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

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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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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The Effect of Providing Eggs Early in Complementary Feeding on Energy Intake and Dietary Diversity: The Mazira Project Randomized Controlled Trial

Current Developments in Nutrition ◽

10.1093/cdn/nzaa053_068 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 863-863

Author(s):

Chessa Lutter ◽

Bess Caswell ◽

Charles Arnold ◽

Lora Iannotti ◽

Elizabeth Prado ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Young Children ◽

Energy Intake ◽

Complementary Feeding ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Minimum Dietary Diversity

Abstract Objectives Complementary feeding diets in low- and middle-income countries are usually inadequate to meet requirements for healthy growth and development. Food-based interventions may prevent nutrient inadequacies provided they do not replace other nutrient-rich foods. They may also be more sustainable than manufactured food supplements. We describe the contribution of daily egg supplementation to usual energy intake, usual energy intake by food group, and minimum dietary diversity of rural Malawian infants and young children. Methods We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were randomly allocated to receive an egg a day for 6 months or to a control group. Dietary intake of foods and drinks was assessed at baseline, 3-month midline, and 6-month endline visits using a tablet-based mulitpass 24-hour recall. Up to two repeat recalls were collected at each timepoint in a subsample of 100 children per intervention group. Results The intervention resulted in an increased usual energy intake in the intervention group of 30 kcal at midline (P = 0.128) and 36 kcal at endline (P = 0.087). It also resulted in a 7 kcal displacement of legumes and nuts in children at endline (P = 0.059). At midline and endline, usual energy intake from eggs was about 30 kcal higher in the egg group compared to controls (P < 0.0001). Compared to controls, children in the egg group were over 9 times more likely to consume eggs at midline and endline. At midline and endline more than 80% of children in the egg group consumed a minimally diverse diet compared to 53% at midline and 60% at endline in the control group. Conclusions Mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other nutrient-rich complementary foods. The intervention resulted in higher energy intake from eggs, greater dietary diversity, and an increased percentage of children meeting a minimum dietary diversity cutoff. Funding Sources Bill & Melinda Gates Foundation.

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The Impact of Implementing Steps of Empowerment Model on Decisional Conflict for Re-Pregnancy for Women with Failed Pregnancies: A Randomized Controlled Trial

10.53350/pjmhs211551604 ◽

2021 ◽

Vol 15 (5) ◽

pp. 1604-1615

Author(s):

Mozhgan Zareyee Salehabadi ◽

Masoomeh Kheirkhah ◽

Nazanin Esmaeeli ◽

Shima Haghani

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Control Group ◽

Random Allocation ◽

Decision Conflict ◽

Randomized Controlled ◽

Empowerment Model ◽

The Impact

Background: Failed pregnancy is known as a common and destructive experience. It has physical and psychological effects on both women and their families. Due to this experience, they may become reluctant to be pregnant again. In this regard, providing the coping strategies can help in being adapted to failed pregnancies, and making informed decisions on future pregnancies. So, this study was designed and then performed to determine the effect of implementing steps of empowerment model on decision conflict for re-pregnancy for women with failed pregnancies Method: This interventional research was a randomized controlled trial with a control group conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during the past 3-6 weeks due to failed pregnancies. Afterward, the eligible women were divided into the two groups of intervention (n=40) and control (n=40) with random allocation of sealed envelope site and a separate code was then determined for each person. The intervention was performed in four sessions lasted for 90-minute based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed in both groups once before and once six weeks after intervention. The obtained data were analyzed using SPSS edition 16 with the independent T-test, Fisher, and chi-squared tests. Results The scores of decisional conflict and its subscales had no differences between the two groups before the intervention (P = 0.65). However, by passing six weeks from the intervention, the decisional conflict and all its subscales have reduced in the intervention group. (P < 0.001). Conclusion: Empowerment education in women with failed pregnancies improved their decision conflict in immune re-pregnancy, so empowerment education along with health care services is recommended for women with failed pregnancies. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019. https://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5336 Keywords: Empowerment, Conflict, Decision Making, Failed Pregnancy.

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Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/23273 ◽

2020 ◽

Vol 22 (12) ◽

pp. e23273

Author(s):

Qiong Wu ◽

Yiwen Huang ◽

Zijun Liao ◽

Michelle Helena van Velthoven ◽

Wei Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Exclusive Breastfeeding ◽

Controlled Trial ◽

Intervention Group ◽

Mobile Technologies ◽

Control Group ◽

Randomized Controlled ◽

Breastfeeding Rate ◽

Significant Difference

Background The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors. Objective This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices. Methods This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum. Results At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%). Conclusions This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs. Trial Registration Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7676-2

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The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: a randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03674-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sepideh Dinmohammadi ◽

Mohsen Dadashi ◽

Elahe Ahmadnia ◽

Leila Janani ◽

Roghieh Kharaghani

Keyword(s):

Quality Of Life ◽

Domestic Violence ◽

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Solution Focused

Abstract Background Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence. Methods A randomized controlled trial on 90 pregnant women was blocked into two intervention groups (n = 45) and a control (n = 45). The intervention group received six counseling sessions with a solution-focused approach. Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The tools were completed once before the intervention and again 6 weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant. Results A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps = 0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P = 0.001). Conclusion Solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence. Trial registration Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

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The Impact of Implementing Steps of Empowerment Model for Women with Failed Pregnancies on Decisional Conflict for Re-pregnancy: A Randomized Controlled Trial

10.21203/rs.3.rs-34460/v1 ◽

2020 ◽

Author(s):

Masoomeh Kheirkhah ◽

Mozhgan Zareyee Salehabadi ◽

Nazanin Esmaeeli ◽

Shima Haghani

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Control Group ◽

Random Allocation ◽

Decision Conflict ◽

Randomized Controlled ◽

Empowerment Model ◽

The Impact

Abstract Background: Failed pregnancy is a common and destructive experience. It has physical and psychological effects on both women and families. They may become reluctant to re-pregnancy. Providing the coping strategies can help to adapt to failed pregnancies, and make informed decisions about future pregnancies. This study was designed and performed to determine the effect of implementing steps of empowerment model for women with failed pregnancies on decision conflict for re-pregnancy. Method: This interventional research is a randomized controlled trial with a control group that was conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during past 3-6 weeks due to failed pregnancies. The eligible women with random allocation of sealed envelope site were divided into two groups of intervention (n=40) and control (n=40) and a separate code was determined for each person. The intervention was performed in four, 90-minute sessions based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed before and six weeks after intervention by both of groups. Data were analyzed using SPSS edition 16 with the independent T-test, Fisher and chi-squared tests. Results: The score of decisional conflict and, its subscales did not differ between the two groups before the intervention (P = 0.65), but six weeks after the intervention, the decisional conflict and, all its subscales in the intervention group reduced. (P < 0.001).Conclusion: Empowerment education in women with a failed pregnancy improved their decision conflict in re-pregnancy, so empowerment education along with health care services for women with failed pregnancies is recommended. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019.

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A Randomized Controlled Trial of the Impact of a Teaching Procedure Service on the Training of Internal Medicine Residents

Journal of Graduate Medical Education ◽

10.4300/jgme-d-11-00136.1 ◽

2012 ◽

Vol 4 (2) ◽

pp. 170-175 ◽

Cited By ~ 10

Author(s):

Michelle Mourad ◽

Sumant Ranji ◽

Diane Sliwka

Keyword(s):

Internal Medicine ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

First Year ◽

Randomized Controlled ◽

Teaching Procedure ◽

Viable Solution ◽

The Impact

Abstract Introduction Academic medical centers must provide safe inpatient procedures while balancing resident autonomy and education. We performed a randomized, controlled trial to evaluate the effect of a 2-week hospitalist procedure service (HPS) rotation on interns' self-perceived procedure ability, knowledge, and autonomy versus the standard curriculum. Methods We randomly selected 16 of 57 internal medicine interns (28%) to participate in the intervention group rotation, with 29 interns in the control group. All interns were surveyed before the start of residency and at the end of the postgraduate year-1 (PGY-1) and PGY-2 years to evaluate self-reported knowledge and ability to (1) safely perform procedures, (2) supervise procedures, and (3) use bedside ultrasound. Results Ninety-four percent of HPS interns (15/16) and 71% of control interns (29/41) completed all surveys. Baseline knowledge and experience did not differ significantly between the groups. The intervention group performed significantly more paracentesis (9 versus 4; P < .001), thoracentesis (6 versus 2; P < .001), and lumbar puncture (4 versus 3; P < .001) procedures than did the control group. After their first year, residents who completed the HPS rotation rated their ability to safely perform and supervise all of the assessed procedures as higher (P < .05 for all procedures) and were more likely to rate self-perceived knowledge as very good or excellent in all surveyed aspects of procedure performance (P < .05). Discussion A 2-week hospitalist-supervised procedure service rotation substantially improved residents' experience, confidence, and knowledge in performing bedside procedures early in their training, with this effect sustained through the PGY-2 year. Standardized procedure service rotations are a viable solution for programs seeking to improve their procedure-based education.

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