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Evaluating the Findings of the IMPACT-C Randomized Clinical Trial to Improve COVID-19 Vaccine Coverage in Skilled Nursing Facilities.
Berry, SD, Goldfeld, KS, McConeghy, K, Gifford, D, Davidson, HE, Han, L, Syme, M, Gandhi, A, Mitchell, SL, Harrison, J, et al
JAMA internal medicine. 2022;(3):324-331
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IMPORTANCE Identifying successful strategies to increase COVID-19 vaccination among skilled nursing facility (SNF) residents and staff is integral to preventing future outbreaks in a continually overwhelmed system. OBJECTIVE To determine whether a multicomponent vaccine campaign would increase vaccine rates among SNF residents and staff. DESIGN, SETTING, AND PARTICIPANTS This was a cluster randomized trial with a rapid timeline (December 2020-March 2021) coinciding with the Pharmacy Partnership Program (PPP). It included 133 SNFs in 4 health care systems across 16 states: 63 and 70 facilities in the intervention and control arms, respectively, and participants included 7496 long-stay residents (>100 days) and 17 963 staff. INTERVENTIONS Multicomponent interventions were introduced at the facility level that included: (1) educational material and electronic messaging for staff; (2) town hall meetings with frontline staff (nurses, nurse aides, dietary, housekeeping); (3) messaging from community leaders; (4) gifts (eg, T-shirts) with socially concerned messaging; (5) use of a specialist to facilitate consent with residents' proxies; and (6) funds for additional COVID-19 testing of staff/residents. MAIN OUTCOMES AND MEASURES The primary outcomes of this study were the proportion of residents (from electronic medical records) and staff (from facility logs) who received a COVID-19 vaccine (any), examined as 2 separate outcomes. Mixed-effects generalized linear models with a binomial distribution were used to compare outcomes between arms, using intent-to-treat approach. Race was examined as an effect modifier in the resident outcome model. RESULTS Most facilities were for-profit (95; 71.4%), and 1973 (26.3%) of residents were Black. Among residents, 82.5% (95% CI, 81.2%-83.7%) were vaccinated in the intervention arm, compared with 79.8% (95% CI, 78.5%-81.0%) in the usual care arm (marginal difference 0.8%; 95% CI, -1.9% to 3.7%). Among staff, 49.5% (95% CI, 48.4%-50.6%) were vaccinated in the intervention arm, compared with 47.9% (95% CI, 46.9%-48.9%) in usual care arm (marginal difference: -0.4%; 95% CI, -4.2% to 3.1%). There was no association of race with the outcome among residents. CONCLUSIONS AND RELEVANCE A multicomponent vaccine campaign did not have a significant effect on vaccination rates among SNF residents or staff. Among residents, vaccination rates were high. However, half the staff remained unvaccinated despite these efforts. Vaccination campaigns to target SNF staff will likely need to use additional approaches. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04732819.
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Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3.
Lugones-Sánchez, C, Recio-Rodríguez, JI, Menéndez-Suárez, M, Saz-Lara, A, Ramirez-Manent, JI, Sánchez-Calavera, MA, Gómez-Sánchez, L, Rodríguez-Sánchez, E, García-Ortiz, L, Evident Investigators Group,
Nutrients. 2022;(2)
Abstract
A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (-30.8; 95% CI -59.9, -1.7) and full-fat dairies (-23.3; 95% CI -42.8, -3.8) and increased the intake of wholemeal bread (3.3; 95% CI -6.7, 13.3) and whole-grain cereals (3.4; 95% CI -6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.
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Personal Activity Intelligence e-Health Program in People with Type 2 Diabetes: A Pilot Randomized Controlled Trial.
Coombes, JS, Keating, SE, Mielke, GI, Fassett, RG, Coombes, BK, O'Leary, KP, Cox, ER, Burton, NW
Medicine and science in sports and exercise. 2022;(1):18-27
Abstract
INTRODUCTION Innovative strategies are needed to enable people with type 2 diabetes (T2D) to self-manage physical activity (PA). Personal Activity Intelligence (PAI) is a new metric that uses the heart rate response to PA to inform the user as to whether they are doing enough PA to reduce the risk of premature mortality. The PAI score reflects PA over the previous 7 d with the goal to maintain a score ≥100. The aim of this study was to investigate the feasibility, acceptability, and efficacy of the PAI e-Health Program in people with T2D. METHODS Thirty participants with T2D who were not meeting PA guidelines were randomly assigned to 12 wk of either 1) PAI e-Health Program or 2) PA attention control. The PAI e-Health Program consisted of receiving a wrist-worn heart rate monitor and an app with the PAI metric, and attending 4 × 2 h·wk-1 sessions of exercise and counseling. Feasibility and acceptability of the program were evaluated by achievement of a PAI score ≥100 and participant feedback. Efficacy was determined from changes in glycemic control, cardiorespiratory fitness, exercise capacity (time-on-test), body composition, sleep time, and health-related quality of life. RESULTS Program participants in the PAI e-Health Program had a mean ± SD PAI score of 119.7 ± 60.6 and achieved ≥100 PAI on 56.4% of the days. The majority of participants (80%) intended to continue to use PAI monitoring. Compared with control, the PAI group significantly improved their exercise capacity (mean difference, 95% confidence interval) (63 s, 17.9-108.0 s), sleep time (67.2 min, 7.2-127.1 min), total percent body fat (-1.3%, -2.6% to -0.1%), and gynoid fat percent (-1.5%, -2.6 to -0.5). CONCLUSIONS The PAI e-Health Program is feasible, acceptable, and efficacious in people with T2D.
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The effects of a preschool-based intervention for Early Childhood Education and Care teachers in promoting healthy eating and physical activity in young children: A cluster randomised controlled trial.
Toussaint, N, Streppel, MT, Mul, S, Balledux, M, Drongelen, KV, Janssen, M, Fukkink, RG, Weijs, PJM
PloS one. 2021;(7):e0255023
Abstract
The need for excess weight gain prevention in disadvantaged young children is widely recognised. Early Childhood Education and Care teachers are potential key actors in early interventions to prevent overweight and obesity. This study examines the effects of a preschool-based intervention for teachers in promoting healthy eating and physical activity in young children. A cluster randomised controlled trial was conducted at 41 preschools in a deprived area of Amsterdam, The Netherlands. The intervention consisted of 2 programmes that were applied in succession: A Healthy Start and PLAYgrounds for TODdlers. The study period was 9 months. Primary outcomes were assessed via questionnaires and included teachers' knowledge, attitude, food/activity-related practices, and level of confidence in promoting healthy behaviours. Secondary outcomes in this study were teachers' and children's BMI (z-score), body composition, dietary intake and physical activity level. Intention-to-treat analyses were performed using linear mixed models. In total, 115 teachers and 249 children (mean age 3.0 (0.2) years) were included. A positive effect on teachers' knowledge about the Dutch dietary guidelines was found after the programme A Healthy Start (difference = 1.38; 1-sided 95% CL = 0.29; p = 0.02). This effect was not sustained at 9 months (difference = 0.34; 1-sided 95% CL = -0.76; p = 0.31). The overall intervention had a positive effect on 3 of the 5 attitude statements regarding a healthy lifestyle (difference ranged from 0.34 to 0.55) and on the practice scale Activity-related-Modelling (difference = 0.16; 1-sided 95% CL = 0.06; p = 0.01). No intervention effects were observed on food-related practice scales and the level of confidence in promoting healthy behaviours. At this stage, no effects were seen on teachers' and children's BMI (z-score). This study contributes to the professional development of Early Childhood Education and Care teachers and addresses the call for interventions to prevent overweight/obesity and to minimise health inequalities in young children.
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Randomized Controlled Trial for Promotion of Healthy Eating in Older Adults by Increasing Consumption of Plant-Based Foods: Effect on Inflammatory Biomarkers.
Nilsson, A, Cano, A, Bergens, O, Kadi, F
Nutrients. 2021;(11)
Abstract
To what extent the intake of fruit and vegetables (FV) influences inflammatory status remains elusive, particularly in older populations. The aim of the present study was to determine the effect of increased FV intake for 16 weeks on circulating biomarkers of inflammation in a population of older men and women. Sixty-six participants (65-70 years) randomly assigned to either FV or control (CON) groups were instructed to increase FV intake to five servings per day through nutritional counseling (FV) or to maintain habitual diet (CON). Dietary intake and physical activity level (PA) were determined using food frequency questionnaire and accelerometers, respectively, at the start and end of the intervention. C-reactive protein (CRP), interleukin 6 (IL-6), IL-18, macrophage inflammatory protein-1α (MIP-1α), MIP-1β, tumor necrosis factor-α (TNF-α), TNF-related apoptosis-inducing ligand (TRAIL), TNF-related activation-induced cytokine (TRANCE), and C-X3-C motif chemokine ligand-1 (CX3CL1, or fractalkine) were analyzed. The FV group significantly increased daily FV intake (from 2.2 ± 1.3 to 4.2 ± 1.8 servings/day), with no change in CON. Waist circumference and PA level were unchanged by the intervention. Interaction effects (time × group, p < 0.05) for TRAIL, TRANCE, and CX3CL1 denoting a significant decrease (p < 0.05) in FV but not in CON were observed. No corresponding effects on CRP, IL6, TNF-α, MIP-1α, and β and IL-18 were observed. The present study demonstrates the influence of increased FV consumption on levels of some inflammatory biomarkers in a population of older adults. Future work is warranted to examine the clinical implications of FV-induced alterations in these inflammatory biomarkers.
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Evaluation of a community-based mobile video breastfeeding intervention in Khayelitsha, South Africa: The Philani MOVIE cluster-randomized controlled trial.
Adam, M, Johnston, J, Job, N, Dronavalli, M, Le Roux, I, Mbewu, N, Mkunqwana, N, Tomlinson, M, McMahon, SA, LeFevre, AE, et al
PLoS medicine. 2021;(9):e1003744
Abstract
BACKGROUND In South Africa, breastfeeding promotion is a national health priority. Regular perinatal home visits by community health workers (CHWs) have helped promote exclusive breastfeeding (EBF) in underresourced settings. Innovative, digital approaches including mobile video content have also shown promise, especially as access to mobile technology increases among CHWs. We measured the effects of an animated, mobile video series, the Philani MObile Video Intervention for Exclusive breastfeeding (MOVIE), delivered by a cadre of CHWs ("mentor mothers"). METHODS AND FINDINGS We conducted a stratified, cluster-randomized controlled trial from November 2018 to March 2020 in Khayelitsha, South Africa. The trial was conducted in collaboration with the Philani Maternal Child Health and Nutrition Trust, a nongovernmental community health organization. We quantified the effect of the MOVIE intervention on EBF at 1 and 5 months (primary outcomes), and on other infant feeding practices and maternal knowledge (secondary outcomes). We randomized 1,502 pregnant women in 84 clusters 1:1 to 2 study arms. Participants' median age was 26 years, 36.9% had completed secondary school, and 18.3% were employed. Mentor mothers in the video intervention arm provided standard-of-care counseling plus the MOVIE intervention; mentor mothers in the control arm provided standard of care only. Within the causal impact evaluation, we nested a mixed-methods performance evaluation measuring mentor mothers' time use and eliciting their subjective experiences through in-depth interviews. At both points of follow-up, we observed no statistically significant differences between the video intervention and the control arm with regard to EBF rates and other infant feeding practices [EBF in the last 24 hours at 1 month: RR 0.93 (95% CI 0.86 to 1.01, P = 0.091); EBF in the last 24 hours at 5 months: RR 0.90 (95% CI 0.77 to 1.04, P = 0.152)]. We observed a small, but significant improvement in maternal knowledge at the 1-month follow-up, but not at the 5-month follow-up. The interpretation of the results from this causal impact evaluation changes when we consider the results of the nested mixed-methods performance evaluation. The mean time spent per home visit was similar across study arms, but the intervention group spent approximately 40% of their visit time viewing videos. The absence of difference in effects on primary and secondary endpoints implies that, for the same time investment, the video intervention was as effective as face-to-face counseling with a mentor mother. The videos were also highly valued by mentor mothers and participants. Study limitations include a high loss to follow-up at 5 months after premature termination of the trial due to the COVID-19 pandemic and changes in mentor mother service demarcations. CONCLUSIONS This trial measured the effect of a video-based, mobile health (mHealth) intervention, delivered by CHWs during home visits in an underresourced setting. The videos replaced about two-fifths of CHWs' direct engagement time with participants in the intervention arm. The similar outcomes in the 2 study arms thus suggest that the videos were as effective as face-to-face counselling, when CHWs used them to replace a portion of that counselling. Where CHWs are scarce, mHealth video interventions could be a feasible and practical solution, supporting the delivery and scaling of community health promotion services. TRIAL REGISTRATION The study and its outcomes were registered at clinicaltrials.gov (#NCT03688217) on September 27, 2018.
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Improving Toddlers' Healthy Eating Habits and Self-regulation: A Randomized Controlled Trial.
Nix, RL, Francis, LA, Feinberg, ME, Gill, S, Jones, DE, Hostetler, ML, Stifter, CA
Pediatrics. 2021;(1)
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OBJECTIVES In this study, we tested whether Recipe 4 Success, a preventive intervention featuring structured food preparation lessons, was successful in improving the following 4 protective factors related to overweight and obesity among families living in poverty: toddlers' healthy eating habits, toddlers' self-regulation, parents' responsive feeding practices, and parents' sensitive scaffolding. METHODS This randomized controlled trial was open to families enrolled in Early Head Start home visits and included 73 parents and their toddlers aged 18 to 36 months. Multimethod assessments were conducted at baseline and posttreatment. RESULTS Compared with toddlers in usual practice Early Head Start, toddlers in Recipe 4 Success consumed healthier meals and snacks (d = 0.57; P < .03; 95% confidence interval [CI]: 0.08-1.06) and displayed better self-regulation (d = 0.95; P < .001; 95% CI: 0.43-1.45). Compared with parents in usual practice Early Head Start, parents in Recipe 4 Success engaged in more responsive feeding practices (d = 0.87; P < .002; 95% CI: 0.34-1.40) and were better able to sensitively scaffold their toddlers' learning and development (d = 0.58; P < .04; 95% CI: 0.07-1.09). CONCLUSIONS This randomized controlled trial revealed medium to large intervention effects on 4 important protective factors that are related to overweight and obesity but are often compromised by living in poverty.
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Barriers and Facilitators to Lifestyle Intervention Engagement and Weight Loss in People Living With Spinal Cord Injury.
Betts, AC, Ochoa, C, Hamilton, R, Sikka, S, Froehlich-Grobe, K
Topics in spinal cord injury rehabilitation. 2021;(1):135-148
Abstract
Background: Individuals living with spinal cord injury (SCI) have a high prevalence of obesity and unique barriers to healthy lifestyle. Objective: To examine barriers and facilitators to engagement and weight loss among SCI participants enrolled in the Group Lifestyle Balance Adapted for individuals with Impaired Mobility (GLB-AIM), a 12-month intensive lifestyle intervention. Methods: SCI participants (N = 31) enrolled in a wait-list, randomized controlled trial where all participants received intervention between August 2015 and February 2017. Analyses of pooled data occurred in 2020 to examine cross-sectional and prospective associations of hypothesized barriers and facilitators with (1) intervention engagement, comprised of attendance and self-monitoring, and (2) percent weight change from baseline to 12 months. We performed multivariable linear regression on variables associated with outcomes at p < .05 in bivariate analyses and controlled for intervention group. Results: Participants were middle-aged (mean age, 48.26 ± 11.01 years), equally male (50%) and female, White (80.7%), and unemployed (65.6%). In participants who completed baseline surveys (n = 30), dietary self-efficacy explained 26% of variance in engagement (p < .01); among the 12-month study completers (n = 22, 71.0%), relationship issues explained 23% of variance in engagement (p < .01). Money problems, health issues unrelated to SCI, lack of motivation, and experimental group explained 57% of variance in weight loss (p for model < .01), with lack of motivation uniquely explaining 24% of variance (p < .01). Conclusion: Improving engagement and weight loss for persons with SCI in the GLBAIM program may be achieved by addressing lack of motivation, relationship issues, and nutrition self-efficacy.
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A randomized controlled trial comparing community lifestyle interventions to improve adherence to diet and physical activity recommendations: the VitalUM study.
van Keulen, HM, van Breukelen, G, de Vries, H, Brug, J, Mesters, I
European journal of epidemiology. 2021;(3):345-360
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Worldwide, adherence to national guidelines for physical activity (PA), and fruit and vegetable consumption is recommended to promote health and reduce the risk for (chronic) disease. This study reports on the effectiveness of various social-cognitive interventions to improve adherence to guidelines and the revealed adherence predictors. Participants (n = 1,629), aged 45-70 years, randomly selected and recruited in 2005-2006 from 23 Dutch general practices, were randomized (centralized stratified allocation) to four groups to receive a 12-month lifestyle intervention targeting guideline adherence for PA and fruit and vegetable consumption. Study groups received either four computer-tailored print communication (TPC) letters (n = 405), four telephone motivational interviewing (TMI) sessions (n = 407), a combined intervention (two TPC letters and two TMI sessions, n = 408), or no intervention (control group, n = 409). After the baseline assessment, all parties were aware of the treatment groups. Outcomes were measured with self-report postal questionnaires at baseline, 25, 47 and 73 weeks. For PA, all three interventions were associated with better guideline adherence than no intervention. Odds ratios for TPC, TMI and the combined intervention were 1.82 (95% CI 1.31; 2.54), 1.57 (95% CI 1.13; 2.18), and 2.08 (95% CI 1.50; 2.88), respectively. No pedometer effects were found. For fruit and vegetable consumption, TPC seemed superior to those in the other groups. Odd ratio for fruit and vegetable consumption were 1.78 (95% CI 1.32; 2.41) and 1.73 (95% CI 1.28; 2.33), respectively. For each behaviour, adherence was predicted by self-efficacy expectations, habit strength and stages of change, whereas sex, awareness and the number of action plans predicted guideline adherence for fruit and vegetable intake. The season predicted the guideline adherence for PA and fruit consumption. The odds ratios revealed were equivalent to modest effects sizes, although they were larger than those reported in systematic reviews. This study indicated that less resource intensive interventions might have the potential for a large public health impact when widely implemented. The strengths of this study were the participation of lower educated adults and evaluation of maintenance effects. (Trial NL1035, 2007-09-06).
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Effect of a multi-disciplinary active aging intervention among community elders.
Chi, YC, Wu, CL, Liu, HT
Medicine. 2021;(51):e28314
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BACKGROUND Active aging has been the paradigm of the old-age lifestyle. We aimed to investigate the efficacy of a multi-disciplinary intervention program in community-based elderly. METHODS We conducted a 2-arm trial comparing the effectiveness between the study group and the control group. The intervention contents included active aging concepts and preparation, physical activity, health care management, cognitive training, emotional awareness and coping skills, family relationship and resilience, and internet use. A questionnaire tapping into the constructs of the expanded healthy life, mental health, social participation, and active aging was administered at baseline, 7th week, and 19th week. RESULTS The generalized estimating equations analysis revealed that the study group exhibited significant improvements in healthy life, mental health, social participation, and active aging compared with the control group (P < .001). CONCLUSIONS This study provided a good evidence supporting the effectiveness of a multi-disciplinary intervention program in improving the cognition of healthy life, mental health status, social participation activities, and active aging. A promotion of similar intervention is recommended.