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Effect of a 30-Month Health-Promoting Program on the Prevalence of Cardiovascular Risk Factors in Patients With First Episode Schizophrenia.
Søgaard, HJ, Højlund, M, Elliott, A, Viuff, AG, Vandborg, K, Viuff, J, Munk-Jørgensen, P, Hjorth, P
American journal of therapeutics. 2020;(5):e439-e449
Abstract
BACKGROUND Lifestyle interventions aimed at reducing cardiovascular risk factors in patients with first-episode schizophrenia (FES) have shown modest efficacy, probably owing to a short observation period and the presumption of linear trajectories of cardiovascular risk factors. STUDY QUESTION How prevalent are abnormal cardiovascular values in patients with FES and how do cardiovascular risk factors develop during a 30-month program? STUDY DESIGN A 30-month naturalistic longitudinal study of 136 consecutively referred patients with FES from 2 outpatient clinics. The health-promoting program consisted of individual guidance, group sessions, and normal treatment and care. MEASURES AND OUTCOMES The prevalence of abnormal cardiovascular risk factors (body mass index, waist circumference (WC), body fat percentage, systolic and diastolic blood pressure, pulse, total cholesterol, high- and low-density lipoproteins, triglycerides, mean glucose, and visceral adiposity index) was estimated at index. The cardiovascular risk factor trajectories were analyzed with longitudinal mixed-effect models. RESULTS The patient with FES showed elevated cardiovascular risk factors at index. Thus, 56.8% of the patients were overweight in different grades and 50.4% had increased WC. A total of 81.8% had high level of body fat and hypertension prevalence with only 20% with normal blood pressure. Important changes during the intervention period were that the risk factors weight and WC were increasing the first 581 and 646 days, after which they decreased. Almost all cardiovascular risk factors worsened initially, improving after 1-2 years. CONCLUSIONS Patients with FES show increases in cardiovascular risk factors at index. Short observation periods and the presumption of linear trajectories may indicate that the effect of health-promoting programs is ineffective, as the effects are curvilinear and improvements appear only after 1 year. The implication clinically is the importance of a long intervention period regarding lifestyle modifications to ascertain improvement among patients with FES.
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Effects of a lifestyle intervention in routine care on prenatal physical activity - findings from the cluster-randomised GeliS trial.
Hoffmann, J, Günther, J, Geyer, K, Stecher, L, Rauh, K, Kunath, J, Meyer, D, Sitzberger, C, Spies, M, Rosenfeld, E, et al
BMC pregnancy and childbirth. 2019;(1):414
Abstract
BACKGROUND Excessive gestational weight gain (GWG) is associated with an increased risk of pregnancy and obstetric complications. The "healthy living in pregnancy" (GeliS) study was performed in a routine care setting with the aim of limiting excessive GWG. The purpose of this secondary analysis is to evaluate the effect of the intervention on physical activity (PA) behaviour and to assess the impact of PA intensities on GWG. METHODS The cluster-randomised, multicentre GeliS trial was performed in a routine care setting alongside scheduled prenatal visits. Pregnant women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 were either assigned to the control group receiving usual care or to the intervention group. Participants in the intervention group attended three antenatal counselling sessions on diet and PA and one additional postpartum session. Data on PA behaviour were collected twice, before the end of the 12th (baseline) and after the 29th week of gestation using the Pregnancy Physical Activity Questionnaire. RESULTS PA data were available for 1061 (93%) participants in the intervention and 1040 (93%) in the control group. Women in the intervention group reported significant improvements in the levels of total PA (p < 0.001), total PA of light intensity and above (p < 0.001), moderate-intensity (p = 0.024) and vigorous-intensity activities (p = 0.002) as well as sport activities (p < 0.001) in late pregnancy compared to the control group. The proportion of women meeting the international PA recommendations in late pregnancy was significantly higher in the intervention (64%) versus the control group (49%, p < 0.001). Activities of light-intensity and above (p = 0.006), light-intensity (p = 0.002) and vigorous-intensity (p = 0.014) in late pregnancy were inversely associated with total GWG. CONCLUSION We found significant evidence of improvements in the PA pattern of pregnant women receiving lifestyle counselling within the framework of routine care. Most PA intensities were inversely associated with total GWG which indicates that PA across different intensities should be promoted. TRIAL REGISTRATION NCT01958307, ClinicalTrials.gov, retrospectively registered 9 October, 2013.
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Translating a "Stand Up and Move More" intervention by state aging units to older adults in underserved communities: Protocol for a randomized controlled trial.
Crombie, KM, Leitzelar, BN, Almassi, NE, Mahoney, JE, Koltyn, KF
Medicine. 2019;(27):e16272
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Abstract
INTRODUCTION As aging is associated with functional decline, preventing functional limitations and maintaining independence throughout later life has emerged as an important public health goal. Research indicates that sedentary behavior (prolonged sitting) is associated with functional loss and diminished ability to carry out activities of daily living. Despite many efforts to increase physical activity, which can be effective in countering functional loss, only an estimated 8% of older adults meet national physical activity guidelines. Thus, shifting the focus to reducing sitting time is emerging as a potential new intervention strategy but little research has been conducted in this area. With community support and funding, we developed and pilot tested a 4-week "Stand Up and Move More" intervention and found decreases in sedentary behavior, increases in physical activity, and improvements in mobility and vitality in a small sample of older adults. The purpose of this project is to expand upon these pilot results and examine the effectiveness and feasibility of translating a "Stand Up and Move More" intervention by State Aging Units to older adults in underserved communities. Eighty older adults from 4 counties across Wisconsin predominantly made up of rural older adults and older African American adults are randomly assigned to intervention (n = 40) or wait-list control (n = 40) groups. The intervention consists of 4 weekly sessions plus a refresher session at 8 weeks, and is delivered by community partners in each county. The sessions are designed to elicit ideas from older adults regarding how they can reduce their sitting time, help them set practical goals, develop action plans to reach their goals, and refine their plans across sessions to promote behavior change. Sedentary behavior, physical activity levels, functional performance, and health-related quality of life are assessed before and after the intervention to examine the effectiveness of the program. Feasibility of implementing the program by our community partners is assessed via semi-structured interviews. Strengths of this project include strong community collaborations and a high need given that the older adult population is projected to increase substantially in the next 15 years. CONCLUSION This project will provide an important step in developing effective strategies for maintaining independence in older adults through determining the feasibility and impact of a community-based intervention to break up sitting time.
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Variants in APOA5 and ADIPOQ Moderate Improvements in Metabolic Syndrome during a One-Year Lifestyle Intervention.
Lowry, DE, Fenwick, PH, Roke, K, Jeejeebhoy, K, Dhaliwal, R, Brauer, P, Royall, D, Tremblay, A, Klein, D, Mutch, DM
Lifestyle genomics. 2018;(2):80-89
Abstract
BACKGROUND Metabolic syndrome (MetS) comprises a cluster of risk factors including central obesity, hypertension, dyslipidemia, and impaired glucose homeostasis. Lifestyle interventions that promote improvements in diet quality and physical activity represent a first line of therapy for MetS. However, varying responses to lifestyle interventions are well documented and may be partially explained by underlying genetic differences. The aim of this study was to investigate if variants in genes previously associated with MetS influence the magnitude of change in MetS risk during a 1-year lifestyle intervention. METHODS The present study used data collected from the Canadian Health Advanced by Nutrition and Graded Exercise study cohort (n = 159 men and women) to investigate the effect of 17 candidate single nucleotide polymorphisms (SNPs) on response to a 1-year lifestyle intervention. Associations between SNPs and the continuous MetS (cMetS) score, as well as individual MetS components, were examined. RESULTS Reductions in cMetS score at both 3 months and 1 year were significantly associated with 2 variants: rs662799 (A/G) in apolipoprotein A5 (APOA5) and rs1501299 (G/T) in adiponectin (ADIPOQ). Individuals carrying a minor T allele in rs1501299 experienced a greater reduction in cMetS score at both 3 months and 1 year, whereas major allele AA homozygotes in rs662799 experienced greater reductions in cMetS score during the intervention. No associations were identified between the aforementioned SNPs and individual components of MetS. Both un-weighted and weighted genetic risk scores (GRS) using these 2 SNPs revealed that individuals carrying none of the risk alleles experienced significantly greater reductions in cMetS score after 1 year. CONCLUSIONS The findings from the current study suggest that individuals with certain genotypes may benefit more from a lifestyle intervention for MetS and that specific variants, either independently or as part of a GRS, could be used as a nutrigenomic tool to tailor the intervention to reduce the risk of MetS.
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INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial.
Bogaerts, A, Ameye, L, Bijlholt, M, Amuli, K, Heynickx, D, Devlieger, R
BMC pregnancy and childbirth. 2017;(1):154
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.
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A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity.
Erickson, ZD, Kwan, CL, Gelberg, HA, Arnold, IY, Chamberlin, V, Rosen, JA, Shah, C, Nguyen, CT, Hellemann, G, Aragaki, DR, et al
Journal of general internal medicine. 2017;(Suppl 1):32-39
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BACKGROUND Weight gain and other metabolic sequelae of antipsychotic medications can lead to medication non-adherence, reduced quality of life, increased costs, and premature mortality. Of the approaches to address this, behavioral interventions are less invasive, cost less, and can result in sustained long-term benefits. OBJECTIVE We investigated behavioral weight management interventions for veterans with mental illness across four medical centers within the Veterans Affairs (VA) Healthcare System. DESIGN We conducted a 12-month, multi-site extension of our previous randomized, controlled study, comparing treatment and control groups. PARTICIPANTS Veterans (and some non-veteran women) diagnosed with mental illness, overweight (defined as having a BMI over 25), and required ongoing antipsychotic therapy. INTERVENTIONS One group received "Lifestyle Balance" (LB; modified from the Diabetes Prevention Program) consisting of classes and individual nutritional counseling with a dietitian. A second group received less intensive "Usual Care" (UC) consisting of weight monitoring and provision of self-help. MAIN MEASURES Participants completed anthropometric and nutrition assessments weekly for 8 weeks, then monthly. Psychiatric, behavioral, and physical assessments were conducted at baseline and months 2, 6, and 12. Metabolic and lipid laboratory tests were performed quarterly. KEY RESULTS Participants in both groups lost weight. LB participants had a greater decrease in average waist circumference [F(1,1244) = 11.9, p < 0.001] and percent body fat [F(1,1121) = 4.3, p = 0.038]. Controlling for gender yielded statistically significant changes between groups in BMI [F(1,1246) = 13.9, p < 0.001]. Waist circumference and percent body fat decreased for LB women [F(1,1243) = 22.5, p < 0.001 and F(1,1221) = 4.8, p = 0.029, respectively]. The majority of LB participants kept food and activity journals (92%), and average daily calorie intake decreased from 2055 to 1650 during the study (p < 0.001). CONCLUSIONS Behavioral interventions specifically designed for individuals with mental illness can be effective for weight loss and improve dietary behaviors. "Lifestyle Balance" integrates well with VA healthcare's patient-centered "Whole Health" approach. ClinicalTrials.gov identifier NCT01052714.
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Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial.
Westland, H, Bos-Touwen, ID, Trappenburg, JC, Schröder, CD, de Wit, NJ, Schuurmans, MJ
Trials. 2017;(1):79
Abstract
BACKGROUND Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. METHODS/DESIGN A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction. DISCUSSION To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016.
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Working mechanisms of a behavioural intervention promoting physical activity in persons with subacute spinal cord injury.
Nooijen, CF, Stam, HJ, Schoenmakers, I, Sluis, TA, Post, MW, Twisk, JW, , , van den Berg-Emons, RJ
Journal of rehabilitation medicine. 2016;(7):583-8
Abstract
OBJECTIVE In order to unravel the working mechanisms that underlie the effectiveness of a behavioural intervention promoting physical activity in persons with subacute spinal cord injury, the aim of this study was to assess the mediating effects of physical and psychosocial factors on the intervention effect on physical activity. DESIGN Randomized controlled trial. SETTING Four rehabilitation centres in the Netherlands. SUBJECTS Thirty-nine persons with subacute spinal cord injury. INTERVENTION Behavioural intervention promoting an active lifestyle, based on motivational interviewing. The intervention involved a total of 13 individual sessions beginning 2 months before and ending 6 months after discharge from initial inpatient rehabilitation. MAIN MEASURES The potential mediating effects of fatigue, pain, depression, illness cognition, exercise self-efficacy, coping and social support on the effect of the behavioural intervention on objectively measured physical activity (B = 0.35 h, p < 0.01) were studied. Measurements were performed at baseline, discharge, 6 months and 1 year after discharge. RESULTS No single factor was found that strongly mediated the effect of the behavioural intervention on physical activity; however, multiple factors could partly explain the effect. Mediating effects greater than 10% were found for proactive coping (17.6%), exercise self-efficacy (15.9%), pain disability (15.3%) and helplessness (12.5%). DISCUSSION Proactive coping (the ability to anticipate and deal with potential threats before they occur), exercise self-efficacy (self-confidence with respect to performing exercise and daily physical activities), pain disability (interference by pain of daily activities) and helplessness (emphasizing the aversive meaning of the disease) are important concepts in interventions promoting physical activity in persons with subacute spinal cord injury.
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Effects of the lifestyle intervention program GLICEMIA in people at risk for type 2 diabetes: a cluster-randomized controlled trial.
Schmiedel, K, Mayr, A, Fießler, C, Schlager, H, Friedland, K
Diabetes care. 2015;(5):937-9
Abstract
OBJECTIVE The aim of this study was to assess the efficacy of a 12-month prevention program conducted in 42 community pharmacies in reducing the risk for diabetes. RESEARCH DESIGN AND METHODS In a cluster-randomized controlled trial in 1,092 participants, mean change in the risk for diabetes (indicated by the Finnish Diabetes Risk Score [FINDRISC]) between intervention and control groups was calculated. In the intervention program GLICEMIA, three appointments with individual counseling and five educational group sessions were combined, whereas in the control group, only information about the participants' health was obtained in three assessments. RESULTS After adjusting for cluster structure and differences in baseline characteristics, improvement in FINDRISC in the intervention group was 0.74 points (95% CI 0.42-1.04) above the control group. CONCLUSIONS The GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over 1 year.
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Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.
Weiss, DM, Casten, RJ, Leiby, BE, Hark, LA, Murchison, AP, Johnson, D, Stratford, S, Henderer, J, Rovner, BW, Haller, JA
JAMA ophthalmology. 2015;(9):1005-12
Abstract
IMPORTANCE African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. OBJECTIVE To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. DESIGN, SETTING, AND PARTICIPANTS Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. INTERVENTIONS Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. MAIN OUTCOMES AND MEASURES The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. RESULTS More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P < .001). Overall, participants in the behavioral activation for diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P < .001). The intervention had no short-term effect on secondary outcomes of hemoglobin A1c levels, depression, or the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up. CONCLUSIONS AND RELEVANCE Behavioral activation for diabetic retinopathy prevention significantly increased rates of DFEs in older African American individuals with diabetes mellitus. Behavioral interventions may have the potential to positively affect screening for diabetic retinopathy in at-risk populations. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01179555.