Six-month Intervention Research Articles

A Nurse-led Approach to Improving Cardiac Lifestyle Modification in an Atrial Fibrillation Population.

Atrial fibrillation (AF) is a major public health problem and the most common cardiac arrhythmia encountered in clinical practice at this time. AF is associated with numerous symptoms such as palpitations, shortness of breath, and fatigue, which can significantly reduce health-related quality of life and result in serious adverse cardiac outcomes. In light of this, the aim of the present pilot study was to test the feasibility of implementing a mobile health (mHealth) lifestyle intervention titled “Atrial Fibrillation and Cardiac Health: Targeting Improving Outcomes via a Nurse-Led Intervention (ACTION),” with the goal of improving cardiac health measures, AF symptom recognition, and self-management. As part of this study, participants self-identified cardiac health goals at enrollment. The nurse used web-based resources from the American Heart Association (Dallas, TX, USA), which included the Life’s Simple 7® My Life Check® assessment, to quantify current lifestyle behavior change needs. Furthermore, on the My AFib Experience™ website (American Heart Association, Dallas, TX, USA), the patient used a symptom tracker tool to capture the date, time, frequency, and type of AF symptoms, and these data were subsequently reviewed by the cardiac nurse. Throughout the six-month intervention period, the cardiac nurse used a motivational interviewing approach to support participants’ cardiac health goals. Ultimately, the ACTION intervention was tested in 53 individuals with AF (mean age: 59 ± 11 years; 76% male). Participants were predominantly overweight/obese (79%), had a history of hypertension (62%) or hyperlipidemia (61%), and reported being physically inactive/not preforming any type of regular exercise (52%). The majority (88%) of the participants had one or more Life’s Simple 7® measures that could be improved. Most of the participants (98%) liked having a dedicated nurse to work with them on a biweekly basis via the mHealth portal. The most commonly self-reported symptoms were palpitations, fatigue/exercise intolerance, and dyspnea. Seventy percent of the participants had an improvement in their weight and blood pressure as documented within the electronic health record as well as a corresponding improvement in their Life’s Simple 7® score at six months. On average, there was a three-pound (1.36-kg) decrease in weight and a 5-mmHg decrease in systolic blood pressure between baseline and at six months. In conclusion, this pilot work provides initial evidence regarding the feasibility of implementing the ACTION intervention and supports testing the ACTION intervention in a larger cohort of AF patients to inform existing AF guidelines and build an evidence base for reducing AF burden through lifestyle modification.

Effect of physical therapy on early knee osteoarthritis with medial meniscal posterior tear assessed by MRI T2 mapping and 3D-to-2D registration technique: A prospective intervention study

Objectives: The purpose of this study was to verify that exercise aimed at improving knee kinematics in early-stage knee osteoarthritis (OA) patients with medial meniscus posterior root tears (MMPRTs) reduces knee adduction angle during gait and prevents rapid cartilage degeneration in the medial compartment of the knee.Methods: Subjects were randomly assigned to an adapting alignment exercise (AAE) group, with the goal of improving knee kinematics, and a muscle training and exercise (MTE) group. Before the start of the six-month intervention and following its completion, we performed an analysis of knee kinematics during gait using a 3D-to-2D registration technique and identified the area of cartilage degeneration using MRI T2 mapping.Results: The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: −0.14, 1.09) in the MTE group and −0.40° (−0.84, 0.04) in the AAE group (p = .039). The amount of change in the area of cartilage degeneration according to MRI T2 mapping expressed as MTE/AAE group was 7.7 mm2 (−0.4, 15.8)/−2.7 mm2 (−10.8, 5.3) at the posterior knee (p = .043).Conclusion: AAE could be a potential treatment method that improves the natural course of knee OA with MMRPTs.

Electrocardiographic changes following six months of long-distance triathlon training in previously recreationally active individuals

ABSTRACT Background: Clinical electrocardiographic (ECG) guidelines for athlete’s heart are based upon cross-sectional data. We aimed to longitudinally evaluate the influence of endurance training on the ECG and compare the prevalence of ECG abnormalities defined by contemporary criteria. Methods: A group of 66 training-naïve individuals completed a six-month training programme with resting ECGs and cardiopulmonary exercise tests performed at baseline, two and six months. Data were analysed using repeated measures analysis of variance and the prevalence of ECG abnormalities compared between proposed criteria. Results : Maximal oxygen consumption increased from 45.4 ± 7.1 to 50.3 ± 7.1 ml·kg−1·min−1 (p < 0.05) pre-to-post training. ECG changes included, bradycardia (60 ± 12 vs. 53 ± 8 beats·min−1; p < 0.05), shorter P wave duration (106 ± 10 vs. 103 ± 11 ms; p < 0.05), reduced QTc (413 ± 27 vs. 405 ± 22 ms; p < 0.05), and increased left ventricular Sokolow-Lyon index (2.45 ± 0.66 vs. 2.62 ± 0.78 mV; p < 0.05). 85% of individuals showed ≥1 ‘training-related’ ECG finding at six months vs. 68% at baseline. Using the 2013 Seattle Criteria, 4 ECGs were ‘abnormal’ at baseline and 3 at month six vs. 2 at baseline and 1 at month six, using the 2017 International Consensus. Prevalence of ‘borderline’ findings did not increase with training (11% at baseline and six months). Conclusion: Six-months endurance training leads to a greater prevalence of ‘training-related’ but not ‘borderline’ or ‘training-unrelated’ ECGs. ‘Borderline findings’ may not necessarily represent training-related cardiac remodelling in novice athletes following a six-month training intervention. KEY MESSAGES This study aimed to assess the longitudinal ECG changes following six months of endurance training, in training-naïve individuals, and whether these ECG changes support the revisions made to the recent 2017 international consensus criteria. The prevalence of ‘training-related’ findings were increased with six months of endurance training, however the prevalence of the revised ‘borderline’ criteria, according to the 2017 international consensus, did not increase and the associated quantitative ECG data (e.g. P-wave amplitude, QRS axis and QRS duration) remained unchanged. Further clinical consideration may be warranted for individuals within the early phase of exercise engagement presenting with ‘borderline’ ECG abnormalities, defined by the International criteria.

Higher striatal D2-receptor availability in aerobically fit older adults but non-selective intervention effects after aerobic versus resistance training

There is much evidence that dopamine is vital for cognitive functioning in aging. Here we tested the hypothesis that aerobic exercise and fitness influence dopaminergic neurotransmission in the striatum, and in turn performance on offline working-memory updating tasks. Dopaminergic neurotransmission was measured by positron emission tomography (PET) and the non-displacable binding potential (BPND) of [11C]raclopride, i.e. dopamine (DA) D2-receptor (D2R) availability. Fifty-four sedentary older adults underwent a six-months exercise intervention, performing either aerobic exercise or stretching, toning, and resistance active control training. At baseline, higher aerobic fitness levels (VO2peak) were associated with higher BPND in the striatum, providing evidence of a link between an objective measure of aerobic fitness and D2R in older adults. BPND decreased substantially over the intervention in both groups but the intervention effects were non-selective with respect to exercise group. The decrease was several times larger than any previously estimated annual decline in D2R, potentially due to increased endogenous DA. Working-memory was unrelated to D2R both at baseline and following the intervention. To conclude, we provide partial evidence for a link between physical exercise and DA. Utilizing a PET protocol able to disentangle both D2R and DA levels could shed further light on whether, and how, aerobic exercise impacts the dopaminergic system in older adults.

Effect of aerobic exercise on white matter microstructure in the aging brain

Aging is associated with decline in white matter (WM) microstructure, decreased cognitive functioning, and increased risk of Alzheimer’s disease and related dementias. Recent research has identified aerobic physical exercise as a promising intervention for increasing white matter microstructure in aging, with the aim of increasing cognitive abilities, and protecting against neurodegenerative processes. However, the degree to which white matter microstructure can be protected or improved with exercise remains incompletely understood. Here, a sub-group of 25 healthy, sedentary participants (aged 57 to 86 years; M = 67.1; SD = 7.9; 11 female, 14 male) from the larger Brain in Motion Study (Tyndall et al., 2013) underwent diffusion tensor imaging (DTI) before and after a six-month aerobic exercise intervention. DTI data were analysed with FSL’s Tract-Based Spatial Statistics (TBSS) to determine whether WM microstructure improved, as defined by increased fractional anisotropy (FA) and/or decreased mean diffusivity (MD), after the aerobic exercise intervention. Neither FA nor MD of the cerebral WM were significantly correlated with either age or cardiovascular fitness at baseline. Whole-brain WM mean FA decreased over the intervention while mean MD showed no significant change. Longitudinal TBSS analyses revealed decreased FA in the left uncinate fasciculus, left anterior corona radiata, left inferior fronto-occipital fasciculus, and left anterior thalamic radiation. MD increased in the left forceps major, left inferior longitudinal fasciculus, and left superior longitudinal fasciculus. Results indicate that six months of aerobic exercise in healthy, sedentary older adults was not associated with improvements in FA or MD measures of cerebral WM microstructure.

A Story Grows in Rural Uganda: Studying the Effectiveness of the Storytelling/Story-Acting (STSA) Play Intervention on Ugandan Preschoolers’ School Readiness Skills

ABSTRACTChildren in the developing world are at far greater risk for emotional, psychological, and health challenges; at the same time, they have little access to clinical interventions or other support services. The intervention presented in this study is a low-cost, play-based intervention that we believed could help to address early learning and developmental challenges in preschool children in under-resourced areas, in this case, rural Uganda. This study explores the connection among storytelling, story-acting, and school readiness skills, which include emergent literacy, receptive vocabulary, and theory of mind. Ugandan children ages 3 to 5 were randomly assigned to participate in either the Storytelling/Story-Acting (STSA) play intervention (n = 63) or a story-reading activity (n = 60) for one hour twice per week for six months. With the aid of translators, all children were assessed for school readiness skills (emergent literacy, receptive vocabulary, and theory of mind) before and after the six-month intervention. Caregivers were also administered an interview that assessed their educational level, quality of life, reading aloud to target child, social support, and total possessions. Overall, participants benefited significantly from a story-reading activity with or without STSA. When examining both groups together (N = 121 post-intervention), school readiness skills significantly improved. Caregiver variables also predicted these three child outcome variables at baseline, suggesting that caregivers play a significant role in the development of their children’s school readiness skills. Implications for these findings are discussed.

NP19 A Supermarket Intervention to Promote Fruit and Vegetable Consumption Among Low-Income Families

Objective Few Americans meet national recommendations for fruit and vegetable (FV) consumption, and the high price of fresh produce is a commonly cited barrier. We conducted a randomized controlled trial to determine if a same-day, two-for-one FV coupon (Double Bucks) combined with a point-of-purchase nutrition education program (Cooking Matters) would increase FV purchases and consumption among low-income families who were regular customers of a rural Maine supermarket. Description We randomized 605 parents who regularly shopped at a Maine supermarket to a six-month intervention (Double Bucks on FV up to $10/day plus Cooking Matters) or a control arm. All participants were given a study loyalty card, which provided a 5% discount on groceries and tracked purchases during the three-month baseline and six-month intervention periods. The primary outcome was change in weekly spending on FV from baseline to follow-up in intervention and control groups. We also compared changes from baseline to follow-up in daily servings of FV among parents and children using a 135-item food frequency questionnaire. A baseline survey asked about the household's participation in the Supplemental Nutrition Assistance Program (SNAP), income, and food insecurity. Subgroup analyses compared intervention effects by SNAP participation. Evaluation At baseline, half of participants reported food insecurity. Overall, 52% were income-eligible for SNAP, and 32% participated in SNAP. Cooking Matters participation was low (11%). Compared to control, the intervention group increased weekly spending on FV by 23% ($2.23, 95% CI = $1.00, $3.46); among SNAP participants, the intervention group increased weekly spending by 43% ($2.17, 95% CI = $0.84, $3.50). Preliminary analyses revealed no overall change in FV consumption among parents or children. Conclusions and Implications Supermarket financial incentives increase household purchases of FV among SNAP and non-SNAP participants, with no evidence of increased spending on other, unhealthful foods and beverages.

FP10 In-Home Childcare Providers Participating in the Child and Adult Care Food Program (CACFP) Improve Knowledge and Nutritional Quality of Foods and Beverages Served with Nutrition Education Intervention

Objective To determine if a nutrition education intervention for in-home child care providers increased CACFP knowledge and menu adherence. Description Quasi-Experimental Study using the Healthier Childcare Environment Team Nutrition intervention group. Participants included 82 in-home child care providers from Michigan group and family day care home programs from 2016-2019. Evaluation A CACFP knowledge questionnaire and a weekly menu of foods and beverages served were collected pre and post intervention and compared with paired t-tests and Wilcoxon Signed Rank tests. Menus were coded for CACFP nutrition standard compliance by nutrition professionals. After the six-month nutrition education intervention, childcare providers’ knowledge (P = .055) of CACFP nutrition standards and motivation to improve eating and offer healthy choices increased (P = .03) from pre to post assessment. Adherence to CACFP nutrition standards for breakfast and snacks on the menu increased significantly (P Conclusions and Implications The results suggest that the Healthier Childcare Environment intervention improved the nutrition quality of foods being offered to children attending in-home childcare settings. Implementation of the Child and Adult Care Food Program nutrition standards may present challenges, especially for in home providers. Grant Year 2016

High-protein energy-restricted diets induce greater improvement in glucose homeostasis but not in adipokines comparing to standard-protein diets in early-onset diabetic adults with overweight or obesity

It has not been elucidated if an energy-restricted diet with high protein content could induce a benefit in insulin resistance in subjects with type 2 diabetes (T2DM); and if an adipose tissue functionality improvement could mediate this effect. We aimed to assess the effect of energy-restricted diets with standard (18% from total calories; SP) vshigh (35%) protein (HP), mainly coming from lean animal source, composition on glucose metabolism and adipokine concentration in overweight and obese subjects with T2DM. HOMA-IR change was the primary outcome. Six-month weight-loss intervention including 73 subjects (43.8% men, 55.6±8.37 aged and 32.8±3.67 of BMI) with T2DM that were randomized to follow one of two calorie-restricted diets with the following distribution of calories: 18% (0.75 [95%CI: 0.71-0.78] g/kg/day) protein, 52% carbohydrates and 30% fat, or 35% (1.34 [95%CI: 1.27-1.41] g/kg/day) protein, 35% carbohydrates, and 30% fat. Anthropometric, clinical, biochemical (involving leptin, RBP4 and adiponectin) and lifestyle assessments were performed. Sixty-seven participants completed the study. Weight loss homogenously decreased among diets. HOMA-IR in HP diminished 2-fold than in SP diet (P=0.023 and P=0.004at 3 and 6-months between diets). Participants following HP diet showed higher decrease in insulin, in glucose at 6-months (P=0.004) and in HbA1c at 3-months (P=0.003). RBP4 and leptin significantly decreased in both diets although no differences were found between diets. Adiponectin increased by 6.05% and 29.9% at 3-months in SP and HP diets, respectively (P=0.167), and 23.7% and 53.5% at 6-months in SP and HP diets (P=0.219). Adiponectin variation was inversely correlated with HbA1c, insulin and HOMA-IR changes at 6-months. An energy-restricted diet containing 35% of total calories coming from protein lead to a greater improvement in glucose homeostasis, indicated by HOMA-IR and fasting plasma insulin concentrations, irrespective of weight loss in subjects with prediabetes or early stages of T2DM. This effect cannot be explained by changes in plasma concentration of adipokines. The clinical trial has been registered in ClinicalTrials.gov (Identifier: NCT02559479).

An increase in plasma brain derived neurotrophic factor levels is related to n-3 polyunsaturated fatty acid efficacy in first episode schizophrenia: secondary outcome analysis of the OFFER randomized clinical trial

RationaleN−3 polyunsaturated fatty acids (n−3 PUFA) influence multiple biochemical mechanisms postulated in the pathogenesis of schizophrenia that may influence BDNF synthesis.ObjectivesA randomized placebo-controlled study was designed to compare the efficacy of a 26-week intervention composed of either 2.2 g/day of n−3 PUFA or olive oil placebo, with regard to symptom severity in first-episode schizophrenia patients. The secondary outcome measure of the study was to describe the association between n−3 PUFA clinical effect and changes in peripheral BDNF levels.MethodsSeventy-one patients aged 16–35 were enrolled in the study and randomly assigned to the following study arms: 36 to the EPA + DHA group and 35 to the placebo group. Plasma BDNF levels were assessed three times, at baseline and at weeks 8 and 26 of the intervention. BDNF levels were determined in plasma samples using Quantikine Human BDNF ELISA kit. Plasma BDNF level changes were further correlated with changes in the severity of symptoms in different clinical domains.ResultsA significantly greater increase in plasma BDNF levels was observed in the intervention compared to the placebo group (Cohen’s d = 1.54). Changes of BDNF levels inversely correlated with change in depressive symptoms assessed using the Calgary Depression Rating Scale in Schizophrenia (Pearson’s r = − 0.195; p = 0.018).ConclusionsThe efficacy of a six-month intervention with n−3 PUFA observed in first-episode schizophrenia may be related to an increase in BDNF levels, which may be triggered by the activation of intracellular signaling pathways including transcription factors such as cAMP-reactive element binding protein.

Impact of Multi-Disciplinary Care and Clinical Coach Coordinators on Participant Satisfaction and Retention in TBI Clinical Trials: A TEAM-TBI Study.

Targeted Evaluation Action and Monitoring of Traumatic Brain Injury (TEAM-TBI) is a monitored, multiple interventional research identifying clinical profiles and assigns individualized, evidence-based treatment program. The objective of the current study was to assess overall participant satisfaction of the multi-disciplinary care team and approach. Between 2014 and 2017, 90 participants completed the 4-day TEAM-TBI clinical intake evaluation resulting in individualized treatment recommendations followed by a six-month intervention phase follow-up. Inclusion criteria were: age 18-60, history of chronic TBI (>6 months post-injury) with refractory clinical sequelae at screening (Post-Concussion Symptom Scale [PCSS] score >30). A total of 85/90 (94%) participants completed the survey at baseline focusing on intake evaluation and approach; 90% of eligible participants also completed the follow-up time-point. Hundred percent of participants had a mean score of >4 across all questions at the initial time point." The multi-disciplinary care approach and individualized treatment plans of the TEAM-TBI study yielded high participant retention and satisfaction scores. The Clinical Coach component of the trial was one of the highest rated aspects of the program and was associated with participant motivation and high retention rates.

The effects of a pre-conception lifestyle intervention in women with obesity and infertility on perceived stress, mood symptoms, sleep and quality of life.

BackgroundObesity is an increasing problem worldwide and is associated with serious health risks. Obesity not only reduces physical health, but can also negatively affect levels of perceived stress, mood symptoms, sleep quality and quality of life (QoL), which may lead to further weight gain. We have previously shown that a pre-conception lifestyle intervention reduced weight and improved physical QoL in the short term. In the current study, we assessed the effects of this intervention in women with obesity and infertility on perceived stress, mood symptoms, sleep quality and QoL five years after randomization.Methods and findingsWe followed women who participated in the LIFEstyle study. This is a multi-center randomized controlled trial comparing a six-month lifestyle intervention to improve diet and increase physical activity followed by infertility treatment, versus prompt infertility treatment. Participants were 577 women with infertility between 18 and 39 years of age with a body mass index (BMI) ≥ 29 kg/m2. For the current study we measured perceived stress, mood symptoms, sleep quality and QoL in 178 women five years after randomization. T-tests and linear regression models were used to assess differences between the intervention and control groups.Five years after randomization, no differences were observed for perceived stress, mood symptoms, sleep quality and QoL between the intervention (n = 84) and control groups (n = 94). There was selective participation: women who did not participate in the follow-up had lower baseline mental QoL, and benefitted more from the intervention in terms of improved physical QoL during the original LIFEstyle intervention.ConclusionsWe found no evidence that a pre-conception lifestyle intervention improved female well-being five years after randomization.

The Modulatory Effect of Gender and Cytomegalovirus-Seropositivity on Circulating Inflammatory Factors and Cognitive Performance in Elderly Individuals.

Aging is characterized by a chronic increase in the systemic levels of inflammatory cytokines even in ostensibly healthy individuals. The drivers of age-related increase in systemic inflammation are unclear but one potential contributor may be a persistent infection with Cytomegalovirus (CMV). In this study, we characterized the inflammatory status of 161 older participants recruited to undergo a six-month training intervention. We investigated the influence of gender and CMV-seropositivity on the main inflammatory and anti-inflammatory circulating biomarkers, such as cytokines, receptor antagonist, soluble receptor, immune cells, and relevant metabolic markers. We found that both gender and CMV-seropositivity modulate circulating peripheral biomarkers, and that CMV-infection modifies associations among the latter. Moreover, we observed an interaction between CMV-serostatus and gender associations with cognitive abilities: gender differences in fluid intelligence (Gf) and working memory (WM) were noted only in CMV-negative individuals. Finally, we found that in the CMV-seronegative participants Gf, episodic memory (EM), and WM correlated negatively with pro-inflammatory tumor necrosis factor (TNF); and EM correlated positively with anti-inflammatory interleukin (IL)-10. In CMV-seropositive individuals EM and Gf correlated negatively with pro-inflammatory IL-6, while EM, Gf, and WM correlated negatively with anti-inflammatory IL-1RA. We conclude that both CMV-serostatus and gender may modulate neuroimmune factors, cognitive performance and the relationship between the two domains and should therefore be considered in comparative and interventional studies with elderly people.

The effects of extended-release injectable naltrexone and incentives for opiate abstinence in heroin-dependent adults in a model therapeutic workplace: A randomized trial

AimTo determine whether extended-release injectable naltrexone (XR-NTX), incentives for opiate abstinence, and their combination reduce opiate use compared to a usual care control and whether the combination reduces opiate use compared to either treatment alone. DesignRandomized 2 × 2 single-site controlled trial conducted from November 2012 through May 2016. After a detoxification and oral naltrexone induction, participants were assigned to a Usual Care, Abstinence Incentives, XR-NTX, or XR-NTX plus Abstinence Incentives group for a six-month intervention period. SettingA model therapeutic workplace where participants could work on automated computer programs that targeted job-skills training for 4 h every weekday for 24 weeks and earn about $10 per hour. Participants84 heroin-dependent adults who were unemployed and medically approved for naltrexone. Most participants were male (71.4%), African American (80.1%), and cocaine dependent (71.4%). MeasurementsThe primary outcome measure was the percentage of urine samples negative for opiates that were collected at once weekly assessments (24 per participant) that were not part of the intervention and for which participants were paid $10 for completing. InterventionParticipants who attended the workplace provided thrice-weekly urine samples. Abstinence Incentives participants had to provide opiate-free urine samples to maintain maximum pay. XR-NTX participants received one injection every 4 weeks and were required to take injections in order to work and to maintain maximum pay. Usual Care participants were not offered XR-NTX and opiate urinalysis results did not affect pay. FindingsA large percentage (65 of 149; 43.6%) of individuals failed the induction protocol required for randomization and to be eligible to receive XR-NTX. When missing urine samples were considered positive, there was no significant interaction between XR-NTX and Abstinence Incentives. XR-NTX plus Abstinence Incentives participants provided significantly more opiate-negative samples (81.3%, SD 39.0%) than XR-NTX participants (64.5%, SD 47.9%; aOR 10.4, 95% CI 1.3–85.5; P = .030). When urine samples were not replaced, there was a significant interaction between XR-NTX and Abstinence Incentives (aOR 77.0, 95% CI 1.3–4432;P = 0.036); XR-NTX plus Abstinence Incentives participants provided significantly more opiate-negative samples (99.6%, SD 0.1%) than XR-NTX participants (85.0%, SD 35.7%; aOR 147.6, 95% CI 6.3–3472; P = 0.002), Abstinence Incentives participants (91.9%, SD 27.3%; aOR 121.7, 95% CI 4.8–3067; P =0.004), and Usual Care participants (78.7%, SD 41.0%; aOR 233.4, 95% CI 9.4–5814; P <.001). No other group differences were significant. ConclusionXR-NTX plus incentives for opiate abstinence increased opiate abstinence, but XR-NTX alone did not. XR-NTX can promote opiate abstinence when it is combined with incentives for opiate abstinence in a model therapeutic workplace.

Data Independent Acquisition Mass Spectrometry Can Identify Circulating Proteins That Predict Future Weight Loss with a Diet and Exercise Programme.

We investigated biological determinants that would associate with the response to a diet and weight loss programme in impaired glucose regulation (IGR) people using sequential window acquisition of all theoretical fragment ion spectra (SWATH) mass spectrometry (MS), a data acquisition method which complement traditional mass spectrometry-based proteomics techniques. Ten women and 10 men with IGR underwent anthropometric measurements and fasting blood tests. SWATH MS was carried out with subsequent immunoassay of specific peptide levels. After a six-month intervention, 40% of participants lost 3% or more in weight, 45% of patients remained within 3% of their starting weight and 15% increased their weight by 3% or more. Hemoglobin A1c (HbA1C) level was reduced with weight loss with improvements in insulin sensitivity. SWATH MS on pre-intervention samples and subsequent principal component analysis identified a cluster of proteins associated with future weight loss, including insulin-like growth factor-II (IGF-II) and Vitamin D binding protein. Individuals who lost 3% in weight had significantly higher baseline IGF-II levels than those who did not lose weight. SWATH MS successfully discriminated between individuals who were more likely to lose weight and potentially improve their sensitivity to insulin. A higher IGF-II baseline was predictive of success with weight reduction, suggesting that biological determinants are important in response to weight loss and exercise regimes. This may permit better targeting of interventions to prevent diabetes in the future.

Brief telephone counselling is effective for caregivers who do not experience any major life events \u2013 caregiver-related outcomes of the German day-care study

BackgroundTo date, there has been a dearth of scientifically tested, established intervention concepts focussed on supporting informal caregivers and embedded in routine health care structures. The aim of this study was to assess effects of a brief telephone intervention for caregivers of persons with cognitive impairment (PCIs) on caregivers’ depressiveness and subjective burden.MethodsA two-arm cluster-randomised controlled intervention study was carried out at 32 German day-care centres. During the six-month intervention period, informal caregivers in the intervention group (n = 205) received counselling in three phone calls focussed on stress reduction, development of self-management strategies, and how to deal with challenging behaviours. Both the control group (n = 154) and the intervention group were free to take part in any support programmes offered by the German Health Care System (TAU). Caregivers’ subjective burden and depressiveness were measured with the Burden Scale for Family Caregivers – short version (BSFC-s) and the WHO-5 Well-Being Index (WHO-5). Outcomes were assessed by means of computer-assisted telephone interviews (CATIs) at baseline and at the end of the six-month intervention phase. Multiple regression analyses were used to show the influence of group allocation.ResultsAfter the intervention phase, group allocation was not found to significantly predict caregivers’ subjective burden or depressiveness. The baseline scores (p < 0.001) were the only significant predictors of change in both outcomes. However, sensitivity analyses for caregivers who did not experience any events that they felt were major (in a negative or positive sense) during the six months (n = 271) showed that group allocation (p < 0.05) was a significant predictor of positive change in both outcomes (BSFC-s: Δ-1.3, [− 2.4, − 0.3], Cohen’s d = 0.27; WHO-5: Δ1.5, [0.4, 2.7], Cohen’s d = 0.26). Effect sizes were highest in the subgroup of caregivers of people with mild dementia (BSFC-s: Cohen’s d = 0.43; WHO-5: Cohen’s d = 0.42).ConclusionsA “low-dose” psychoeducative telephone intervention designed to empower caregivers is effective, especially in an early stage, if the overlap between the effect of the intervention and the effect of events that are experienced as major events in the caregiver’s life is considered.Trial registrationIdentifier: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

Preconception lifestyle intervention reduces long term energy intake in women with obesity and infertility: a randomised controlled trial

BackgroundThe preconceptional period may be an optimal window of opportunity to improve lifestyle. We previously showed that a 6 month preconception lifestyle intervention among women with obesity and infertility was successful in decreasing the intake of high caloric snacks and beverages, increasing physical activity and in reducing weight in the short term. We now report the effects of the preconception lifestyle intervention on diet, physical activity and body mass index (BMI) at 5.5 years (range = 3.7–7.0 years) after the intervention.MethodsWe followed women who participated in the LIFEstyle study, a multicentre RCT in which women with obesity and infertility were assigned to a six-month lifestyle intervention program or prompt infertility treatment (N = 577). Diet and physical activity 5.5 years later were assessed with an 173-item food frequency questionnaire (N = 175) and Actigraph triaxial accelerometers (N = 155), respectively. BMI was calculated from self-reported weight and previously measured height (N = 179). Dietary intake, physical activity, and BMI in the intervention and control group were compared using multivariate regression models. Additionally, dietary intake, physical activity and BMI of women allocated to the intervention arm with successful weight loss during the intervention (i.e. BMI < 29 kg/m2 or ≥ 5% weight loss), unsuccessful weight loss and the control group were compared with ANCOVA.ResultsAlthough BMI did not differ between the intervention and control group 5.5 years after the intervention (− 0.5 kg/m2 [− 2.0;1.1]; P = 0.56), the intervention group did report a lower energy intake (− 216 kcal/day [− 417;-16]; P = 0.04). Women in the intervention arm who successfully lost weight during the intervention had a significantly lower BMI at follow-up compared to women in the intervention arm who did not lose weight successfully (− 3.4 kg/m2 [− 6.3;-0.6]; P = 0.01), and they reported a significantly lower energy intake compared to the control group (− 301 kcal [− 589;-14]; P = 0.04). Macronutrient intake, diet quality, and physical activity did not differ between the intervention and control group, irrespective of successful weight loss during the intervention.ConclusionsIn our study population, a preconception lifestyle intervention led to reduced energy intake 5.5 years later. Additionally, women allocated to the intervention group who were successful in losing weight during the intervention also had a lower BMI at follow-up. This shows the potential sustainable effect of a preconception lifestyle intervention.Trial registrationThis trial was registered on 16 November 2008 in the Dutch trial register; clinical trial registry number NTR1530.

Collective trauma among displaced populations in Northern Iraq: A case study evaluating the therapeutic interventions of the Free Yezidi Foundation

Yezidism arguably remains one of the most oppressed religions in Iraq, with the population historically confronted by many attempts at genocide. These atrocities have left many survivors displaced and affected by trauma, yet little research has been conducted on experiences of trauma among this population. In the context of an internal evaluation of the Free Yezidi Foundation’s mental health intervention in the Kurdistan Region of Iraq, 200 Yezidi women were screened at the beginning and end of a six-month mental health intervention using the World Health Organization (WHO)-5 well-being scale and the Harvard Trauma Questionnaire (HTQ). Qualitative data were obtained from sixteen focus group discussions (FGDs) among service users of the project as well as six in-depth qualitative interviews conducted with members of the project team. The results of the WHO-5 indicate a 74% increase in self-reported well-being among service users who completed the programme. According to the results of the HTQ, the baseline prevalence rate of posttraumatic stress disorder was 81.25%, which decreased to 45% upon completion of the programme. A qualitative analysis of interviews and FGDs highlighted that a significant impact on mental health were collective, multiple losses and separations (including family members who sought refuge abroad), the fact that not all Yezidi held in captivity have returned, fear of ongoing attacks and daily stressors related to poor living conditions. The results highlight the substantial impact of the political, legal and sociocultural environment on both the prevalence of trauma as well as processes of psychosocial rehabilitation. The implications for interventions include utilising socioecological frameworks for research and practice, engaging in advocacy and establishing agendas for mental health practice and psychosocial support that emphasises individual and collective self-determination. Key implications for practice Utilising eco-social frameworks for research and practice Engaging in political advocacy as part of MHPSS interventions Establishing agendas for mental health practice that emphasise individual and collective self-determination Addressing the social, cultural and political perspectives of trauma as part of MHPSS interventions Implementing interdisciplinary approaches to rehabilitation from trauma.

Efficacy of weight loss intervention can be predicted based on early alterations of fMRI food cue reactivity in the striatum

Increased fMRI food cue reactivity in obesity, i.e. higher responses to high- vs. low-calorie food images, is a promising marker of the dysregulated brain reward system underlying enhanced susceptibility to obesogenic environmental cues. Recently, it has also been shown that weight loss interventions might affect fMRI food cue reactivity and that there is a close association between the alteration of cue reactivity and the outcome of the intervention. Here we tested whether fMRI food cue reactivity could be used as a marker of diet-induced early changes of neural processing in the striatum that are predictive of the outcome of the weight loss intervention. To this end we investigated the relationship between food cue reactivity in the striatum measured one month after the onset of the weight loss program and weight changes obtained at the end of the six-month intervention. We observed a significant correlation between BMI change measured after six months and early alterations of fMRI food cue reactivity in the striatum, including the bilateral putamen, right pallidum, and left caudate. Our findings provide evidence for diet-induced early alterations of fMRI food cue reactivity in the striatum that can predict the outcome of the weight loss intervention.

Effects of Six-Month Aerobic Exercise Intervention on Sleep in Healthy Older Adults in the Brain in Motion Study: A Pilot Study.

Background: Sleep disturbances have been shown to be associated with the presence of the apolipoprotein (APOE) ɛ4 allele, the well-known genetic risk factor for late-onset sporadic Alzheimer’s disease (AD).Objective: This study quantifies the effects of a six-month aerobic exercise intervention on objective and subjective sleep quality in middle-aged to older individuals including those at increased genetic risk for late-onset sporadic Alzheimer’s disease (AD), who carry the apolipoprotein (APOE) ɛ4 risk allele.Methods: 199 sedentary men and women without significant cognitive impairments were enrolled in the Brain in Motion study, a quasi-experimental single group pre-test/post-test study with no control group. Participants completed a six-month aerobic exercise intervention and consented to genetic testing. Genotyping of APOE confirmed that 54 individuals were carriers of the ɛ4 allele. Participants’ subjective quality of sleep was assessed with the Pittsburgh Sleep Quality Index (PSQI) pre- and post-intervention. A convenience sample of participants (n = 29, APOE ɛ4+ = 7) consented to undergo two nights of in-home polysomnography (PSG) pre- and post intervention. Sleep architecture and respiratory variables were assessed.Results: The six-month aerobic exercise intervention significantly improved participants’ total PSQI score, sleep efficiency, and sleep latency in the full sample (n = 199). PSG results showed that total sleep time and sleep onset latency significantly improved over the course of the exercise intervention only in individuals who carried the APOE ɛ4 allele. These results are, however, exploratory and need to be carefully interpreted due to the rather small number of APOE ɛ4+ in the PSG subgroup.Conclusions: The six-month aerobic exercise intervention significantly improved participants’ sleep quality with beneficial effects on PSG shown in individuals at increased genetic risk for late-onset sporadic AD.