A Randomized Controlled Trial Study of Transforming Impossible into Possible (TIP) Policy Experiment in South Korea

2020 ◽  
Vol 30 (6) ◽  
pp. 587-596 ◽  
Author(s):  
Philip Young P. Hong ◽  
Sangmi Choi ◽  
Rana Hong
Keyword(s):  
Randomized Controlled Trial ◽  
South Korea ◽  
Low Income ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Esteem ◽  
Analysis Of Covariance ◽  
Randomized Controlled ◽  
Self Sufficiency

Purpose: This randomized controlled trial (RCT) study examined the efficacy of the Transforming Impossible into Possible (TIP) program for low-income, low-skilled jobseekers in the Self-Sufficiency Program (SSP) in South Korea. Method: A total of 169 participants in SSP regional centers were randomly assigned to the intervention group (104 participants) and the wait-list control group (65 participants). Employment hope, perceived employment barriers, economic self-sufficiency (ESS), self-esteem and self-efficacy were measured at two time points, and data were analyzed using a paired sample t-test and an analysis of covariance (ANCOVA). Results: The TIP intervention group showed statistically significant increase in employment hope, ESS, self-esteem, and self-efficacy. The ANCOVA result indicated significant pre–post score differences in these variables between the TIP and the control groups. Discussion: TIP program can be effective in increasing psychological capital for low-income and low-skilled jobseekers. Further research ought to replicate the current RCT study to determine its application to other populations.

scholarly journals The transtheoretical model is effective for weight management: A randomized controlled trial Intervention for Weight Management

2020 ◽  
Author(s):  
Patrícia Pinheiro de Freitas ◽  
Mariana Carvalho de Menezes ◽  
Luana Caroline dos Santos ◽  
Adriano Marçal Pimenta ◽  
Adaliene Versiani Matos Ferreira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Management ◽  
Nutrition Education ◽  
Stages Of Change ◽  
Low Income ◽  
Transtheoretical Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Randomized Controlled

Abstract Background: Given the current worldwide epidemic of obesity, interventions with higher impact, such as those carried out in the primary health care (PHC) setting, are needed. Considering that, this study aimed to evaluate the effect of intervention performed according to the stages of change of the transtheoretical model (TTM) for weight management. Methods: Randomized controlled trial in Brazilian PHC that offers free physical exercise and nutrition education. The participants were women aged 20 years or older who were obese or overweight in PHC service. The intervention group (IG, n=51) received the same orientation as the comparison group (CG, n==35) plus individual health counselling based on the TTM aiming weight loss, which lasted six months. The outcome measures were anthropometric, food and nutrient profiles. Inflammatory parameters were evaluated in a random subsample. The inter-group and intra-group differences were evaluated and analysis of covariance (ANCOVA) used to assess intervention effectiveness, using intention-to-treat analysis. Results: There was a difference between groups of -1.4 kg (CI95%: -2.5; -0.3) in body weight after the intervention. About 97% of women in the IG reported benefits of intervention and presented positive changes in diet, biochemical markers and anthropometry. The IG showed a better BMI, resistine and blood glucose result when compared to CG during follow-up. Conclusion: The individualized TTM-based intervention combined with usual care was effective strategy in PHC. These results encouragement of interdisciplinary practices; nevertheless, research to identify additional strategies is needed to address barriers to weight maintenance among obesity low-income women.

scholarly journals The transtheoretical model is an effective for weight management intervention: A randomized controlled trial

2020 ◽  
Author(s):  
Patrícia Pinheiro de Freitas ◽  
Mariana Carvalho de Menezes ◽  
Luana Caroline dos Santos ◽  
Adriano Marçal Pimenta ◽  
Adaliene Versiani Matos Ferreira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Management ◽  
Nutrition Education ◽  
Stages Of Change ◽  
Low Income ◽  
Transtheoretical Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Randomized Controlled

Abstract Background: Given the current worldwide epidemic of obesity, there is a demand for interventions with higher impact, such as those carried out in the primary health care (PHC) setting. Here we evaluate the effect of intervention performed according to the stages of change of the transtheoretical model (TTM) for weight management. Methods: This randomized controlled trial in Brazilian PHC offered free physical exercise and nutrition education. The participants were women aged 20 years or older who were obese or overweight in PHC service. The intervention group (IG, n = 51) received the same orientation as the comparison group (CG, n = 35) plus individual health counseling based on the TTM aimed at weight loss, which lasted 6 months. The outcome measures were anthropometric, food, and nutrient profiles. Inflammatory parameters were evaluated in a random subsample. The inter-group and intra-group differences were evaluated, and analysis of covariance (ANCOVA) used to assess intervention effectiveness, using intention-to-treat analysis. Results: There was a difference between groups of -1.4 kg (CI95%: -2.5; -0.3) in body weight after the intervention. About 97% of women in the IG reported benefits of the intervention and presented positive changes in diet, biochemical markers, and anthropometry. The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up. Conclusion: The individualized TTM-based intervention, combined with usual care, was an effective strategy in PHC. These results should encourage the use of interdisciplinary practices; nevertheless, research to identify additional strategies is needed to address barriers to weight maintenance among obese low-income women.Trial registration: The trial is registered with Brazilian clinical trials under the code: RBR-8t7ssv, Registration date: 12/12/2017 (retrospectively registered). URL: http://www.ensaiosclinicos.gov.br/rg/RBR-8t7ssv/

scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Lactating Women ◽  
Randomized Controlled ◽  
Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

scholarly journals Effects of an attachment-based parent intervention on mothers of children with autism spectrum disorder: preliminary findings from a non-randomized controlled trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Nobuyo Kubo ◽  
Megumi Kitagawa ◽  
Sayaka Iwamoto ◽  
Toshifumi Kishimoto
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Control Group ◽  
Randomized Controlled ◽  
Children With Asd

Abstract Background Caregivers of children with autism spectrum disorders (ASD) often experience difficulties in responding appropriately to the needs of those children, who typically express attachment in distinct and nonconventional ways. This highlights the need for an attachment-based approach targeted at caregivers of children with ASD. Circle of Security Parenting (COSP), an attachment-based parenting program, is designed to increase caregivers’ sensitivity to children’s attachment needs. The aim of this study was to provide verification of the effectiveness of COSP in mothers of children with ASD. Methods This study was a non-randomized controlled trial. Sixty mothers of children with ASD aged 4–12 were recruited. Twenty mothers received the COSP intervention, while 40 did not. The characteristics of children in the control group were matched with those of the intervention group. To evaluate the outcomes of the intervention, changes in parental self-efficacy and mental health were assessed using the Tool to Measure Parenting Self-Efficacy (TOPSE) and the General Health Questionnaire-30 (GHQ-30). The children’s improvement in emotional and behavioral problems was assessed from the mothers’ perspective using the Child Behavior Checklist (CBCL). Both groups completed the assessments in parallel. Evaluations were compared between baseline (T1) and 6-month follow-up (T2). Results Scores for self-efficacy and mental health of mothers and behavior of children were significantly improved from T1 to T2 in the intervention group, but not in the control group. Participants’ mental health was markedly worsened in the control group. Conclusion This study demonstrated that the COSP program for mothers of children with ASD improved their parental self-efficacy and mental health, and reduced their subjective sense of difficulties related to their children’s behaviors. Our findings support the effectiveness of the attachment-based program for mothers of children with ASD, providing the groundwork for further studies of the attachment-based intervention for children with ASD and their families. Future studies with larger samples and randomization are also needed for direct evaluation of the improvement of children's attachment security, and for exploration of the synergistic relationship between various family support strategies and COSP. Trial Registration This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (No. UMIN000039574)

scholarly journals Nurse-led continuum of care for people with diabetes and pre-diabetes in Nepal (NUCOD): study protocol for a cluster randomized controlled trial

2020 ◽  
Author(s):  
Dong (Roman) Xu ◽  
Rubee Dev ◽  
Abha Shrestha ◽  
Lingling Zhang ◽  
Archana Shrestha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Continuum Of Care ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Implementation Outcomes ◽  
Cluster Randomized

Abstract Background: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal. Methods: We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NU rse-led CO ntinuum of care for people with D iabetes (N1=200) and pre-diabetes (N2=1036) (NUCOD) , with primary care centers (9 Outreach Centers and 17 Government Health Posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among prediabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis. Discussion: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. Trial registration: This study was registered in a clinical trials registry via ClinicalTrials.gov (NCT04131257) on 18 October 2019. https://bit.ly/34qwIAd

scholarly journals Effect of Continues Midwifery Support in Labor on the Childbirth Experience and Self-Esteem of Primipara Women: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nasrin Soleimani ◽  
Mansoureh Refaei ◽  
Farideh Kazemi
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Esteem ◽  
Control Group ◽  
Randomized Controlled ◽  
Childbirth Experience ◽  
Cohen’S D ◽  
The Mean ◽  
Cohen's D

Abstract Background: The World Health Organization states that mothers during labor and delivery should be supported by people with whom they feel comfortable, because one of the non-pharmacological methods of relieving labor pain is the continued support of midwives in labor. The primary objectives of this study were to determine the effect of continuous midwifery support in labor on delivery experience and self-esteem of nulliparous women 6 weeks after delivery.Methods: This randomized controlled trial was performed in 2021 on 70 pregnant women admitted to the delivery ward who met the inclusion criteria. Participants were randomly allocated to two groups through balanced block randomization with a block size of 4. Participants completed a demographic and midwifery information questionnaire before entering the study. In the intervention group, in addition to routine labor care, the researcher was present at the mother's bedside and was present with the mother continuously throughout the labor and up to 2 hours after delivery and provided the necessary support. The control group received only routine labor and postpartum care. Six weeks after delivery, participants in both groups were contacted to complete the CEQ and Rosenberg self-esteem questionnaires. Finally, data were collected and analyzed. Significance level was considered 0.05.Results: By controlling the effect of duration of the first and second stages of labor as potential confounders, the mean (sd) of childbirth experience 6 weeks after delivery was 70.92 (7.07) in the intervention group and 59.69 (7.08) in the control group, and this difference was statistically significant (p <0.001). The amount of effect size indicates a very strong effect of the intervention on improving the childbirth experience (Cohen’s d = 1.69; 95% CI: 1.12, 2.26). Comparison of the mean of maternal self-esteem showed that this rate in the intervention group was 2 scores higher than the control group and this difference was statistically significant (p = 0.05). Cohen's d indicates the average effect of intervention on mothers' self-esteem score (Cohen's d = 0.56; 95% CI: 0.06, 1.05).Conclusions: Continuous support of the midwife in labor and up to 2 hours after delivery can lead to a better childbirth experience and increase the mother's self-esteem up to 6 weeks after delivery.Trial registration: IRCT ID: IRCT20201102049233N1, First Registration date: 2021-06-04

scholarly journals Traffic-light labels and financial incentives to reduce sugar-sweetened beverage purchases by low-income Latino families: a randomized controlled trial

2018 ◽  
Vol 21 (8) ◽  
pp. 1426-1434 ◽  
Author(s):  
Rebecca L Franckle ◽  
Douglas E Levy ◽  
Lorena Macias-Navarro ◽  
Eric B Rimm ◽  
Anne N Thorndike
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Traffic Light ◽  
Sugar Sweetened Beverages ◽  
Randomized Controlled ◽  
Sweetened Beverages

AbstractObjectiveThe objective of the present study was to test the effectiveness of financial incentives and traffic-light labels to reduce purchases of sugar-sweetened beverages in a community supermarket.DesignIn this randomized controlled trial, after a 2-month baseline period (February–March 2014), in-store traffic-light labels were posted to indicate healthy (green), less healthy (yellow) or unhealthy (red) beverages. During the subsequent five months (April–August 2014), participants in the intervention arm were eligible to earn a $US 25 in-store gift card each month they refrained from purchasing red-labelled beverages.SettingUrban supermarket in Chelsea, MA, USA, a low-income Latino community.SubjectsParticipants were customers of this supermarket who had at least one child living at home. A total of 148 customers (n 77 in the intervention group and n 71 in the control group) were included in the final analyses.ResultsOutcomes were monthly in-store purchases tracked using a store loyalty card and self-reported consumption of red-labelled beverages. Compared with control participants, the proportion of intervention participants who purchased any red-labelled beverages decreased by 9 % more per month (P=0·002). More intervention than control participants reduced their consumption of red-labelled beverages (−23 % v. −2 % for consuming ≥1 red beverage/week, P=0·01).ConclusionsOverall, financial incentives paired with in-store traffic-light labels modestly reduced purchase and consumption of sugar-sweetened beverages by customers of a community supermarket.

scholarly journals A randomized controlled trial of the effects of antenatal milk expression on breastfeeding among first-time mothers in China

2020 ◽  
Author(s):  
yan chen ◽  
Li-Ping Meng ◽  
Jiao-Jiao Zhang ◽  
Hong-Hua Guo ◽  
hongyu zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Exclusive Breastfeeding ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
First Time Mothers ◽  
First Time

Abstract Background Limited research outside China suggest that antenatal milk expression in late pregnancy (AME) may promote breastfeeding. A few studies have evaluated the safety and efficacy of AME in women with diabetes in pregnancy, little or no evidence exists to explore its effects on breastfeeding self-efficacy and early breastfeeding, particularly in first-time mothers. The objective of this study was to explore the effect of AME on breastfeeding for the first-time mothers during the postpartum hospitalization. Methods A randomized controlled trial was conducted in a tertiary hospital in Haikou, Hainan. We recruited pregnant women who had completed 37 weeks of gestation and randomly assigned them to either the intervention group (n = 45) or the control group (n = 45). The pregnant women in the intervention group were advised to rhythmic self-massage of breasts three times daily at any time. The control group was given routine midwifery and obstetric care. The breastfeeding self-efficacy scale(BSES)was used to measure the self-efficacy of breastfeeding at 37 weeks, 38 weeks and the third day postpartum. The time to lactogenesis II and the rate of exclusive breastfeeding was measured three times every day by the researcher in the ward. Results Compared with the control group, the intervention group had higher breastfeeding self-efficacy scores measured by the scale of BSES(P < 0.05), the intervention group had higher exclusive breastfeeding rate on the first day, second day, third-day postpartum, and the difference was statistically significant༈P < 0.05). The time to lactogenesis II in the intervention group was earlier than that in the control group(P < 0.05). Conclusions Antenatal breast milk expression at term improved the confidence in the ability to breastfeed and produce milk postpartum, thus significantly improving the behavior of exclusive breastfeeding, and increasing the percentage of breastfed infants during their hospital stay, these infants were able to avoid infant formula milk in this important early period.

scholarly journals Nurse-led continuum of care for people with diabetes and pre-diabetes in Nepal (NUCOD): study protocol for a cluster randomized controlled trial

2020 ◽  
Author(s):  
Dong (Roman) Xu ◽  
Rubee Dev ◽  
Abha Shrestha ◽  
Lingling Zhang ◽  
Archana Shrestha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Continuum Of Care ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Implementation Outcomes ◽  
Cluster Randomized

Abstract Background: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.Methods: We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of a NUrse-led COntinuum of care for people with Diabetes (N1=200) and pre-diabetes (N2=1036) (NUCOD), with primary care centers (9 Outreach Centers and 17 Government Health Posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among prediabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis.Discussion: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other non-communicable diseases within and beyond Nepal with similar context.Trial registration: This study was registered in a clinical trials registry via ClinicalTrials.gov (NCT04131257) on 18 October 2019. URL: https://bit.ly/34qwIAd

scholarly journals Efficacy of a Web-Based Self-Management Enhancing Program for Patients with Rheumatoid Arthritis: Explorative Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Rixt Zuidema ◽  
Sandra van Dulmen ◽  
Maria Nijhuis-van der Sanden ◽  
Inger Meek ◽  
Cornelia van den Ende ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Web Based ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Web-based self-management enhancing programs have the potential to support patients with rheumatoid arthritis (RA) in their self-management; for example, improve their health status by increasing their self-efficacy or taking their prescribed medication. We developed a Web-based self-management enhancing program in collaboration with RA patients and professionals as co-designers on the basis of the intervention mapping framework. Although self-management programs are complex interventions, it is informative to perform an explorative randomized controlled trial (RCT) before embarking on a larger trial. OBJECTIVE This study aimed to evaluate the efficacy of a Web-based self-management enhancing program for patients with RA and identify outcome measures most likely to capture potential benefits. METHODS A multicenter exploratory RCT was performed with an intervention group and a control group. Both groups received care as usual. In addition, the intervention group received 12 months of access to a Web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included self-management behavior (Patient Activation Measurement, Self-Management Ability Scale), self-efficacy (Rheumatoid Arthritis task-specific Self-Efficacy, Perceived Efficacy in Patient-Physician Interaction), general health status (RAND-36), focus on fatigue (Modified Pain Coping Inventory for Fatigue), and perceived pain and fatigue (Numeric Rating Scales). A linear mixed model for repeated measures, using the intention-to-treat principle, was applied to study differences between the patients in the intervention (n=78) and control (n=79) groups. A sensitivity analysis was performed in the intervention group to study the influence of patients with high (N=30) and low (N=40) use of the intervention. RESULTS No positive effects were found regarding the outcome measurements. Effect sizes were low. CONCLUSIONS Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcome measures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performed to provide more insight into the low compliance with and effectiveness of the intervention. This can determine for whom this sort of program will work and help to fine-tune the inclusion criteria. CLINICALTRIAL Netherlands Trial Register NTR4871; https://www.trialregister.nl/trial/4726

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