Randomised controlled trial with economic and process evaluations of domiciliary welfare rights advice for socioeconomically disadvantaged older people recruited via primary health care (the Do-Well study)

BackgroundWelfare rights advice services are effective at maximising previously unclaimed welfare benefits, but their impact on health has not been evaluated.ObjectiveTo establish the acceptability, cost-effectiveness and effect on health of a domiciliary welfare rights advice service targeting older people, compared with usual practice.DesignA pragmatic, individually randomised, parallel-group, single-blinded, wait-list controlled trial, with economic and process evaluations. Data were collected by interview at baseline and 24 months, and by self-completion questionnaire at 12 months. Qualitative interviews were undertaken with purposive samples of 50 trial participants and 17 professionals to explore the intervention’s acceptability and its perceived impacts.SettingParticipants’ homes in North East England, UK.ParticipantsA total of 755 volunteers aged ≥ 60 years, living in their own homes, fluent in English and not terminally ill, recruited from the registers of 17 general practices with an Index of Multiple Deprivation within the most deprived two-fifths of the distribution for England, and with no previous access to welfare rights advice services.InterventionsWelfare rights advice, comprising face-to-face consultations, active assistance with benefit claims and follow-up as required until no longer needed, delivered in participants’ own homes by a qualified welfare rights advisor. Control group participants received usual care until the 24-month follow-up, after which they received the intervention.Main outcome measuresThe primary outcome was health-related quality of life (HRQoL), assessed using the CASP-19 (Control, Autonomy, Self-realisation and Pleasure) score. The secondary outcomes included general health status, health behaviours, independence and hours per week of care, mortality and changes in financial status.ResultsA total of 755 out of 3912 (19%) general practice patients agreed to participate and were randomised (intervention,n = 381; control,n = 374). In the intervention group, 335 participants (88%) received the intervention. A total of 605 (80%) participants completed the 12-month follow-up and 562 (75%) completed the 24-month follow-up. Only 84 (22%) intervention group participants were awarded additional benefits. There was no significant difference in CASP-19 score between the intervention and control groups at 24 months [adjusted mean difference 0.3, 95% confidence interval (CI) –0.8 to 1.5], but a significant increase in hours of home care per week in the intervention group (adjusted difference 26.3 hours/week, 95% CI 0.8 to 56.1 hours/week). Exploratory analyses found a weak positive correlation between CASP-19 score and the amount of time since receipt of the benefit (0.39, 95% CI 0.16 to 0.58). The qualitative data suggest that the intervention was acceptable and that receipt of additional benefits was perceived by participants and professionals as having had a positive impact on health and quality of life. The mean cost was £44 per participant, the incremental mean health gain was 0.009 quality-adjusted life-years (QALYs) (95% CI –0.038 to 0.055 QALYs) and the incremental cost-effectiveness ratio was £1914 per QALY gained.ConclusionsThe trial did not provide sufficient evidence to support domiciliary welfare rights advice as a means of promoting health among older people, but it yielded qualitative findings that suggest important impacts on HRQoL. The intervention needs to be better targeted to those most likely to benefit.Future workFurther follow-up of the trial could identify whether or not outcomes diverge among intervention and control groups over time. Research is needed to better understand how to target welfare rights advice to those most in need.Trial registrationCurrent Controlled Trials ISRCTN37380518.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 7, No. 3. See the NIHR Journals Library website for further project information. The authors also received a grant of £28,000 from the North East Strategic Health Authority in 2012 to cover the costs of intervention delivery and training as well as other non-research costs of the study.

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One-to-one volunteer befriending to reduce symptoms of depression in people with intellectual disability: a feasibility RCT

Public Health Research ◽

10.3310/phr09100 ◽

2021 ◽

Vol 9 (10) ◽

pp. 1-80

Author(s):

Afia Ali ◽

Emma Mckenzie ◽

Zara Rasoul ◽

Angela Hassiotis ◽

Stefan Priebe ◽

...

Keyword(s):

Quality Of Life ◽

Intellectual Disability ◽

Depressive Symptoms ◽

Health Research ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Public Health Research ◽

Randomised Controlled

Background Little is known about the effectiveness of befriending for people with intellectual disability and whether or not befriending improves depressive symptoms and social outcomes. Objective This pilot trial aimed to assess the feasibility and acceptability of conducting a future full-scale randomised controlled trial of one-to-one befriending for people with intellectual disability who had depressive symptoms. Design This was a parallel-group, two-armed randomised controlled trial incorporating an exploratory economic analysis and a mixed-methods process evaluation. Outcome assessments were conducted at baseline and at 6 months post randomisation by a research assistant who was blind to allocation. We aimed to approach 50 participants, with a view to recruiting 40. Setting Participants with intellectual disability were recruited from one NHS trust and from referrals to two community befriending services. The intervention was delivered by community befriending services. Participants Adults with mild or moderate intellectual disability with a score on the Glasgow Depression Scale for people with a Learning Disability of ≥ 5 were included. Those attending a day service/college for ≥ 3 days a week were excluded. Volunteers were aged ≥ 18 years and had no history of prior convictions. Intervention Participants in the intervention group were matched with a volunteer befriender and were expected to meet once per week for 1 hour, over 6 months. Volunteers recorded activities in a logbook. Volunteers received training and regular supervision. Both groups received usual care and a resource booklet of local activities. Main outcome measures The feasibility outcomes and progression criteria were recruitment of at least 70% of participants approached; matching of at least 70% of participants in the intervention group to a volunteer; a dropout rate of < 30% of participants and volunteers; adherence to the intervention (10 meetings between pairs); acceptability of the intervention; and feasibility of collecting data on costs and resource use for an economic evaluation. Changes in depressive symptoms (primary clinical outcome: Glasgow Depression Scale) and self-esteem, quality of life, social participation, social support, health-related quality of life and service use were recorded at 6 months. Outcomes in volunteers were also assessed. Results We recruited only 16 participants with intellectual disability (40% of target) and 10 volunteers. Six of the eight (75%) participants in the intervention group were matched with a befriender and there was good adherence (mean number of meetings attended 11.8; range 1–21 meetings). Going to a cafe/restaurant and having a conversation were the most frequent activities. All participants were retained at follow-up, but two volunteers dropped out. Trial procedures and the intervention might be acceptable, but modifications were suggested. Data on costs and resource use were obtained, but there were discrepancies in the health-related quality-of-life data. Limitations Delays to the study prevented the use of alternative recruitment strategies and the planned 12-month follow-up could not be completed. Conclusions Recruitment was not feasible, but other feasibility outcomes were more positive. Future work Evaluating befriending for people with intellectual disability could be explored through alternative study designs, such as observational studies. Trial registration Current Controlled Trials ISRCTN63779614. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 10. See the NIHR Journals Library website for further project information.

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All-Wales Licensed Premises Intervention (AWLPI): a randomised controlled trial of an intervention to reduce alcohol-related violence

Public Health Research ◽

10.3310/phr03100 ◽

2015 ◽

Vol 3 (10) ◽

pp. 1-152 ◽

Cited By ~ 1

Author(s):

Simon C Moore ◽

Mohammed Fasihul Alam ◽

David Cohen ◽

Kerenza Hood ◽

Chao Huang ◽

...

Keyword(s):

Public Health ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Health Research ◽

Controlled Trial ◽

Public Health Research ◽

Licensed Premises ◽

Randomised Controlled ◽

And Control

BackgroundViolence in and around premises licensed for the on-site sale and consumption of alcohol continues to burden the NHS with assault-related injuries.Trial designA randomised controlled trial with licensed premises as the unit of allocation, with additional process and cost-effectiveness evaluations.MethodsPremises were eligible (n = 837) if they were licensed for on-site sale and consumption of alcohol, were within 1 of the 22 local authorities (LAs) in Wales and had previously experienced violence. Data were analysed using Andersen–Gill recurrent event models in an intention-to-treat analysis. An embedded process evaluation examined intervention implementation, reach, fidelity, dose and receipt. An economic evaluation compared costs of the intervention with benefits.InterventionPremises were randomised to receive a violence-reduction intervention, Safety Management in Licensed Environments (SMILE), which was delivered by an environmental health practitioner (EHP; the agent). SMILE consisted of an initial risk audit to identify known risks of violence, a follow-up audit scheduled to enforce change for premises in which serious risks had been identified, structured advice from EHPs on how risks could be addressed in premises and online materials that provided educational videos and related material.ObjectiveTo develop intervention materials that are acceptable and consistent with EHPs’ statutory remit; to determine the effectiveness of the SMILE intervention in reducing violence; to determine reach, fidelity, dose and receipt of the intervention; and to consider intervention cost-effectiveness.OutcomeDifference in police-recorded violence between intervention and control premises over a 455-day follow-up period.RandomisationA minimum sample size of 274 licensed premises per arm was required, rounded up to 300 and randomly selected from the eligible population. Licensed premises were randomly assigned by computer to intervention and control arms in a 1 : 1 ratio. Optimal allocation was used, stratified by LA. Premises opening hours, volume of previous violence and LA EHP capacity were used to balance the randomisation. Premises were dropped from the study if they were closed at the time of audit.ResultsSMILE was delivered with high levels of reach and fidelity but similar levels of dose to all premises, regardless of risk level. Intervention premises (n = 208) showed an increase in police-recorded violence compared with control premises (n = 245), although results are underpowered. An initial risk audit was less effective than normal practice (hazard ratio = 1.34, 95% confidence interval 1.20 to 1.51) and not cost-effective. Almost all eligible intervention premises (98.6%) received the initial risk audit; nearly 40% of intervention practices should have received follow-up visits but fewer than 10% received one. The intervention was acceptable to EHPs and to some premises staff, but less so for smaller independent premises.ConclusionsSMILE was associated with an increase in police-recorded violence in intervention premises, compared with control premises. A lack of follow-up enforcement visits suggests implementation failure for what was seen as a key mechanism of action. There are also concerns as to the robustness of police data for targeting and assessing outcome effectiveness, while intervention premises may have received greater attention from statutory agencies and, therefore, the identification of more violence than control premises. Although SMILE had high reach and was feasible and acceptable to EHPs, it was found to be ineffective and associated with increased levels of violence, compared with normal practice and it requires additional work to promote the implementation of follow-up enforcement visits. Future work will aim to better understand the role of intervention dose on outcomes and seek more objective measures of violence for use in similar trials.Trial registrationCurrent Controlled Trials ISRCTN78924818.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 10. See the NIHR Journals Library website for further project information.

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Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

BMC Psychiatry ◽

10.1186/s12888-021-03280-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Roya Rahimi ◽

Shirin Hasanpour ◽

Mojgan. Mirghafourvand ◽

Khalil Esmaeilpour

Keyword(s):

Mental Health ◽

Confidence Interval ◽

Group Counseling ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

The Mean ◽

And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

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Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽

10.1161/circ.125.suppl_10.ap186 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jaime Céspedes ◽

German Briceño ◽

Michael Farkouh ◽

Rajesh Vedanthan ◽

Martha Leal ◽

...

Keyword(s):

Educational Intervention ◽

Cardiovascular Health ◽

Controlled Trial ◽

Intervention Group ◽

Educational Programs ◽

Control Group ◽

Active Lifestyle ◽

And Control ◽

The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

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An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

Public Health Research ◽

10.3310/phr08070 ◽

2020 ◽

Vol 8 (7) ◽

pp. 1-156

Author(s):

Joanne L Clarke ◽

Jenny Ingram ◽

Debbie Johnson ◽

Gill Thomson ◽

Heather Trickey ◽

...

Keyword(s):

Public Health ◽

Randomised Controlled Trial ◽

Infant Feeding ◽

Health Research ◽

Controlled Trial ◽

Intervention Group ◽

Public Health Research ◽

Breastfeeding Initiation ◽

Before And After ◽

Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

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Effect of a Sleep Hygiene Education Program Using Telephone Follow-up Method on the Sleep Quality of the Elderly

Salmand ◽

10.32598/sija.15.4.2895.1 ◽

2021 ◽

Vol 15 (4) ◽

pp. 484-495

Author(s):

Maryam Moradi ◽

◽

Hamideh Mohammadzadeh ◽

Reza Noori ◽

Kokab Basiri Moghadam ◽

...

Keyword(s):

Sleep Quality ◽

Education Program ◽

Intervention Group ◽

The Elderly ◽

Sleep Hygiene ◽

Control Group ◽

Hygiene Education ◽

And Control

Objectives: Low quality sleep is one of the most common problems in old age. The present study aims to determine the effect of a sleep hygiene education program using Telephone Follow-Up (TFU) method on the sleep quality of the elderly. Methods & Materials: This quasi-experimental study was conducted on 80 eligible elderly people aged 60-74 years who were selected using a systematic random sampling method and were randomly assigned into intervention and control groups. The intervention group received a one-hour face-to-face education session on sleep hygiene. The TFU were carried out two times per week in the first month and once a week in the second month after intervention. The control group received routine care. The data collection tools were a demographic form and the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The PSQI was completed for both groups immediately after the second month. Results: There was no statistically significant difference in the mean PSQI score before intervention in the intervention (8.02) and control (7.47) groups (P=0.32), but after the intervention, the mean PSQI score in the intervention group (5.42) was significantly reduced compared to the control group (7.67) (P<0.001). Conclusion: Sleep hygiene education program based on TFU improves the sleep quality of the elderly. It is recommended that health care providers use this method to improve the sleep quality of the elderly.

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Long-term weight loss following a randomised controlled trial of a weight management programme for men delivered through professional football clubs: the Football Fans in Training follow-up study

Public Health Research ◽

10.3310/phr06090 ◽

2018 ◽

Vol 6 (9) ◽

pp. 1-114 ◽

Cited By ~ 7

Author(s):

Cindy M Gray ◽

Sally Wyke ◽

Rachel Zhang ◽

Annie S Anderson ◽

Sarah Barry ◽

...

Keyword(s):

Public Health ◽

Weight Loss ◽

Health Research ◽

Controlled Trial ◽

Intervention Group ◽

Medical Record Linkage ◽

Football Clubs ◽

Portion Sizes

Background Rising levels of obesity require interventions that support people in long-term weight loss. The Football Fans in Training (FFIT) programme uses loyalty to football teams to engage men in weight loss. In 2011/12, a randomised controlled trial (RCT) found that the FFIT programme was effective in helping men lose weight up to 12 months. Objectives To investigate the long-term weight, and other physical, behavioural and psychological outcomes up to 3.5 years after the start of the RCT; the predictors, mediators and men’s qualitative experiences of long-term weight loss; cost-effectiveness; and the potential for long-term follow-up via men’s medical records. Design A mixed-methods, longitudinal cohort study. Setting Thirteen professional Scottish football clubs from the RCT and 16 additional Scottish football clubs that delivered the FFIT programme in 2015/16. Participants A total of 665 men who were aged 35–65 years at the RCT baseline measures and who consented to follow-up after the RCT (intervention group, n = 316; comparison group, n = 349), and 511 men who took part in the 2015/16 deliveries of the FFIT programme. Interventions None as part of this study. Main outcome measures Objectively measured weight change from the RCT baseline to 3.5 years. Results In total, 488 out of 665 men (73.4%) attended 3.5-year measurements. Participants in the FFIT follow-up intervention group sustained a mean weight loss from baseline of 2.90 kg [95% confidence interval (CI) 1.78 to 4.02 kg; p < 0.001], and 32.2% (75/233) weighed ≥ 5% less than at baseline. Participants in the FFIT follow-up comparison group (who participated in routine deliveries of the FFIT programme after the RCT) lost a mean of 2.71 kg (95% CI 1.65 to 3.77 kg; p < 0.001), and 31.8% (81/255) achieved ≥ 5% weight loss. Both groups showed long-term improvements in body mass index, waist circumference, percentage body fat, blood pressure, self-reported physical activity (PA) (including walking), the consumption of fatty and sugary foods, fruit and vegetables and alcohol, portion sizes, self-esteem, positive and negative affect, and physical and mental health-related quality of life (HRQoL). Mediators included self-reported PA (including walking) and sitting time, the consumption of fatty and sugary foods and fruit and vegetables, portion sizes, self-esteem, positive affect, physical HRQoL, self-monitoring of weight, autonomous regulation, internal locus of control, perceived competence, and relatedness to other FFIT programme participants and family members. In qualitative interviews, men described continuing to self-monitor weight and PA. Many felt that PA was important for weight control, and walking remained popular; most were still aware of portion sizes and tried to eat fewer snacks. The FFIT programme was associated with an incremental cost-effectiveness of £10,700–15,300 per quality-adjusted life-year (QALY) gained at 3.5 years, and around £2000 per QALY gained in the lifetime analysis. Medical record linkage provided rich information about the clinical health outcomes of the FFIT RCT participants, and 90% of men (459/511) who took part in the 2015/16 FFIT programme gave permission for future linkage. Conclusions Participation in the FFIT programme under both research (during the FFIT RCT) and routine (after the FFIT RCT) delivery conditions led to significant long-term weight loss. Further research should investigate (1) how to design programmes to improve long-term weight loss maintenance, (2) longer-term follow-up of FFIT RCT participants and (3) very long-term follow-up via medical record linkage. Trial registration Current Controlled Trials ISRCTN32677491. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. 9. See the NIHR Journals Library website for further project information. The Scottish Executive Health Department Chief Scientist Office (CSO) funded the feasibility pilot that preceded the FFIT RCT (CZG/2/504). The Medical Research Council (MRC) funded Kate Hunt and additional developmental research through the MRC/CSO Social and Public Health Sciences Unit Gender and Health programme (5TK50/25605200-68094).

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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

10.21203/rs.3.rs-34762/v1 ◽

2020 ◽

Author(s):

Sepideh Din Mohammadi ◽

Mohsen Dadashi ◽

Elahe Ahmadnia ◽

leila Janani ◽

Roghieh Kharaghani

Keyword(s):

Quality Of Life ◽

At Risk ◽

Domestic Violence ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Solution Focused

Abstract Background: Domestic violence is considered as one of the most common social problems, which can affect the quality of life of women. The problem of preventing and controlling this problem, especially during pregnancy, is one of the basic challenges of health systems. The aim of this study was to determine the effect of counseling based on conflict solution on the rate of violence and quality of life of pregnant women at risk of domestic violence. Methods: This study was a randomized controlled trial on 90 pregnant women, who were selected from maternity wards in health center number three in Zanjan city. Women who had inclusion criteria based on the domestic violence conflict tactics scale (CTS-2) selected with convenience sampling and randomly divided into two groups of intervention (45 people) and control (45 people) with a blocked randomization method. The intervention group received six counseling sessions with a solution-focused approach and the control group received no intervention. Study tool included demographic and reproductive questionnaires CTS- 2 and short form health survey (SF-36); which completed at baseline and six weeks follow-up in both groups. The results were analyzed by nonparametric ANCOVA using SPSS and R soft wares.Results: The results showed that there was a significant difference in the physical violence (P=0.001), psychological violence (P=0.001), and sexual violence (P=0.001) in the intervention group compared to the control group at six weeks follow- up. There were significant improvements in negotiation scores in the intervention group (P˂0.001). Moreover, there were significant differences in the quality of life scores (P=0.001), vitality (p=0.003), psychological health (p=0.004), bodily pain (p=0.014), physical functioning (p=0.023), and social functioning (p=0.019) between the two groups at the follow- up period.Conclusion: According to the result, individual counseling based on a solution-based approach reduces the amount of domestic violence and increases the quality of life of pregnant women at risk of violence.Trial registration: Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

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Diet quality from pre-school to school age in Brazilian children: a 4-year follow-up in a randomised control study

British Journal Of Nutrition ◽

10.1017/s0007114513002857 ◽

2013 ◽

Vol 111 (3) ◽

pp. 499-505 ◽

Cited By ~ 17

Author(s):

Fernanda Rauber ◽

Daniel J. Hoffman ◽

Márcia Regina Vitolo

Keyword(s):

Diet Quality ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Saturated Fat ◽

Healthy Eating Index ◽

Control Group ◽

School Age

A previous study demonstrated that dietary counselling for mothers during the first year of life improved overall diet quality of children at pre-school age in a low-income population. Thus, the objective of the present study was to assess the long-term effect of this intervention on diet quality of children at school age and examine the tracking of dietary intake throughout childhood. The present study was a follow-up of a randomised controlled trial with children who were assessed at 3–4 years (n 345) and 7–8 years (n 307) of age. We collected two 24 h dietary recalls and assessed diet quality using the Healthy Eating Index (HEI). Analyses were performed by group using a paired t test and a Student's t test for independent samples. Diet quality did not differ between the intervention and control groups at 7–8 years of age (HEI score 65·2 (sd 9·5) v. 64·9 (sd 8·5)). Regarding changes in diet quality from pre-school to school age, we observed the tracking of diet quality in the control group and the loss of the intervention effect in the intervention group. In both groups, the score for fruit and milk intake decreased, while that for saturated fat and dietary variety intake increased. The score for the intakes of grains, meat and legumes, and total fat remained constant for all children. The present data provide evidence that diet quality tracks during childhood since the total HEI score did not differ over time in the control group. The decrease in score for some HEI components did not affect the overall diet quality due to the increase in score for other HEI components.

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A coaching program to improve quality of life in older people in Japan: a randomised controlled trial

British Journal of Community Nursing ◽

10.12968/bjcn.2019.24.7.315 ◽

2019 ◽

Vol 24 (7) ◽

pp. 315-322

Author(s):

Junko Ohashi ◽

Toshiki Katsura

Keyword(s):

Quality Of Life ◽

Older People ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Improve Quality ◽

Public Attention ◽

Randomised Controlled ◽

Geriatric Center

As the world's population ages, efforts to improve quality of life (QOL) in old age are gaining public attention. In this study, a programme was conducted for older people with the aim of clarifying their life goals related to QOL and the meaning of their existence, and the effect of the programme in improving QOL was evaluated. Participants were randomly assigned to the intervention or control group after registration. The program consisted of four 90-minute classes. The primary outcome was the Philadelphia Geriatric Center Morale Scale score (PGC), and changes in outcomes were compared between groups. The intervention group had significantly improved PGC scores (P<0.003). Further, the scores of PGC subscales ‘Acceptance of one's own ageing’ and ‘Lonely dissatisfaction’ showed significant improvements after the intervention (P<0.001). The findings suggest the effectiveness of the developed program in improving QOL in people aged ≥65 years.

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