Effectiveness of a complex, pre-conception intervention to reduce the risk of diabetes by reducing adiposity in young adults in Malaysia: The Jom Mama project - A randomised controlled trial.

Background: Pre-conception interventions have the potential to lower non-communicable disease risk in prospective parents and reduce transmission of risk factors such as obesity to the next generation. The Jom Mama project in Malaysia investigated the effectiveness of a combined behaviour change communication and e-health intervention in young married couples prior to first pregnancy. This paper reports the evaluation of the effectiveness of this trial. Methods: Jom Mama was a non-blinded, randomised controlled trial (RCT) conducted in Seremban, Malaysia, over a period of 33 weeks, covering six contact points between trained community health workers and newly married couples before the conception of a first child. Out of 2075 eligible nulliparous women, 549 participated and 305 completed the intervention, with 145 women in the intervention and 160 in the control group. The intervention group received a complex behavioural change intervention, combining behaviour change communication provided by community health promoters and access to a habit formation mobile application, while the control group received the standard care provided by public health clinics in Malaysia. The primary outcome was a change in the woman's waist circumference. Secondary outcomes were anthropometric and metabolic measures, dietary intake (Food Frequency Questionnaire, FFQ), physical activity (International Physical Activity Questionnaire, IPAQ) and mental health (Depression Anxiety Stress Scale, DASS 21). An extensive process evaluation was conducted alongside the trial in order to aid the interpretation of the main findings. Results: There were no significant differences of change in the woman's waist circumference between intervention and control groups at the start and end of the intervention. While the weight, waist circumference and Body Mass Index (BMI) of women in both groups increased, there was a significantly lower increase in the intervention vs the control group over the period of the trial among women who are obese (0.1 kg vs 1.7 kg; P = 0.023, in the intervention and control group respectively). In terms of BMI, the obese intervention subgroup showed a slight reduction (0.01) compared to the obese control subgroup whose BMI increased by 0.7 (P = 0.015). There were no changes in the other secondary outcomes. Conclusions: The Jom Mama pre-conception intervention did not lead to a reduction in waist circumference or significant changes in other secondary outcomes over the eight months prior to conception. However, there was a significantly smaller weight gain in the intervention vs the control group, predominantly in women with pre-existing obesity.

Effect of locally produced complementary foods on fat-free mass, linear growth, and iron status among Kenyan infants: A randomized controlled trial.

The impact of quality complementary food products on infant growth and body composition has not been adequately investigated. This study evaluated the effect on fat-free mass (FFM) accrual, linear growth, and iron status of locally produced complementary food products comparing to a standard product. In a randomized, double-blind trial, 499 infants at 6 months received nine monthly rations of (a) WinFood Classic (WFC) comprising germinated amaranth (71%), maize (10.4%), small fish (3%), and edible termites (10%); (b) WinFood Lite (WFL) comprising germinated amaranth (82.5%), maize (10.2%), and multimicronutrient premix; or (c) fortified corn-soy blend plus (CSB+). Primary outcomes were changes in FFM, length, and plasma ferritin and transferrin receptors (TfR). FFM was determined using deuterium dilution. Analysis was by intention to treat, based on available cases. Compared with CSB+, there were no differences in change from 6 to 15 months in FFM for WFC 0.0 kg (95% CI [-0.30, 0.29]) and WFL 0.03 kg (95% CI [-0.25, 0.32]) and length change for WFC -0.3 cm (95% CI [-0.9, 0.4]) and WFL -0.3 cm (95% CI [-0.9, 0.3]). TfR increased in WFC group 3.3 mg L-1 (95% CI [1.7, 4.9]) and WFL group 1.7 mg L-1 (95% CI [0.1, 3.4]) compared with CSB+. Compared with the increase in Hb in CSB+ group, there was a reduction in Hb in WFC of -0.9 g dl-1 (95% CI [-1.3, -0.5]) and a lower increase in WFL -0.4 g dl-1 (95% CI [-0.8, 0.0]). In conclusion, the tested WinFoods had the same effect on FFM and length as CSB+, whereas Hb and iron status decreased, suggesting inhibited iron bioavailability from the amaranth-based WinFoods.

Stunting, wasting and breast-feeding as correlates of body composition in Cambodian children at 6 and 15 months of age.

The study aimed at assessing stunting, wasting and breast-feeding as correlates of body composition in Cambodian children. As part of a nutrition trial (ISRCTN19918531), fat mass (FM) and fat-free mass (FFM) were measured using 2H dilution at 6 and 15 months of age. Of 419 infants enrolled, 98 % were breastfed, 15 % stunted and 4 % wasted at 6 months. At 15 months, 78 % were breastfed, 24 % stunted and 11 % wasted. Those not breastfed had lower FMI at 6 months but not at 15 months. Stunted children had lower FM at 6 months and lower FFM at 6 and 15 months compared with children with length-for-age z ≥0. Stunting was not associated with height-adjusted indexes fat mass index (FMI) or fat-free mass index (FFMI). Wasted children had lower FM, FFM, FMI and FFMI at 6 and 15 months compared with children with weight-for-length z (WLZ) ≥0. Generally, FFM and FFMI deficits increased with age, whereas FM and FMI deficits decreased, reflecting interactions between age and WLZ. For example, the FFM deficits were -0·99 (95 % CI -1·26, -0·72) kg at 6 months and -1·44 (95 % CI -1·69; -1·19) kg at 15 months (interaction, P<0·05), while the FMI deficits were -2·12 (95 % CI -2·53, -1·72) kg/m2 at 6 months and -1·32 (95 % CI -1·77, -0·87) kg/m2 at 15 months (interaction, P<0·05). This indicates that undernourished children preserve body fat at the detriment of fat-free tissue, which may have long-term consequences for health and working capacity.

Effect of complementary food with small amounts of freshwater fish on whole blood n-3 fatty acids in Cambodian infants age 6-15 months.

The impact of freshwater fish consumption on the status of long-chain n-3 fatty acids (n-3 LCPUFA) in infants in landlocked, low-income populations is unknown. We used secondary data from a randomized, single-blinded, controlled trial to evaluate the impact of daily consumption of complementary food products with small amounts of freshwater fish on whole blood n-3 LCPUFA in Cambodian infants. Infants (n = 419), received daily, one of four food products for 9 months. Two products contained freshwater fish: WinFood (10% fish by dry weight) and WinFood-L (12% fish by dry weight), while two products were non-fish-based: corn-soy blends (CSB+ and CSB++). Whole blood fatty acids and breastfeeding status were assessed at baseline and endline of the intervention. The WinFood products contributed to an estimated maximum intake of 86.5 mg/day n-3 LCPUFA. There was no difference in whole blood n-3 LCPUFA among the four intervention groups or between the fish-based and the non-fish-based groups (p ≥ 0.142). At endline, 71% of the children were still breastfed. Interaction analyses indicated a lower ratio of n-6/n-3 PUFA in non-breastfed infants in the WinFood groups compared to the CSB groups (pinteraction = 0.026). Thus, a high intake of n-3 LCPUFA from breastmilk may have blurred a potential impact of small amounts of freshwater fish effect on n-3 LCPUFA status in Cambodian infants.

Pre-pregnancy community-based intervention for couples in Malaysia: application of intervention mapping.

BACKGROUND: Malaysia is experiencing a nutrition transition with burgeoning obesity, particularly in women, and a growing prevalence of non-communicable disease. These health burdens have severe implications not only for adult health but also across generations. Pre-conception health promotion could address the intergenerational risk of metabolic disease. This paper describes the development of the "Jom Mama" intervention using Intervention Mapping (IM). The Jom Mama intervention aims to improve the health of young adult couples in Malaysia prior to conception. METHODS: IM comprises of five steps prior to the last one, which involves the evaluation of the intervention. We used the five steps to develop the Jom Mama intervention. RESULTS: Both the process and evidence is documented providing the rationale to the selection of the key objectives of the intervention: (i) increasing healthy dietary practice; (ii) increasing physical activity levels, (iii) reducing sedentary activity; and (iv) improving social support to offset stressful lifestyles. From the IM process, Jom Mama will be health-system centred approach that uniquely combines both community health promoters and an electronic-health platform to deliver the complex intervention. CONCLUSION: IM is an iterative process that systematically gathers "best" evidence, selects appropriate theories of behaviour change, and facilitates formative research so as to develop a complex intervention. Though the IM process is time consuming, complex, and costly, it has enriched the Jom Mama intervention with a number of notable advantages: (i) intervention fashioned on formative work with stakeholders and in the target group; (ii) intervention combines research evidence with theory; (iii) intervention acknowledges multiple dynamics of influence; and (iv) intervention is embedded within health service priorities in Malaysia for greater scale-up possibility.

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

BACKGROUND: Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. METHOD/DESIGN: Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14-904-21963) on 21 September 2015. DISCUSSION: This study protocol describes the first community-based randomised controlled trial, to examine the efficacy of a complex intervention in improving the pre-pregnancy health of young Malaysian women and their spouses. Results from this trial will contribute to improve policy and practices regarding complex behavioural change interventions to prevent diabetes in the pre-conception period in Malaysia and other low- and middle-income country settings. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov) on 30 November 2015, Identifier: NCT02617693 .

WinFood data from Kenya and Cambodia: constraints on field procedures.

BACKGROUND: Researchers face myriad challenges in the design and implementation of randomized, controlled trials. Apart from summaries on limitations, these challenges are rarely documented in detail to inform future research projects. OBJECTIVE: To describe methodological challenges encountered during randomized, controlled trials (WinFood Study) designed to assess the efficacy of locally produced complementary foods based on traditional animal-source foods (edible termites and spiders) to support growth and nutritional status in Kenyan and Cambodian infants. METHODS: In a randomized, controlled design, infants received WinFood or corn-soy blend (CSB) for 9 months from 6 to 15 months of age. Lean mass accrual and blood nutrition indicators (lipid profile, iron and zinc status) were measured cross-sectionally at 9 and 15 months of age, respectively. Lean mass was determined by measuring deuterium oxide enrichment in saliva samples following a standard dose of deuterium solution (0.5 g/kg body weight) to infants. Blood nutrition indicators were determined following the drawing of 3 mL of blood by venipuncture. RESULTS: Challenges included rapid depletion of food rations, high rate of loss to follow-up, delayed ethical approval, lack of local food-processing capacity, low capacity among staff to draw blood, and lack of laboratory capacity to perform both deuterium oxide and micronutrient status measurements. Spillage of deuterium oxide solution during dosing was a major challenge in the Kenya context. A high rate of morbidity among infants made some assessments very difficult, especially drawing of blood and saliva samples. CONCLUSIONS: The challenges were largely contextual. Improvement of local laboratory capacity, training of staff and sensitization of the communities and the Ethics Review Committee are highly recommended.

Effects of animal source food and micronutrient fortification in complementary food products on body composition, iron status, and linear growth: a randomized trial in Cambodia.

BACKGROUND: Poor nutritional quality of complementary foods often limits growth. Animal source foods, such as milk or meat, are often unaffordable. Local affordable alternatives are needed. OBJECTIVE: We evaluate the efficacy of 2 newly developed, rice-based complementary food products: WinFood (WF) with small fish and edible spiders and WinFood-Lite (WF-L) fortified with small fish, against 2 existing fortified corn-soy blend products, CSB+ (purely plant based) and CSB++ (8% dried skimmed milk). DESIGN: In total, 419 infants aged 6 mo were enrolled in this randomized, single-blinded study for 9 mo, designed primarily to assess increments in fat-free mass by a deuterium dilution technique and change in plasma ferritin and soluble transferrin receptor. Secondary endpoints were changes in anthropometric variables, including knee-heel length. Data were analyzed by the intention-to-treat approach. RESULTS: There was no difference in fat-free mass increment in WF or WF-L compared with CSB+ [WF: +0.04 kg (95% CI: -0.20, 0.28 kg); WF-L: +0.14 kg (95% CI: -0.10, 0.38 kg)] or CSB++ [WF: -0.03 kg (95% CI: -0.27, 0.21 kg); WF-L: +0.07 kg (95% CI: -0.18, 0.31 kg)] and no effect on iron status. The 1.7-mm (95% CI: -0.1, 3.5 mm) greater increase in knee-heel length in WF-L than in CSB+ was not significant. CONCLUSIONS: No difference was found between the locally produced products (WF and WF-L) and the CSBs. Micronutrient fortification may be necessary, and small fish may be an affordable alternative to milk to improve complementary foods. The dietary role of edible spiders needs to be further explored. This trial was registered at controlled-trials.com as ISRCTN19918531.

The use of linear programming to determine whether a formulated complementary food product can ensure adequate nutrients for 6- to 11-month-old Cambodian infants.

BACKGROUND: A new software tool, Optifood, developed by the WHO and based on linear programming (LP) analysis, has been developed to formulate food-based recommendations. OBJECTIVE: This study discusses the use of Optifood for predicting whether formulated complementary food (CF) products can ensure dietary adequacy for target populations in Cambodia. DESIGN: Dietary data were collected by 24-h recall in a cross-sectional survey of 6- to 11-mo-old infants (n = 78). LP model parameters were derived from these data, including a list of foods, median serving sizes, and dietary patterns. Five series of LP analyses were carried out to model the target population's baseline diet and 4 formulated CF products [WinFood (WF), WinFood-Lite (WF-L), Corn-Soy-Blend Plus (CSB+), and Corn-Soy-Blend Plus Plus (CSB++)], which were added to the diet in portions of 33 g/d dry weight (DW) for infants aged 6-8 mo and 40 g/d DW for infants aged 9-11 mo. In each series of analyses, the nutritionally optimal diet and theoretical range, in diet nutrient contents, were determined. RESULTS: The LP analysis showed that baseline diets could not achieve the Recommended Nutrient Intake (RNI) for thiamin, riboflavin, niacin, folate, vitamin B-12, calcium, iron, and zinc (range: 14-91% of RNI in the optimal diets) and that none of the formulated CF products could cover the nutrient gaps for thiamin, niacin, iron, and folate (range: 22-86% of the RNI). Iron was the key limiting nutrient, for all modeled diets, achieving a maximum of only 48% of the RNI when CSB++ was included in the diet. Only WF and WF-L filled the nutrient gap for calcium. WF-L, CSB+, and CSB++ filled the nutrient gap for zinc (9- to 11-mo-olds). CONCLUSIONS: The formulated CF products improved the nutrient adequacy of complementary feeding diets but could not entirely cover the nutrient gaps. These results emphasize the value of using LP to evaluate special CF products during the intervention planning phase. The WF study was registered at controlled-trials.com as ISRCTN19918531.

[Health status and degree of traumatisation among newly arrived asylum seeker--secondary publication]. / Nyankomne asylansøgeres helbredsstatus og traumatiseringsgrad--sekundaerpublikation.

An unknown number of asylum seekers arriving in Denmark have been exposed to torture. Amnesty International's Danish Medical Group examined 142 asylum seekers, of whom 45% had been exposed to torture. Physical and psychological symptoms were 2-3 times as frequent among torture survivors as among non-tortured asylum seekers. Among the torture survivors, 63% fulfilled the criteria of post-traumatic stress disorder, 58% had objective psychological findings, and 42% had torture-related scars. Identification of torture survivors is important in order to initiate the necessary medical treatment.

[Undernutrition in humanitarian crises]. / Underernaering ved humanitaere kriser.

Undernutrition is a major cause of morbidity and mortality in emergencies. The response depends on the extent and type of undernutrition in the affected population. Nutritional status is assessed by weight-for-height, mid-upper arm circumference and micronutrient deficiencies. Food aid is distributed in general or selective feeding programmes. Promotion of breastfeeding has been found to be one of the most efficient strategies to prevent undernutrition. There is a lack of evidence to support the optimal composition of food aid products, but there is an increasing focus on the importance of research in this field.

An international review of projects on hospital performance assessment.

BACKGROUND: Assessing the quality of health care has become increasingly important in health care in response to growing demands from purchasers, providers, clinicians and the public. Given the increase in projects and programs to assess performance in health care in the last 15 years, the purpose of this paper is to review current indicator projects for hospital performance assessment and compare them to the Performance Assessment Tool for Quality Improvement in Hospitals (PATH), an initiative by the WHO Regional Office for Europe. METHODOLOGY: We identified current indicator projects through a systematic literature search and through contact with experts. Using an inductive approach based on a review of the literature, we identified 10 criteria for the comparison of indicator projects. We extracted data and contacted the coordinators of each indicator project to validate this information. In addition, we carried out interviews with coordinators to gather additional information on the evaluation of the respective projects. RESULTS: We included 11 projects that appear to have adopted a common methodology for the design and selection of indicators; however, major differences exist with regard to the philosophy, scope and coverage of the projects. This relates in particular to criteria such as participation, disclosure of results and dimensions of hospital performance assessed. CONCLUSION: Hospital performance assessment projects have become common worldwide, and initiatives such as the WHO PATH project need to be well coordinated with existing projects. Our review raised questions regarding the impact of hospital performance assessment that should be pursued in further research.

Asylum seekers in Denmark--a study of health status and grade of traumatization of newly arrived asylum seekers.

BACKGROUND: An unknown number of asylum seekers arriving in Denmark have been exposed to torture or have experienced other traumatising events in their country of origin. The health of traumatised asylum seekers, both physically and mentally, is affected upon arrival to Denmark, and time in asylum centres leads to further deterioration in health. METHODS: One hundred forty-two (N=142) newly arrived asylum seekers were examined at Center Sandholm by Amnesty International Danish Medical Group from the 1st of September until the 31st of December 2007. FINDINGS: The asylum seekers came from 33 different countries, primarily representing Afghanistan, Iraq, Iran, Syria, and Chechnya. Of the asylum seekers, 45 percent had been exposed to torture--approximately one-third within the year of arrival to Denmark. Unsystematic blows, personal threats or threats to family, degrading treatment, isolation, and witnessing torture of others were the main torture methods reported. The majority of the asylum seekers had witnessed armed conflict, persecution, and imprisonment. The study showed that physical symptoms were approximately twice as frequent and psychological symptoms were approximately two to three times as frequent among torture survivors as among non-tortured asylum seekers. However, even the health of non-tortured asylum seekers was affected. Among the torture survivors, 63 percent fulfilled the criteria for post-traumatic stress disorder, and 30-40 percent of the torture survivors were depressed, in anguish, anxious, and tearful in comparison to 5-10 percent of the non-tortured asylum seekers. Further, 42 percent of torture survivors had torture-related scars. INTERPRETATION: Torture survivors amid newly arrived asylum seekers are an extremely vulnerable group, hence examination and inquiry about the torture history is extremely important in order to identify this population to initiate the necessary medical treatment and social assistance. Amnesty International Danish Medical group is currently planning a follow-up study of the present population which will focus on changes in health status during their time in Denmark.