Clinical Research Directory

Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan

Early life nutrition is the key modifiable determinant of child growth, development, survival and diseases of adult onset. Pakistan ranks highest for neonatal mortality rate (44.2/1000 live births (LBs)) globally. One third of under-five deaths (74.9/1000 LBs) are attributable to high prevalence of stunting (38%), underweight (23%) and wasting (7%), greatly related to feeding practices. Given the low prevalence of exclusively breast fed (EBF) (48%) and use of minimum acceptable diet (13%), mitigation of early life nutritional risk through promotion of EBF and Young Child Feeding Practices (YCFP) provides a critical window of opportunity for intervention. Secondary Care Hospitals (SCH) of the Aga Khan Health Services Pakistan provide essential maternal and child health services for low-middle income population. Babies born at these SCHs are followed up for vaccination, growth-monitoring and other services at the closely affiliated Family Health Centers (FHCs) run by Lady Health Visitors (LHVs). We aim to examine the effectiveness of a locally designed m-Health application for empowering mothers for child nutritional care as a potentially sustainable approach. The first six months of formative research would identify perceptions, barriers and facilitators for EBF and YCFP using self-determination behavioral theory, among multi-parous pregnant mothers enrolled at three SCHs of Karachi. A randomization trial would be conducted during next 18 months among near-term pregnant women who have access to smart-phones. A culturally appropriate mhealth application called first diet would be developed to provide personalized push messages delivered weekly by the LHVs. Non-intervention group will receive face-face nutritional counselling by the research staff at FHC following routine vaccination and growth-monitoring schedule. Mothers would followed-up from one month prior to expected delivery to child's first birthday. We expect 20% improvement in rates of EBF and YCFP with m-Health intervention. If proven effective, m-health would be incorporated in routine child care provision by LHVs.

Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (Full Scale Trial)

A 1:1:1 individually randomized unmasked controlled trial is proposed in which caregivers will be trained to screen their children who have recovered from an episode of SAM (severe acute malnutrition) using MUAC (mid-upper arm circumference) tapes. One arm will include caregiver screening with a mid-upper arm circumference tape and usual monthly follow-up schedule for the first 3 months post enrollment and a final follow-up at 6 months. Another arm will include caregiver screening with a mid-upper arm circumference tape and a reduced follow-up schedule for one visit at 3 months and a final visit at 6 months. The third arm will adhere to the current standard of care, which is no caregiver training to conduct mid-upper arm circumference screenings and monthly clinic-based follow-up appointments for 3 months with a final visit at 6 months post enrollment. Children aged 6-54 months with a documented recovery from uncomplicated severe acute malnutrition that was managed in a participating outpatient nutritional program and their caregivers will be eligible for inclusion in the trial. Caregivers will be trained to screen their children weekly for 6 months following discharge from the nutritional program and will be counseled to bring their child back to the nutritional program should their mid-upper arm circumference value fall in the red zone of the mid-upper arm circumference tape (\< 11.5 cm). All children will be seen at 3 and 6 months for the primary outcome assessment. By conducting this study, our primary goal is to determine if training caregivers to screen their children for relapse to MAM (moderate acute malnutrition) or SAM (severe acute malnutrition) using mid-upper arm circumference tapes following recovery from SAM (severe acute malnutrition) will reduce the risk of relapse. An additional aim is to assess the level of acceptability of caregivers screening children for malnutrition using mid-upper arm circumference tapes from both a clinic and caregiver perspective.

Slow Introduction of Nutrition for Ill Malnourished Children

The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is: Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase? Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia). Participants will: * Receive one of the lower calorie feeds (F50 or F35) or the standard feed (F75) during their hospital stay. * Be closely monitored for low blood sugar and signs for worsening of clinical symptoms. * Be treated until they are stable and ready to be fed more calories to help them gain weight.

Microbiome and Malnutrition in Pregnancy

This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on pregnant women, 28 years and younger living in the Toronto and greater Toronto area. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. With the hypothesis that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.

Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants

The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants. Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital.