Effect of supervised group Exercise on psychological WEll-being among pregnant women with or at high risk of depression (the EWE Study): a randomised controlled trial

IntroductionMillions of children in low resource settings are at high risk of poor development due to factors such as under nutrition, inadequate stimulation and maternal depression. Evidence-based interventions to address these risk factors exist, but often as a separate and overlapping package. The current study aims to evaluate the effectiveness of a common elements-based intervention to improve mother–infant interaction at 12 months post-partum.Method and analysisA two-arm, single-blinded, individual randomised controlled trial is being carried out in the community settings of the rural subdistrict of Gujar Khan in Rawalpindi, Pakistan. 250 pregnant women in third trimester with distress (Self-Reporting Questionnaire, cut-off score >9) have been randomised on 1:1 allocation ratio into intervention (n=125) and treatment-as-usual arms (n=125). The participants in the intervention arm will receive 15 individual sessions of intervention on a monthly basis by non-specialist facilitators. The intervention involves components of early stimulation, learning through play, responsive feeding, guided discovery using pictures, behavioural activation and problem solving. The primary outcome is caregiver–infant interaction at 12 months postpartum. The secondary outcomes include maternal psychological well-being, quality of life, social support and empowerment. Infant secondary outcomes include growth, nutrition and development. The data will be collected at baseline, 6 and 12 months postpartum. A qualitative process evaluation will be conducted to inform the feasibility of intervention delivery.EthicsEthics approval for the present study was obtained from the Human Development Research Foundation Institutional Review Board, Islamabad Pakistan.DisseminationIf proven effective, the study will contribute to scale-up care for maternal and child mental health in low resource settings, globally. The findings of the present study will be published in peer-reviewed journals and presented at conferences and community forums.Trial registration numberNCT04252807.

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Respond to “Comment on - Effects of family participatory dignity therapy on the psychological well-being and family function of patients with hematologic malignancies and their family caregivers: A randomised controlled trial”

International Journal of Nursing Studies ◽

10.1016/j.ijnurstu.2021.103965 ◽

2021 ◽

pp. 103965

Author(s):

Chunfeng Wang ◽

Yong Wu ◽

Rong Hu

Keyword(s):

Randomised Controlled Trial ◽

Family Caregivers ◽

Controlled Trial ◽

Well Being ◽

Hematologic Malignancies ◽

Psychological Well Being ◽

Family Function ◽

Dignity Therapy ◽

Randomised Controlled

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SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial

Frontiers in Global Women's Health ◽

10.3389/fgwh.2021.620759 ◽

2021 ◽

Vol 2 ◽

Author(s):

Shobhana Nagraj ◽

Stephen H. Kennedy ◽

Vivekananda Jha ◽

Robyn Norton ◽

Lisa Hinton ◽

...

Keyword(s):

Decision Support ◽

Pilot Study ◽

High Risk ◽

Randomised Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Rural India ◽

Cluster Randomised ◽

Randomised Controlled

Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy.Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods.Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03968952.

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