Dissemination of an Efficacious Antenatal Smoking Cessation Program in Public Hospitals in Australia: A Randomized Controlled Trial

This study investigated the impact of a behaviorally based intervention designed to increase the number of hospitals that routinely provide effective smoking cessation programs for pregnant women. In Queensland, Australia, 70 publicly funded hospitals were matched on numbers of births and maternal socioeconomic status and randomly allocated to an awareness-only intervention group or a behaviorally based intervention group. Success was defined as the routine offer of an evidence-based smoking cessation program to at least 80% of the pregnant clients who smoke. At 1 month, 65% of the behaviorally based intervention hospitals agreed to provide materials about smoking cessation programs for their antenatal patients, compared with 3% of the awarenessonly hospitals. After 1 year, 43% of the intervention hospitals still provided the material, compared with 9% of the awareness-only hospitals. These findings showthat a brief intervention to hospitals can encourage antenatal staff to provide smoking cessation materials to pregnant women.

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Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

10.21203/rs.3.rs-634069/v1 ◽

2021 ◽

Author(s):

Mira Trisyani Koeryaman ◽

Saseendran Pallikadavath ◽

Isobel Ryder ◽

Ngianga Kandala

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Food Record ◽

Randomized Controlled ◽

The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

10.20944/preprints202103.0097.v1 ◽

2021 ◽

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Effect of hydration with oral water on nonstress test in a hospital, Turkey: a randomized controlled trial

Journal of Health Research ◽

10.1108/jhr-12-2020-0647 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Yeter Şener ◽

Hüseyin Aksoy ◽

Mürüvvet Başer

Keyword(s):

Pregnant Women ◽

Controlled Trial ◽

Stress Test ◽

Intervention Group ◽

Median Number ◽

Control Group ◽

Normal Range ◽

Content Type ◽

Randomized Controlled ◽

Study Intervention

PurposeThe aim of this study was to assess the effect of hydration with oral water on non-stress test (NST).Design/methodology/approachThe study was conducted as single-blinded and randomized controlled. Healthy and outpatient 32- to 40-week pregnant women who were aged 19 and older were included in the study. Intervention group pregnant women (n = 66) drank 500 ccs of water before the NST, and no attempt was made to the control group (n = 66). The NST parameters of the groups with fetal heart rate (FHR), variability, acceleration, deceleration, reactivity and nonreactivity were evaluated.FindingsBoth groups were found to be similar in terms of their descriptive characteristics and variables related to pregnancy (p > 0.05). The median FHR was 130.0 in the intervention group, 140.0 in the control group (p < 0.001), and the median number of the acceleration was 6.0 in the intervention group and 4.0 in the control group (p < 0.001). In terms of the median number of decelerations, the groups were similar (p > 0.05).Originality/valueIt was found that hydration with oral water had an effect on NST parameters of FHR and the number of accelerations. However, it was observed that the FHR was within the normal range in both groups. It was thought that it tended to increase the number of accelerations.

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The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.98256 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Maryam Montazeri ◽

Khalil Esmaeilpour ◽

Sakineh Mohammad-Alizadeh-Charandabi ◽

Sevda Golizadeh ◽

Mojgan Mirghafourvand

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Block Design ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Writing Therapy ◽

Randomized Block Design ◽

Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

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A Nutrition Education Intervention Using NOVA Is More Effective Than MyPlate Alone: A Proof-of-Concept Randomized Controlled Trial

Nutrients ◽

10.3390/nu11122965 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2965

Author(s):

Aydin Nazmi ◽

Marilyn Tseng ◽

Derrick Robinson ◽

Dawn Neill ◽

John Walker

Keyword(s):

Nutrition Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Education Intervention ◽

Proof Of Concept ◽

Food Groups ◽

Randomized Controlled ◽

The Impact ◽

Level Of Processing

The ability to classify foods based on level of processing, not only conventional MyPlate food groups, might be a useful tool for consumers faced with a wide array of highly processed food products of varying nutritional value. The objective of this study was to assess the impact of a proof-of-concept nutrition education intervention on nutrition knowledge, assessed by correct classification of foods according to MyPlate food groups, MyPlate ‘limit’ status (for fat, sugar, sodium), and level of processing (NOVA categories). We utilized a randomized, controlled design to examine the impact of a MyPlate vs. combined MyPlate + NOVA intervention vs. control group. Intervention groups received educational flyers via email and participants were assessed using electronic baseline and follow-up surveys. The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and ‘limit’ status. Moreover, the MyPlate + NOVA group far outperformed the other groups on classifying NOVA categories. Longer-term trials are needed, but our results suggest that NOVA principles may be more easily understood and applied than those of MyPlate. Education strategies focusing on level of food processing may be effective in the context of the modern food environment.

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Effects of guided counseling during pregnancy on birth weight of newborns in West Gojjam Zone, Ethiopia: a cluster-randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-020-02363-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Yeshalem Mulugeta Demilew ◽

Getu Degu Alene ◽

Tefera Belachew

Keyword(s):

Birth Weight ◽

Pregnant Women ◽

Nutrition Education ◽

Controlled Trial ◽

Intervention Group ◽

Average Birth Weight ◽

Randomized Controlled ◽

West Gojjam ◽

Cluster Randomized ◽

West Gojjam Zone

Abstract Background The high proportion of birth weight in Ethiopia is hypothesized to be due to inadequate maternal diet which is associated with poor nutrition education during pregnancy. There was no study that evaluated the effect of nutrition education on birth weight in the study area. This study aimed to assess the effects (overall, direct and indirect effects) of guided counseling on the birth weight of neonates. Methods A two-arm parallel cluster randomized controlled community trial was conducted from May 1, 2018, to April 30, 2019, in West Gojjam Zone, Northwest Ethiopia. At the baseline, 346 pregnant women in the 11 intervention clusters and 348 pregnant women in the 11 control clusters were recruited. However, birth weight was measured from 258 and 272 newborns in the intervention and control groups, respectively. In the intervention group, counseling was given monthly for four consecutive months in the participant’s homes. Besides, leaflets with key counseling messages were distributed to each woman in the intervention arm. Pregnant women who attended routine nutrition education given by the health system were recruited as control. Dietary practice, nutritional status, and birth weight were the primary, secondary and tertiary outcomes of this intervention. Data were collected using a structured data collection tool. Birth weight was measured within 48 h after birth. Independent sample t-test, linear mixed-effects model, and path analysis were fitted to assess effects of the intervention. Results The intra-cluster correlation coefficient was 0.095. The average birth weight of newborns in the intervention group was 0.257 kg higher compared with their counterparts in the control arm (β = 0.257, P < 0.001). The direct effect of this intervention on birth weight was 0.17 (β = 0.17, P<0.001 ) whereas the indirect effect of this intervention was 0.08 (β = 0.08, P<0.001 ). Conclusion Counseling using the health belief model and the theory of planned behavior has a positive effect on improving birth weight. The findings suggest the need for enhancing nutrition education of pregnant women through the application of theories to improve birth weight. Trial registration Clinical Trials.gov NCT03627156, “Retrospectively registered Jun, 13, 2018”.

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