scores did not differ statistically between the groups. The intervention effect on sexual function was for 21% mediated by the change in moderate to vigorous physical activity.ConclusionA six-month lifestyle intervention in women with obesity and infertility led to more frequent intercourse, better vaginal lubrication and overall sexual function 5 years after the intervention. (Trial Registration: NTR1530).

A Personal Decision Support System for Heart Failure Management (HeartMan): study protocol of the HeartMan randomized controlled trial

BackgroundHeart failure (HF) is a highly prevalent chronic disease, for which there is no cure available. Therefore, improving disease management is crucial, with mobile health (mHealth) being a promising technology. The aim of the HeartMan study is to evaluate the effect of a personal mHealth system on top of standard care on disease management and health-related quality of life (HRQoL) in HF.MethodsHeartMan is a randomized controlled 1:2 (control:intervention) proof-of-concept trial, which will enrol 120 stable ambulatory HF patients with reduced ejection fraction across two European countries. Participants in the intervention group are equipped with a multi-monitoring health platform with the HeartMan wristband sensor as the main component. HeartMan provides guidance through a decision support system on four domains of disease management (exercise, nutrition, medication adherence and mental support), adapted to the patient’s medical and psychological profile. The primary endpoint of the study is improvement in self-care and HRQoL after a six-months intervention. Secondary endpoints are the effects of HeartMan on: behavioural outcomes, illness perception, clinical outcomes and mental state.DiscussionHeartMan is technologically the most innovative HF self-management support system to date. This trial will provide evidence whether modern mHealth technology, when used to its full extent, can improve HRQoL in HF.Trial registrationThis trial has been registered on https://clinicaltrials.gov/ct2/show/NCT03497871, on April 13 2018 with registration number NCT03497871.

Making dietary changes following a diagnosis of prediabetes: a qualitative exploration of barriers and facilitators

To explore the experiences of people recently diagnosed with prediabetes and overweight or obese in making dietary changes following a six-month primary care nurse-delivered dietary intervention pilot. Semi-structured interviews were conducted with 20 participants, purposefully selected to ensure a mix of ethnicity, gender and glycaemic outcome. Thematic analysis of interview data was undertaken. Participants described feeling shocked when they received the diagnosis of prediabetes. Three core themes, each containing subthemes, emerged: (i) supportive factors - determination not to develop diabetes, clear information and manageable strategies, and supportive relationships; (ii) barriers - lack of family support, financial constraints, social expectations around food, and chronic health issues; and (iii) overcoming challenges - growing and sharing food, using frozen vegetables and planning. Challenges related to cultural expectations around providing and partaking of food were more evident for indigenous Māori participants. A diagnosis of prediabetes provides a window of opportunity for healthcare professionals to work with those diagnosed and their families to make healthful dietary changes. Dietary guidance is likely to be most effective when individuals' life circumstances are taken into account. Clear information and supportive relationships to facilitate lifestyle change are extremely important. (Clinical Trials Registry No; ANZCTR ACTRN1261500080656).

Effectiveness of a Community Health Worker-Led Diabetes Intervention among Older and Younger Latino Participants: Results from a Randomized Controlled Trial.

Diabetes management for older Latino adults is complex, given a higher incidence of multiple coexisting medical conditions and psychosocial barriers to self-management. Community health workers (CHWs) may be effective in reducing these barriers. The REACH Detroit CHW randomized controlled intervention studies with Latino/as with diabetes found improvements in self-management behaviors and glucose control after participating in a CHW-led intervention. Using data from the REACH Detroit Partnership′s cohort 3, this study used descriptive statistics and multiple linear regression analyses to evaluate whether the six-month CHW intervention had a greater effect on older Latino/as (ages 55 and older) than younger participants between baseline and post-intervention follow-up at six months. There were significant intervention effects by age group that varied by outcome. Compared to a control group that received enhanced usual care, there were statistically significant intervention effects demonstrating greater self-efficacy scores 1.27 (0.23, 2.32); p < 0.05, and reductions in HbA1c 1.02 (−1.96, −0.07); p < 0.05, among older participants in the CHW intervention, and increases in diabetes support 0.74 (0.34, 1.13); p < 0.001; and understanding of diabetes management 0.39 (0.08, 0.70); p < 0.01 among younger participants.

Scale up of a multi-strategic intervention to increase implementation of a school healthy canteen policy: findings of an intervention trial

BackgroundImplementation interventions delivered in schools to improve food provision have been found to improve student diet and reduce child obesity risk. If the health benefits of food availability policies are to be realised, interventions that are effective need to be implemented at scale, across an entire population of schools. This study aims to assess the potential effectiveness of an intervention in increasing the implementation, at scale, of a healthy canteen policy by Australian primary schools.MethodsA non-controlled before and after study was conducted in primary schools located in the Hunter New England region of New South Wales, Australia. Schools received a multi-component intervention adapted from a previous efficacious and cost-effective randomised control trial. The primary trial outcome was the proportion of canteen menus compliant with the state healthy canteen policy, assessed via menu audit at baseline and follow-up by dietitians. Secondary outcomes included policy reach and adoption and maintenance policy implementation.ResultsOf the 173 schools eligible for inclusion in the trial, 168 provided menus at baseline and 157 menus were collected at follow-up. At follow-up, multiple imputation analysis found 35% (55/157) of schools compared to 17% (29/168) at baseline (OR = 2.8 (1.6–4.7), p = < 0.001) had menus compliant with the state healthy canteen policy. As an assessment of the impact of the intervention on policy reach, canteen manager and principal knowledge of the policy increased from 64% (n = 76) and 38% (n = 44) respectively at baseline to 69% (n = 89) and 60% (n = 70) at follow-up (p = 0.393, p = 0.026). Adoption of the policy increased from 80% (n = 93) at baseline to 90% (n = 104) at follow-up (p = 0.005) for principals, and from 86% (n = 105) to 96% (n = 124) (p = 0.0001) for canteen managers. Multiple imputation analysis showed intervention effects were maintained six-months post intervention (33% of menus compliant OR = 2.6 (1.5–4.5), p = < 0.001 compared to baseline).ConclusionsThis study found school canteen compliance with a healthy food policy increased in association with a multi-strategy intervention delivered at scale. The study provides evidence for public health policy makers and practitioners regarding strategies and modes of support required to support improvement in nutrition policy implementation across entire populations of schools.

BASELINE POSTERIOR CINGULATE CORTEX-MEDIAL TEMPORAL/HIPPOCAMPAL NETWORKS IN MCI PREDICTS THE EFFECT OF COGNITIVE TRAINING

Mild cognitive impairment (MCI) is well known as a state between normal aging and Alzheimer's disease (AD). Cognitive training has been widely studied for its prevention effect in MCI patients. The results are controversial in different clinical trials. Cognitive training might work by modulating neural plasticity, and the threshold of modulation varies between individuals. It is important to find out prognostic neural markers for the effect of cognitive training before such intervention. We recruited thirty MCI patients and trained them for six months. Training covered memory, attention, language, visual spatial and executive function. Mini-mental state examination (MMSE) was done before and after training. Resting state functional MRI (Rs-fMRI) was also performed before training. MMSE of AD patients decrease 2 points per year according to epidemiological study. After six-month intervention, we grouped these patients by their MMSE difference between endpoint and baseline. Progressed group has 12 patients, which is defined by 1 points MMSE reduction. Effective group has 18 patients, which is defined by less than 1 points reduction of MMSE. Blood oxygenation level-dependent signals (BOLD) from fMRI were analyzed after pre-processing. We used seed-based functional connectivity (FC) for extracting default mode network (DMN) by seed in the posterior cingulate cortex (PCC). We also explored the connectivity between bilateral hippocampus and other voxels in the brain and compared the two groups with each other. Two groups were similar in their age, education level and baseline cognitive tests (MMSE, auditory verbal learning test, shape trail test, symbol digit substitution test, stroop color-word test and complex figure test). Baseline DMN of effective group showed increased connectivity between cortex peripheral to right lateral fissure and PCC. FC between bilateral hippocampus and PCC was also stronger in effective group than progressed group.

Abstract C68: Addressing negative cognitive and affective factors to increase colorectal cancer screening for African Americans

Abstract Introduction/Background: Given the lower colorectal cancer (CRC) screening rates and higher mortality for African Americans in the U.S., there is a critical need for effective interventions–especially at the community level (due to lower physician referrals)--to encourage appropriate CRC screening. Prior research on decision making for CRC screening has shown that both cognitive (e.g., expected utility beliefs) and affective factors (e.g., embarassment, fear, disgust about screening tests) influence screening behavior and intentions. The purpose of this study was to test the effectiveness of a community-based intervention to address cognitive and affective determinants of screening in order to positively influence behavior change and increase CRC screening. This presentation reports the contextual factors reported in interviews in response to the educational program and video that influenced the understanding and behavior change of participants to seek CRC screening. Methods: This study used a randomized experimental design with pre-post assessments of key dependent variables, plus qualitative interviews of a subsample of participants at one-week and six-months post intervention. African American male and female participants &amp;gt;50 years of age from Buffalo and New York, New York were randomized by program session to receive either a one-time, narrative communication or fact-based, didactic video and educational session about CRC and screening using colonoscopy. Qualitative findings were organized and analyzed using NVivo and the PEN-3 framework. Results: A total of 333 study eligible African Amercian men and women from the two sites were randomized, and 1-week (n=39) and 6-month (n=26) interviews were completed. There were no significant demographic or screening intention differences in this qualitative sample between attendees of the didactic (n=31) and narrative (n=34) programs at baseline. Reported changes in awareness and feelings about colonoscopy in response to the videos demonstrated positive influences on the “Perceptions,” affective associations, and cognitive factors related to colonoscopy with the highest number (30 v. 23 responses) and the most dramatic responses reported by participants in the Narrative Communication video sessions. Participant responses in the Narrative group included discussion of how the video and program increased comfort level with the test; reduced anxiety, fear, and stress related to the test; increased understanding of the test itself, why and how it is done; and provided a basis for understanding how colonoscopy actually prevents CRC. Presentation of response examples within the PEN-3 framework will elucidate how qualities in the videos may have served to change and influence participants' feelings and knowledge to positively impact CRC screening. Conclusion: Discourse analysis findings from this study suggest that this community-based intervention using culturally targeted, racially concordant videos is an effective tool to convert existing negative cognitive and affective factors that are recognized barriers to CRC screening. Pertinent to these findings, prior baseline analysis (manuscript under review) of the total study sample showed greater need to address knowledge, perceived benefits, and negative feelings about colonoscopy, particularly among African Americans with lower income and education. Therefore, these qualitative findings further support and explain how the video and educational intervention, especially the narrative video, may be especially impactful in addressing social determinants of screening disparities among less educated and lower income African Americans. Citation Format: Deborah O. Erwin, Marc Kiviniemi, Lynne Klasko, Elisa M. Rodriguez, Frances G. Saad-Harfouche, Erin Ellis, Lina Jandorf. Addressing negative cognitive and affective factors to increase colorectal cancer screening for African Americans [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr C68.

The Association between Eating Traits and Weight Change after a Lifestyle Intervention in People with Type 2 Diabetes Mellitus.

Aims To date, studies on the role of eating traits in weight loss success have only included obese people without type 2 diabetes mellitus (T2DM), thereby disregarding negative effects of T2DM-related metabolic changes. Our aim was to assess the association between eating traits and weight change after a lifestyle intervention in people with T2DM. Methods For the current study, we reexamined data from a six-month intervention in 120 participants. We determined eating traits at baseline, using the DEBQ, which were used to produce three groups: unsuccessful dietary restrained (high restraint, high emotional/external eating scores), successful dietary restrained (high restraint, low emotional/external eating scores), and reference (low restraint, high or low emotional/external eating scores). Linear regression was used to study the association between the eating trait groups and weight changes after six months, while correcting for possible confounders. Results On average, the weight loss success was limited, with a third of the participants being weight stable, a third losing weight > −1 kg (average loss −2.6 ± 1.9 kg), and a third gaining weight > +1 kg (average gain +3.3 ± 1.9 kg). When compared to the reference group, the unsuccessful dietary restrained gained weight during the intervention (beta = 1.2 kg, confidence interval (CI)% = 0.1; 2). No significant change was observed in the succesful dietary restrained group. Conclusions The eating trait of being unsuccessfully dietary restrained is associated with weight-loss failure after a six-month lifestyle intervention in people with T2DM.

The impact of group-based Tai chi on health-status outcomes among community-dwelling older adults with hypertension

ObjectivesTo test the effects of group-based Tai chi on health-status outcomes among older adults with hypertension. BackgroundA high-quality study exploring the effects of Tai chi on physical and psychosocial health for older adults with hypertension is needed in China. The long-term effects of group-based Tai chi in Chinese older adults with hypertension remain unclear. MethodsA randomized controlled trial was conducted. The group-based Tai chi training and practice were implemented in older adults over six-month. ResultsThe Tai chi (TC) group showed significantly lower blood pressure and body mass index than the usual care (UC) group. The TC group participants showed greater improvements in social support, quality of life, and reduction in depressive symptoms over a six-month intervention than UC group. TC group showed significant group-by-time interactions in these variables. ConclusionGroup-based Tai chi is effective in the enhancement of health-status outcomes for older Chinese adults with hypertension.

Economic incentive and social influence to overcome household waste separation dilemma: A field intervention study

China has experienced a rapid growth of solid waste over the years, household waste source-separation is becoming a nationwide strategy for promoting recycling economy and improving urban environmental sustainability. Waste separation, however, may end in failure due to the free-rider problem similarly existing in other pro-environmental collective actions. Along with the economic and sociological/social psychological logic respectively, this study tested the effects of economic incentive and social influence, which are theoretically considered as two general solutions to domestic waste separation dilemma. One hundred and eighty-eight residents in the three communities of Hangzhou, Zhejiang Province were assigned to a control group or one of two experimental scenarios, where they were encouraged to participate in waste separation activities through either the economic rewards given on their performance, or door-stepping campaigns aimed at constructing a supportive social environment. Six-month intervention effects were analyzed and showed that economic inducement was more effective than social mobilization in promoting waste separation. Further mediation tests indicated that self-efficacy partially mediated the effects of both strategies, while personal norms were positively associated with two treatments instead of behavior demonstration. In addition, the moderating effects of several socio-demographic factors on psychological mechanisms were also explored. The findings, limitations and implications for future research and policy are discussed in the concluding section.

Association between periconceptional weight loss and maternal and neonatal outcomes in obese infertile women.

BackgroundObesity in women of reproductive age has deleterious effects on reproductive and offspring health. In this study, we aimed to evaluate the association between the magnitude of periconceptional body-mass index (BMI) change and maternal and neonatal outcomes in obese infertile women who participated in the LIFEstyle study. The LIFEstyle study was a randomized controlled trial, evaluating if a six-month lifestyle intervention program prior to infertility treatment in obese infertile women improved birth rates, compared to prompt infertility treatment.Methods and findingsThis is an exploratory post hoc analysis of the LIFEstyle study. We recorded periconceptional BMI change in women with an ongoing pregnancy, pooling data of all women, regardless of randomization arm. Periconceptional BMI change was calculated using weight at randomization and the periconceptional weight (measured in kilograms 12 weeks before or after conception and expressed as BMI change in units BMI (kg/m2)). Subsequently, women were categorized into quartiles according to the magnitude of their periconceptional change in BMI. The odds of maternal and neonatal outcomes were calculated using logistic regression analysis, comparing women in each of the first three weight change quartiles separately, and combined, to women in the fourth quartile. The fourth quartile was chosen as reference group, since these women had the least weight loss. We adjusted for periconceptional BMI, nulliparity and smoking status. In addition, we performed a subgroup analysis for singleton pregnancies. In the LIFEstyle study, 321 obese infertile women achieved an ongoing pregnancy which was conceived within 24 months after randomization. Periconceptional BMI change was available in 244 of these women (76%). Median BMI at randomization was 35.9 kg/m2. Women in the first quartile (Q1) had a periconceptional BMI change of <-2.1 kg/m2, women in the second quartile (Q2) -2.1 to -0.9 kg/m2, women in the third quartile (Q3) -0.9 to 0.1 kg/m2 and women in the fourth quartile (Q4) gained ≥0.1 kg/m2. There were no significant differences between women in the quartiles regarding rates of excessive gestational weight gain (in term pregnancies), gestational diabetes, preterm birth, induction of labor, spontaneous vaginal birth and Caesarean section. Compared to women in Q4, the adjusted odds ratios, aOR, and 95% confidence interval for a hypertensive complication were; 0.55 (0.22–1.42) for women in Q1, 0.30 (0.12–0.78) for women in Q2, 0.39 (0.16–0.96) for women in Q3 and 0.39 (0.19–0.82) for women in Q1 to Q3 combined. In the subgroup analysis, investigating singleton pregnancies only, the statistically significant decreased rate of a hypertensive complication remained in women in Q2 (aOR 0.27, 95% CI 0.10–0.72) and Q3 (aOR 0.39, 95%CI 0.16–0.98) and when comparing women in Q1 to Q3 together to women in Q4 (aOR 0.38, 95%CI 0.18–0.80). Furthermore, there was a significantly decreased aOR (95%CI) of preterm birth in women in Q2 (0.24, 0.06–0.98) and when combining women in Q1 to Q3 (0.37, 0.14–0.97) compared to women in Q4.ConclusionsThese results suggest that a periconceptional decrease in BMI in obese infertile women could lead to a decrease of the rates of hypertensive pregnancy complications and preterm birth. The results are limited by the exploratory nature of the analyses and further evidence is necessary to provide more definitive conclusions.

Households energy conservation in Saudi Arabia: Lessons learnt from change-agents driven interventions program

Abstract Saudi Arabia is one of the most energy intensive countries in the world in terms of per capita consumption. Highly subsidized energy prices and low tariffs are driving up domestic energy consumption. The rapidly growing energy demand has prompted the country to undertake several energy-saving measures. These initiatives, however, are all technology driven and no apparent measures have yet been taken to modify end users' behavior. In order to reduce the rate of growth of residential energy consumption, besides appropriate regulations, it is critical to engage end users through better education and awareness. Thus, this study aims to investigate the impact of behavior-based, non-technical interventions on end users' perceptions of energy conservation and, subsequently, any actual reduction in household energy consumption. Taking Khobar city as the geographical focus, 88 participating households were randomly chosen for interventions. The households were divided into two treatment and one control group. Analysis of the six-month intervention revealed a positive but statistically insignificant impact on energy conservation. The results suggest that there is a positive relation between the number of adults in the family and level of education with the energy consumption while number of female members in family, family size, building area shows a negative association attributing to ‘economies of scale’ and existence of pro-environmental behavior. In the end, this study attempts to build a foundational ground for policy prescription on energy conservation based on ‘investment’ and ‘curtailment’ behavior approaches to assess the ‘longevity’ effects.

Exercise and weight loss interventions and miRNA expression in women with breast cancer.

Obesity and weight gain are associated with comorbidities including a higher risk of tumor recurrence and cancer-related deaths among breast cancer (BC) survivors; however, the underlying mechanisms linking obesity and cancer are poorly understood. Given the lack of clinically validated BC biomarkers, obesity and weight-loss studies utilize serum biomarkers as the intermediary outcomes of tumor recurrence. Studies have indicated microRNAs (miRNA)s are reliable biomarkers for cancer. We hypothesized that miRNA expression correlates with obesity and weight loss amongst BC survivors. This would yield insight into the biological pathways bywhich this association occurs, enabling more precise development of therapeutics. We correlated baseline body mass index (BMI) with serum miRNA expression in 121 BC survivors enrolled in the Hormones and Physical Exercise (HOPE) trial. We then analyzed expression of the 35 most abundant miRNAs from HOPE in a six-month randomized controlled weight-loss trial (Lifestyle, Exercise, and Nutrition; LEAN) in 100 BC survivors. Ingenuity pathway analysis (IPA) software was used to identify biological pathway targets of the BMI-associated and intervention-responsive miRNAs using predictive biomarkers. Pearson correlations in HOPE identified eight miRNAs associated with BMI, including miR-191-5p (r = -0.22, p = 0.016) and miR-122-5p (r = 0.25, p = 0.0048). In the LEAN validation study, levels of miR-191-5p significantly increased during the six-month intervention (p = 0.082). Ingenuity Pathway Analysis identified "Estrogen-mediated S-phase entry" (HOPE p = 0.003; LEAN p < 0.001) and "Molecular mechanisms of cancer" (HOPE p = 0.02; LEAN p < 0.001) as the top canonical pathways that significantly correlated with BMI-associated and intervention-responsive miRNAs and contain obesity and cancer-relevant genes including the E2F family of transcription factors and CCND1, which have been implicated in sporadic BC. While the association between obesity and BC recurrence and mortality has been demonstrated in the literature, mechanisms underlying the link between weight gain and cancer are unclear. Using two independent clinical trials, we identified novel miRNAs associative to BMI and weight loss thatcontribute to the development of cancer. Predictive modeling of miRNA targets identified multiple canonical pathways associated with cancer, highlighting potential mechanisms explaining the link between BMI and increasedcancerrisk.

Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy

The Exercise Program in Cancer and Cognition (EPICC) Study is a randomized controlled trial designed to test the effects of moderate-intensity aerobic exercise on cognitive function in postmenopausal women with early-stage breast cancer during the first six months of aromatase inhibitor therapy. It is estimated that up to 75% of survivors of breast cancer experience cognitive impairment related to disease and treatment. At present, there are no known interventions to improve or manage cognitive function for women with breast cancer. Here, we describe a single-blinded, randomized controlled trial with allocation of 254 postmenopausal women with early-stage breast cancer to a supervised six-month aerobic exercise intervention or usual care. Prior to beginning aromatase inhibitor (AI) therapy, participants complete baseline assessments of cognitive function, cardiorespiratory fitness, blood-based biomarkers, physical activity and sleep, and symptoms (fatigue, sleep problems, depressive symptoms, anxiety). A random subset of participants (n = 150) undergoes neuroimaging procedures that include structural and functional magnetic resonance imaging assessments. All participants maintain an activity diary; physical activity and sleep monitoring is repeated three and seven months post-randomization. The remaining baseline assessments are repeated seven months post-randomization. If successful, exercise could be a low-cost method to improve cognitive function in women with breast cancer that is easily adaptable to the home or community.Trial registration: Clinicaltrials.govNCT02793921. Registered 20 May 2016.

Identification of potential ‘lifestyle-responsive’ epigenomic biomarkers in healthy women aged 18–40

Context: Human health is complex and multifaceted; there is a need for biomarkers that reflect the multidimensional nature of health.Objective: To identify potential epigenomic biomarkers of health in women aged 18–40 participating in a six-month lifestyle intervention, next level health.Materials and methods: Methylation data were obtained by reduced representation bisulphite sequencing of 21 female intervention participants as well as three non-participants. The Differential Methylation Analysis Package (DMAP) was used to investigate inter- and intra-individual variability and to identify potential targets of transient epigenetic control in the population studied.Results: Eleven genes were identified as significantly differentially methylated post- intervention in all 21 participants. 1884 genomic locations were found to be differentially methylated amongst the total female population studied representing potential epigenomic biomarkers.Conclusions: The ability to demonstrate epigenetic changes arising from a lifestyle intervention can provide key information on the relationship between gene regulation, human behaviour and health.