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The Effect of Dietary Intervention Along with Nutritional Education on Reducing the Gastrointestinal Side Effects Caused by Chemotherapy Among Women with Breast Cancer.
Abdollahi, R, Najafi, S, Razmpoosh, E, Shoormasti, RS, Haghighat, S, Raji Lahiji, M, Chamari, M, Asgari, M, Cheshmazar, E, Zarrati, M
Nutrition and cancer. 2019;(6):922-930
Abstract
Gastrointestinal (GI) side effects caused by chemotherapy in women with breast cancer are common but poorly understood which might be controlled by nutritional intervention. Thus, the major aim of this study was to assess the effect of dietary intervention along with nutritional education on reducing these side effects. The present study is a single-center, single-controlled, and randomized trial. A total of 150 patients with breast cancer undergoing chemotherapy were randomly assigned into intervention group to receive dietary intervention and nutritional education (n = 73) or control group (n = 67) for 10 weeks, after their three sessions of chemotherapy. The primary endpoint was the GI symptoms after each session of chemotherapy that were measured by a designed questionnaire based on ROMIII questionnaire. The severity of GI side effects in the dietary intervention along with nutritional education was decreased significantly in the third session of chemotherapy compared to the first session, which include reflux disorder (P = 0.05), anorexia (P < 0.001), nausea (P = 0.002), constipation (P < 0.001), and diarrhea (P < 0.001). Moreover, significant reductions were observed in the severity of GI side effects in the intervention group compared to control group after the third session (P < 0.001). After adjusting the analysis for baseline values including age, job, education level, weight, and body mass index, significant changes were observed for GI side effects in the intervention group compared to the control group (P < 0.001). This study showed beneficial effects of individualized dietary intervention along with nutritional education on reducing diarrhea, constipation, vomiting, and nausea in women with breast cancer during the chemotherapy.
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The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.
Berger, MB, Steinberg, DM, Askew, S, Gallis, JA, Treadway, CC, Egger, JR, Kay, MC, Batch, BC, Finkelstein, EA, DeVries, A, et al
BMC public health. 2019;(1):596
Abstract
BACKGROUND For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina. METHODS Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network. DISCUSSION For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care. TRIALS REGISTRATION NCT03003403 . Registered December 28, 2016.
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Prevention of Metabolic Syndrome by Telephone-Delivered Lifestyle Intervention in a Real-World Setting: Sub-Analysis of a Cluster-Randomized Trial.
Sakane, N, Kotani, K, Suganuma, A, Takahashi, K, Sato, J, Suzuki, S, Izumi, K, Kato, M, Noda, M, Nirengi, S, et al
Metabolic syndrome and related disorders. 2019;(7):355-361
Abstract
Background: Evidence of the long-term benefits of telephone-delivered lifestyle interventions is limited. This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. Methods: Our subjects were participants in the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a prospective, cluster-randomized controlled trial designed to investigate whether goal-focused lifestyle coaching over the telephone can effectively reduce the incidence of type 2 diabetes development in high-risk individuals in a primary health care setting. We extracted 753 and 844 J-DOIT1 participants from the intervention and controls arms, respectively, who had IFG but did not meet the MetS criteria at baseline. The intervention arm received goal-focused lifestyle support delivered by health care providers via telephone over a 1-year period. The endpoint was the development of incident MetS, defined based on the Adult Treatment Panel III criteria modified for Japan. Results: During the median follow-up period of 4.9 years, 8.0% of the intervention arm and 12.0% of the control arm developed MetS. Overall, the hazard ratio (HR) for the development of MetS was 0.75 [95% confidence interval (CI), 0.52-1.09; P = 0.14] in the intervention arm. However, the HR in overweight or obese [body mass index (BMI) ≥23 kg/m2] individuals was significantly reduced to 0.63 (95% CI, 0.41-0.95; P = 0.029), but not in lean (BMI <23 kg/m2) individuals. Conclusion: Telephone-delivered lifestyle intervention effectively reduced the incidence of MetS in overweight and obese subjects in a real-world setting. Clinical trial registration number: UMIN000000662 (registered March 30, 2007; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000798).
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Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS.
Wills, AM, Garry, J, Hubbard, J, Mezoian, T, Breen, CT, Ortiz-Miller, C, Nalipinski, P, Sullivan, S, Berry, JD, Cudkowicz, M, et al
BMC neurology. 2019;(1):104
Abstract
BACKGROUND Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. METHODS In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse ("standard care"), counseling by a registered dietitian (RD) ("in-person"), or counseling supported by a mHealth app ("mHealth"). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. RESULTS A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p = 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake was not different among the three arms. Overall weight was stable across all three groups. QOL scores in the mHealth arm were stable over 3 months (0.3 points, 95% CI: - 1.7, 2.2) compared to worsening in standard care (- 2.1 points, 95% CI: - 4.0, - 0.2, p = 0.09 vs. mHealth), but all scores declined by 6 months. ALSFRS-R total scores declined by an average of - 2.6 points (95% CI: - 5.1, - 0.1) over 6 months in the mHealth arm (p = 0.13 vs. standard care) compared to - 5.8 points (95% CI: - 8.2, - 3.4, p = 0.74 vs. standard care) in the in-person and - 5.2 points (95% CI: - 7.6, - 2.9) in the standard care arm. CONCLUSIONS Nutritional counseling by a registered dietitian (with or without support by an mHealth app) is safe but did not maintain weight significantly better than standard care in ALS patients. TRIAL REGISTRATION https://clinicaltrials.gov/ identifier NCT02418546. Registered April 16, 2015.
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Exercise Is Medicine: Primary Care Counseling on Aerobic Fitness and Muscle Strengthening.
Crump, C, Sundquist, K, Sundquist, J, Winkleby, MA
Journal of the American Board of Family Medicine : JABFM. 2019;(1):103-107
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Abstract
Patient counseling on physical fitness remains underutilized in primary care, despite its clinical and cost effectiveness. Most counseling interventions have focused on aerobic activity and neglected another vital component of physical fitness, muscle strengthening, which has recently been shown to be independently protective against cardiometabolic diseases and premature mortality. This article reviews the latest scientific evidence and makes recommendations toward a more comprehensive approach for promoting physical fitness in primary care. Given the high prevalence and wide-ranging health impacts of physical inactivity, counseling on physical fitness should be a standard part of wellness promotion and disease prevention and treatment for all patients. Interventions that include muscle strengthening will have a significantly greater impact on health outcomes than those focused on aerobic fitness alone. Counseling to promote both aerobic fitness and muscle strengthening is indicated for all patients, irrespective of body weight, and should begin early in life and continue across the life course.
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Counselling for physical activity, life-space mobility and falls prevention in old age (COSMOS): protocol of a randomised controlled trial.
Edgren, J, Karinkanta, S, Rantanen, T, Daly, R, Kujala, UM, Törmäkangas, T, Sievänen, H, Kannus, P, Heinonen, A, Sipilä, S, et al
BMJ open. 2019;(9):e029682
Abstract
INTRODUCTION The most promising way to promote active life years in old age is to promote regular participation in physical activity (PA). Maintaining lower extremity muscle function with good balance has been associated with fewer falls and the need of help from others. This article describes the design and intervention of a randomised controlled trial (RCT) investigating the effectiveness of a health and PA counselling programme on life-space mobility and falls rates in community-dwelling older adults at the Health Kiosk and/or Service Centre. METHODS AND ANALYSIS Community-dwelling men and women (n=450) aged 65 years and over with early phase mobility limitation will be recruited to a 24-month RCT with a 24-month follow-up. Participants will be randomly allocated into either a health and PA counselling group (intervention) or relaxation group (control intervention). All participants will receive five group specific face-to-face counselling sessions and 11 phone calls. The counselling intervention will include individualised health counselling, strength and balance training, and guidance to regular PA. The control group will receive relaxation exercises. Outcomes will be assessed at baseline, 12, 24 and 48 months. Primary outcomes are average life-space mobility score and falls rates. Life-space mobility will be assessed by a validated questionnaire. Falls rates will be recorded from fall diaries. Secondary outcomes are data on fall-induced injuries and living arrangements, number of fallers, fracture risk, mean level of PA, physical performance, quality of life, mood, cognition, balance confidence and fear of falling. Data will be analysed using the intention-to-treat principle. Cost-effectiveness of the programme will be analysed. Ancillary analyses are planned in participants with greater adherence. ETHICS AND DISSEMINATION Ethical approval was obtained from the Ethics Committee of the Tampere University Hospital (R15160). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conferences. TRIAL REGISTRATION ISRCTN65406039; Pre-results.
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Early rehabilitation of cancer patients-An individual randomized stepped-care stress-management intervention.
Arving, C, Assmus, J, Thormodsen, I, Berntsen, S, Nordin, K
Psycho-oncology. 2019;(2):301-308
Abstract
OBJECTIVE To evaluate the effects of an individual stepped-care stress-management intervention for cancer patients on cancer-related stress reactions (intrusion/avoidance), and secondarily on psychological distress (anxiety/depression) and emotional reactivity (impatience/hostility). METHODS Consecutively 291 cancer patients were included in a randomized controlled intervention study. Patients randomized to the intervention who did not report clinically significant stress levels (n = 72) after the first counseling session participated in only one counseling session and a follow-up (Step 1). The remaining patients (n = 66) received an additional three to eight sessions, depending on individual needs (Step 2). The intervention used techniques derived from cognitive behavioral therapy (CBT) such as daily registration of events and behaviors as well as scheduled behavioral and physical activity, along with short relaxation exercises. The intervention was completed within 26 weeks of inclusion. The Impact of Event Scale, Hospital Anxiety and Depression Scale, and Everyday Life Stress Scale were used to evaluate effects for 2 years. RESULTS The linear mixed effects model analysis showed a difference between the randomization groups in favor of the intervention for avoidance and intrusion after the first 6 weeks (P = 0.001 and P = 0.003) and for emotional reactivity after 17 weeks (P = 0.007). There were no differences in psychological distress. Decreases in cancer-related stress reactions and depression were noted for the Step 2 intervention. CONCLUSIONS An individual stepped-care stress-management intervention for cancer patients, performed by specially educated health professionals using techniques derived from CBT, seems beneficial for cancer patients and may therefore be a realistic complement to routine cancer care.
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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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Pilot randomized trial of a telephone-delivered physical activity and weight management intervention for individuals with lower extremity amputation.
Littman, AJ, Haselkorn, JK, Arterburn, DE, Boyko, EJ
Disability and health journal. 2019;(1):43-50
Abstract
BACKGROUND Obesity and inactivity are common and burdensome for people with lower extremity amputation (LEA). The extent to which home-based physical activity/weight management programs are effective and safe for people with LEA is unknown. Translating effective interventions for understudied disability groups is needed. OBJECTIVE To test the feasibility, acceptability, and safety of a weight management and physical activity intervention and obtain preliminary efficacy estimates for changes in weight, body composition, and physical functioning. METHODS Eligibility criteria included: LEA ≥1 year prior, 18-69 years of age, overweight or obese and living in the Seattle area. The intervention arm received self-monitoring tools (e.g., pedometer, scale) and written materials, a single exercise counseling home visit by a physical therapist, and up to 11 telephone calls from a health coach over 20 weeks that involved motivational interviewing to set specific, attainable, and measurable goals. The self-directed control group received the same tools and materials but no home visit or coaching calls. RESULTS Nineteen individuals consented to participate, 15 were randomized (mean age = 56, 73% male, 80% transtibial amputation) and 11 completed 20-week follow-up assessments. The intervention was acceptable and safe. Coached participants had greater decreases in waist circumference (mean difference between groups over 20 weeks, baseline values carried forward: -4.3 cm, 95% CI -8.2, -0.4, p = 0.03) and fat mass (-2.1 kg, 95% CI -3.8, -0.4, p = 0.02). CONCLUSIONS The home-based intervention was promising in terms of efficacy, safety and acceptability. Inclusion of multiple trial centers and increased use of technology may facilitate recruitment and retention.
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Improving oncology nurses' knowledge, self-confidence, and self-efficacy in nutritional assessment and counseling for patients with cancer: A quasi-experimental design.
Sharour, LA
Nutrition (Burbank, Los Angeles County, Calif.). 2019;:131-134
Abstract
OBJECTIVE Our objective was to assess the effectiveness of a structured educational program on improving oncology nurses' knowledge, self-confidence, and self-efficacy in nutritional assessment and counseling for patients with cancer. METHODS A pretest-posttest quasi-experimental design was used. A sample of 60 nurses from oncology units participated as an experimental group (n = 30) and a control group (n = 30). The participants completed a knowledge test before completing the educational program. Self-confidence and self-efficacy also were assessed pre- and postintervention. RESULTS There was a significant difference between the experimental (mean [M] = 26.00, SD = 8.00) and control (M = 10.00, SD = 3.75) groups regarding knowledge after the interventional sessions (t = -16.00, P = 0.001). Furthermore, the results indicated a significant difference (t = -24.00, P = 0.001) between the experimental group (M = 60.50, SD = 13.10) and the control group (M = 36.50, SD = 7.60) regarding self- confidence in managing cancer patients. Finally, there was a significant difference between the experimental group (M = 33.50, SD = 3.10) and control group (M = 23.25, SD = 2.75) regarding self-efficacy (t = -10.25, P = 0.001). CONCLUSIONS The educational program improved the oncology nurses' knowledge, self-confidence, and self-efficacy in relation to nutritional assessment and counseling. Improving nurses' competencies will improve the quality of care provided to the patients and patient health outcomes.