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Nutritional counseling frequency and baseline food pattern predict implementation of a high-protein and high-polyunsaturated fatty acid dietary pattern: 1-year results of the randomized NutriAct trial.
Pletsch-Borba, L, Wernicke, C, Apostolopoulou, K, Spira, D, Pohrt, A, Hornemann, S, Gerbracht, C, Pfeiffer, AFH, Spranger, J, Mai, K
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5457-5466
Abstract
BACKGROUND & AIMS NutriAct is a 36-month randomized controlled multi-center trial designed to analyze the effects of a food pattern focusing on a high-protein and high-unsaturated fatty acids (UFA) intake on healthy aging. We aimed to determine factors associated with a successful modulation of dietary pattern after 12 months in elderly participants. METHODS 502 participants were randomized into either usual care control group including dietary recommendations of the German Nutrition Society (DGE) or an intervention group, which used supplementation of rapeseed oil and specifically designed foods as well as repetitive advices to implement a food pattern based on high intake of predominantly plant proteins, UFA and fiber (NutriAct pattern). Food intake was repeatedly assessed by 3-day food records at months 0, 3, 6 and 12. Linear regression models were used to investigate determinants of basal food intake and modulation of dietary pattern during the intervention. RESULTS Food records of 242 intervention and 246 control participants (median age 66 y, 37% males) were available at baseline and were included. At baseline, high BMI was related to higher protein and saturated fatty acids and lower fiber intake. The intervention resulted in higher intake of protein, mono- and polyunsaturated fatty acids (MUFA and PUFA) and fiber, and lower carbohydrate and saturated fatty acid consumption (all p < 0.001). While individuals who were already at baseline closer to the NutriAct pattern also achieved a diet closer to the proposed pattern at month 12, the strongest absolute changes (%E) of dietary behavior were seen in those with dietary patterns further away from the proposed pattern at baseline. Attendance to nutritional sessions was crucial to change MUFA, PUFA, fiber and carbohydrate intake. CONCLUSIONS A successful modification of dietary pattern was achieved by the performed intervention within 12 months. Baseline dietary habits and attendance to nutritional sessions were substantial determinants predicting changes in dietary pattern. CLINICAL TRIAL REGISTRATION The trial was registered at German Clinical Trials Register (drks.de) as DRKS00010049.
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Food Insecurity and Weight Loss in an Underserved Primary Care Population: A Post Hoc Analysis of a Cluster Randomized Trial.
Myers, CA, Martin, CK, Apolzan, JW, Arnold, CL, Davis, TC, Johnson, WD, Katzmarzyk, PT, ,
Annals of internal medicine. 2021;(7):1032-1034
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Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.
Laborie, S, Denis, A, Horsch, A, Occelli, P, Margier, J, Morisod Harari, M, Claris, O, Touzet, S, Fischer Fumeaux, CJ
BMJ open. 2020;(1):e032910
Abstract
INTRODUCTION Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries. METHODS AND ANALYSIS Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup. ETHICS AND DISSEMINATION French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes. TRIAL REGISTRATION NUMBER NCT03156946.
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"[Repeat] testing and counseling is one of the key [services] that the government should continue providing": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.
Bannink Mbazzi, F, Namukwaya, Z, Amone, A, Ojok, F, Etima, J, Byamugisha, J, Katabira, E, Fowler, MG, Homsy, J, King, R, et al
BMC public health. 2020;(1):694
Abstract
BACKGROUND The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners. METHODS PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data. RESULTS At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples. CONCLUSION This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women. TRIAL REGISTRATION ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.
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Group Sessions or Home Visits for Early Childhood Development in India: A Cluster RCT.
Grantham-McGregor, S, Adya, A, Attanasio, O, Augsburg, B, Behrman, J, Caeyers, B, Day, M, Jervis, P, Kochar, R, Makkar, P, et al
Pediatrics. 2020;(6)
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Abstract
OBJECTIVES Poor early childhood development in low- and middle-income countries is a major public health problem. Efficacy trials have shown the potential of early childhood development interventions but scaling up is costly and challenging. Guidance on effective interventions' delivery is needed. In an open-label cluster-randomized control trial, we compared the effectiveness of weekly home visits and weekly mother-child group sessions. Both included nutritional education, whose effectiveness was tested separately. METHODS In Odisha, India, 192 villages were randomly assigned to control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions. Mothers with children aged 7 to 16 months were enrolled (n = 1449). Trained local women ran the two-year interventions, which comprised demonstrations and interactions and targeted improved play and nutrition. Primary outcomes, measured at baseline, midline (12 months), and endline (24 months), were child cognition, language, motor development, growth and morbidity. RESULTS Home visiting and group sessions had similar positive average (intention-to-treat) impacts on cognition (home visiting: 0.324 SD, 95% confidence interval [CI]: 0.152 to 0.496, P = .001; group sessions: 0.281 SD, 95% CI: 0.100 to 0.463, P = .007) and language (home visiting: 0.239 SD, 95% CI: 0.072 to 0.407, P = .009; group sessions: 0.302 SD, 95% CI: 0.136 to 0.468, P = .001). Most benefits occurred in the first year. Nutrition-education had no benefit. There were no consistent effects on any other primary outcomes. CONCLUSIONS Group sessions cost $38 per child per year and were as effective on average as home visiting, which cost $135, implying an increase by a factor of 3.5 in the returns to investment with group sessions, offering a more scalable model. Impacts materialize in the first year, having important design implications.
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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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Randomized Controlled Trial of E-Counseling for Hypertension: REACH.
Nolan, RP, Feldman, R, Dawes, M, Kaczorowski, J, Lynn, H, Barr, SI, MacPhail, C, Thomas, S, Goodman, J, Eysenbach, G, et al
Circulation. Cardiovascular quality and outcomes. 2018;(7):e004420
Abstract
BACKGROUND The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavioral counseling. METHODS AND RESULTS This multicenter double-blind randomized controlled trial included assessments at baseline, 4 months, and 12 months. Participants were 35 to 74 years of age and diagnosed with hypertension: systolic/diastolic blood pressure (BP) 130 to 180/85 to 110 mm Hg. BP was assessed by automated office measurement. E-Counseling used multimedia and interactive tools to increase motivation and skill for self-care (exercise, diet, medication adherence, and smoking cessation). Control used self-care education. Frequency of contact by our e-platform was equal for both trial arms. Primary end points were change at 4 and 12 months in systolic BP, diastolic BP, pulse pressure, total lipoprotein cholesterol, low-density lipoprotein cholesterol, total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, non-high-density lipoprotein cholesterol, and Framingham 10-year cardiovascular risk index. Intention-to-treat analysis used generalized linear models adjusted for baseline measures, sex, and medications. Among 264 participants, mean age was 57.6 years (SE, 0.6), 58% were women, with 83% on antihypertensive medications. At 12 months, e-counseling versus control evoked greater reduction in systolic BP (-10.1 mm Hg [95% confidence interval (CI), -12.5, -7.6] versus -6.0 mm Hg [95% CI, -8.5, -3.5]; P=0.02); pulse pressure (-5.2 mm Hg [95% CI, -6.9, -3.5] versus -2.7 mm Hg [95% CI, -4.5, -0.9]; P=0.04), and Framingham risk index (-1.9% [95% CI, -3.3, -0.5] versus -0.02% [95% CI, -1.2, 1.7]; P=0.02), respectively. Among males in e-counseling versus control, 12-month end points included lower diastolic BP (P=0.01), non-high-density lipoprotein cholesterol (P=0.04), total lipoprotein cholesterol (P=0.03), and a trend for total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio (P=0.07). CONCLUSIONS To our knowledge, this is the first double-blind randomized trial of e-counseling for hypertension. Added benefit for medical therapy was achieved by combining available technology with a clinically organized protocol of motivational and cognitive-behavioral counseling. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov; Unique identifier: NCT01541540.
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Designing an Internet-Based Multidomain Intervention for the Prevention of Cardiovascular Disease and Cognitive Impairment in Older Adults: The HATICE Trial.
Barbera, M, Mangialasche, F, Jongstra, S, Guillemont, J, Ngandu, T, Beishuizen, C, Coley, N, Brayne, C, Andrieu, S, Richard, E, et al
Journal of Alzheimer's disease : JAD. 2018;(2):649-663
Abstract
BACKGROUND Many dementia and cardiovascular disease (CVD) cases in older adults are attributable to modifiable vascular and lifestyle-related risk factors, providing opportunities for prevention. In the Healthy Aging Through Internet Counselling in the Elderly (HATICE) randomized controlled trial, an internet-based multidomain intervention is being tested to improve the cardiovascular risk (CVR) profile of older adults. OBJECTIVE To design a multidomain intervention to improve CVR, based on the guidelines for CVR management, and administered through a coach-supported, interactive, platform to over 2500 community-dwellers aged 65+ in three European countries. METHODS A comparative analysis of national and European guidelines for primary and secondary CVD prevention was performed. Results were used to define the content of the intervention. RESULTS The intervention design focused on promoting awareness and self-management of hypertension, dyslipidemia, diabetes mellitus, and overweight, and supporting smoking cessation, physical activity, and healthy diet. Overall, available guidelines lacked specific recommendations for CVR management in older adults. The comparative analysis of the guidelines showed general consistency for lifestyle-related recommendations. Key differences, identified mostly in methods used to assess the overall CVR, did not hamper the intervention design. Minor country-specific adaptations were implemented to maximize the intervention feasibility in each country. CONCLUSION Despite differences in CVR management within the countries considered, it was possible to design and implement the HATICE multidomain intervention. The study can help define preventative strategies for dementia and CVD that are applicable internationally.
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Longitudinal child-oriented dietary intervention: Association with parental diet and cardio-metabolic risk factors. The Special Turku Coronary Risk Factor Intervention Project.
Jaakkola, JM, Pahkala, K, Rönnemaa, T, Viikari, J, Niinikoski, H, Jokinen, E, Lagström, H, Jula, A, Raitakari, O
European journal of preventive cardiology. 2017;(16):1779-1787
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Abstract
Background The child-oriented dietary intervention given in the prospective Special Turku Coronary Risk Factor Intervention Project (STRIP) has decreased the intake of saturated fat and lowered serum cholesterol concentration in children from infancy until early adulthood. In this study, we investigated whether the uniquely long-term child-oriented intervention has affected also secondarily parental diet and cardio-metabolic risk factors. Methods The STRIP study is a longitudinal, randomized infancy-onset atherosclerosis prevention trial continued from the child's age of 8 months to 20 years. The main aim was to modify the child's diet towards reduced intake of saturated fat. Parental dietary intake assessed by a one-day food record and cardio-metabolic risk factors were analysed between the child's ages of 9-19 years. Results Saturated fat intake of parents in the intervention group was lower [mothers: 12.0 versus 13.9 daily energy (E%), p < 0.0001; fathers: 12.5 versus 13.9 E%, p < 0.0001] and polyunsaturated fat intake was higher (mothers: 6.1 versus 5.4 E%, p < 0.0001; fathers: 6.3 versus 5.9 E%, p = 0.0003) compared with the control parents. Maternal total and low-density lipoprotein cholesterol concentrations were lower in the intervention compared with the control group (mean ± SE 5.02 ± 0.04 versus 5.14 ± 0.04 mmol/l, p = 0.04 and 3.19 ± 0.04 versus 3.30 ± 0.03 mmol/l, p = 0.03, respectively). Paternal cholesterol values did not differ between the intervention and control groups. Other cardio-metabolic risk factors were similar in the study groups. Conclusions Child-oriented dietary intervention shifted the dietary fat intakes of parents closer to the recommendations and tended to decrease total and low-density lipoprotein cholesterol in the intervention mothers. Dietary intervention directed to children benefits also parents.