A pragmatic randomized trial to examine the effect of combining healthy diet with mindfulness cognitive therapy to reduce depressive symptoms among university students in a low-resource setting: protocol for the NutriMind Project.

BACKGROUND: Mental health disorders still rank as leading causes of morbidity worldwide despite increasing awareness and improvements in treatment. Notably, low- and middle-income countries like Uganda, are disproportionately affected by such disorders. The burden of depressive symptoms in these countries is particularly high among students, aggravated by poverty, malnutrition, and inadequate public health governance, yet it is clearly under-researched, making it hard to achieve several of UN Sustainability Development Goals. Current treatment options are insufficient to tackle the increased burden of depressive disease. This is more challenging for low-resource regions especially in Sub-Saharan Africa, suggesting the need for alternative treatments that can swiftly be applied if proven effective. The main aim of this randomized controlled trial (RCT) is therefore to examine if a low-cost healthy diet (based on local Ugandan foods) combined with easy-to access mindfulness cognitive therapy can reduce depressive symptoms among university students in Uganda. METHODS: We will recruit female and male students at Makerere University, the largest public university in Uganda, to an open, intention-to-treat, two-armed RCT. Those who score above a predefined threshold on a self-reported assessment of depressive symptoms, measured by the Center for Epidemiological Studies - Depression score (CES-D), are eligible for study inclusion and will be randomized to either an intervention (n = 125) or a control (n = 125) group. The intervention group will receive educational group-based sessions on how to prepare a Mediterranean-type of healthy diet and how to adhere to the principles of mindfulness-based cognitive therapy. Outcome measures include self-reported depression symptoms, quality of life, and dietary intakes. In addition we will perform a cost-effectiveness analysis. The RCT intervention will last 9 months, followed by additional 15 months with regular data collections. DISCUSSION: We here describe a novel approach to treat depressive symptoms among university students living in resource constraint settings, by combining a healthy diet with low threshold psychotherapy. If this intervention succeeds, our project can be viewed as a step towards evidence-based behavior practices for young adults with a common mental disorder (depression) that are beneficial to public mental health initiatives and management. TRIAL REGISTRATION: The RCT is registered in ClinicalTrials.gov (ID: NCT05848973). The date of registration was August 14, 2023.

The association between dietary diversity and development among children under 24 months in rural Uganda: analysis of a cluster-randomised maternal education trial.

OBJECTIVE: To assess the association between dietary diversity and development among children under 24 months in rural Uganda and to establish other factors that could be associated with development among these children. DESIGN: A secondary data analysis of a cluster-randomised controlled maternal education trial (n 511) was conducted on a sub-sample of 385 children. We used adjusted ORs (AORs) to assess the associations of dietary diversity scores (DDS) and other baseline factors assessed at 6-8 months with child development domains (communication, fine motor, gross motor, personal-social and problem solving) at 20-24 months of age. SETTING: Rural areas in Kabale and Kisoro districts of south-western Uganda. PARTICIPANTS: Children under 24 months. RESULTS: After multivariable analysis, DDS at 6-8 months were positively associated with normal fine motor skills development at 20-24 months (AOR = 1·18; 95 % CI 1·01, 1·37; P = 0·02). No significant association was found between DDS and other development domains. Children who were not ill at 6-8 months had higher odds of developing normal communication (AOR = 1·73; 95 % CI 1·08, 2·77) and gross motor (AOR = 1·91; 95 % CI 1·09, 3·36) skills than sick children. Girls had lower odds of developing normal gross motor skills compared with boys (AOR = 0·58; 95 % CI 0·33, 0·98). Maternal/caregiver nutritional education intervention was positively associated with development of gross motor, fine motor and problem-solving skills (P-values < 0·05). CONCLUSIONS: We found an association between child DDS at 6-8 months and improvement in fine motor skills development at 20-24 months. Child illness status, maternal/caregiver nutritional education intervention and sex were other significant baseline predictors of child development at 20-24 months.

The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial.

OBJECTIVE: We examined associations of urine iodide excretion, proxy for iodine intake, with child development and growth. DESIGN: This is a secondary analysis of a 1:1 cluster-randomised trial with a 6-month nutrition/stimulation/hygiene education intervention among mothers of children aged 6-8 months to improve child development and growth. Development was assessed using Bayley Scales of Infant and Toddler Development-III (BSID-III) and Ages and Stages Questionnaire (ASQ), whereas anthropometry was used to assess growth. Urine iodide concentration (UIC) and urine iodide/creatinine ratio (ICR) were measured. SETTING: The current study was conducted in southern Uganda. PARTICIPANTS: We randomly selected 155 children from the 511 enrolled into the original trial and analysed data when they were aged 20-24 and 36 months. RESULTS: Median UIC for both study groups at 20-24 and 36 months were similar (P > 0·05) and within the normal range of 100-199 µg/l (0·79-1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20-24 months. The BSID-III cognitive score was positively associated (P = 0·028) with ICR at 20-24 months in the intervention group. The ASQ gross motor score was negatively associated (P = 0·020) with ICR at 20-24 months among the controls. ICR was not significantly associated with anthropometry in the two study groups at either time-point. CONCLUSIONS: Following the intervention, a positive association was noted between ICR and child's cognitive score at 20-24 months, whereas no positive association with ICR and growth was detected. Iodine sufficiency may be important for child's cognitive development in this setting.

Effects of nutrition and hygiene education on oral health and growth among toddlers in rural Uganda: follow-up of a cluster-randomised controlled trial.

OBJECTIVE: To examine the effect of a nutrition and hygiene education intervention on oral health behaviour and whether early onset of caries was related to child growth in rural Uganda. METHODS: Follow-up study of a cluster-randomised controlled trial conducted between October 2013 and January 2015. Data were available from 399 mother/child pairs (203 in the intervention and 198 in the control group) of the original trial (78%) when the children were 36 months old. Oral health behaviour was evaluated using questionnaires. Photographs of the maxillary anterior teeth were examined for unmistakably carious lesions, and 115 water samples from the study area were analysed for fluoride concentration. RESULTS: The frequency of cleaning of the child's teeth at 36 months was about twice as high in the intervention as in the control group (84.3% vs. 46.6%; P = 0.0001). Cavitated carious lesions occurred more frequently in the control than the intervention group (27.8% vs. 18.2%; P = 0.04). Extraction of 'false teeth' (ebiino), a painful and crude traditional operation, was profoundly reduced in the intervention group (8.9% vs. 24.7%; P = 0.001). There was no evidence of association between the occurrence of caries and child growth. CONCLUSIONS: The education intervention improved oral hygiene practices and reduced the development and progression of caries and extraction of ebiino. Early childhood caries was not clearly associated with child growth.

Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial.

Stunting is associated with impaired cognitive and motor function. The effect of an education intervention including nutrition, stimulation, sanitation, and hygiene on child growth and cognitive/language/motor development, delivered to impoverished mothers in Uganda, was assessed. In a community-based, open cluster-randomized trial, 511 mother/children dyads aged 6-8 months were enrolled to an intervention (n = 263) or control (n = 248) group. The primary outcome was change in length-for-age z-score at age 20-24 months. Secondary outcomes included anthropometry and scores on the 2 developmental scales: Bayley Scales of Infant and Toddler Development-III and the Ages and Stages Questionnaire. There was no evidence of a difference in mean length-for-age z-score at 20-24 months between the 2 study groups: 0.10, 95% CI [-0.17, 0.36], p = .49. The intervention group had higher mean composite development scores than the controls on Bayley Scales of Infant and Toddler Development-III, the mean difference being 15.6, 95% CI [10.9, 20.2], p = .0001; 9.9, 95% CI [6.4, 13.2], p = .0001; and 14.6, 95% CI [10.9, 18.2], p = .0001, for cognitive, language, and motor composite scores, respectively. The mean difference in scores from the Ages and Stages Questionnaire were 7.0, 95% CI [2.9, 11.3], p = .001; 5.9, 95% CI [1.2, 10.3], p = .01; 4.2, 95% CI [1.7, 6.7], p = .001; 8.9, 95% CI [5.3, 12.3], p = .0001; and 4.4, 95% CI [0.0, 8.8], p = .05, for communication, gross motor, fine motor, problem solving, and personal-social development, respectively. The intervention education delivered to mothers promoted early development domains in cognitive, language, and motor development but not linear growth of small children in impoverished rural communities in Uganda. Our study showed that child development may be improved with a relatively low cost intervention strategy. This trial was registered at ClinicalTrials.gov as NCT02098031.

Long-term effects on depressive symptoms among Ugandan mothers - Findings from a follow-up of a cluster-randomized education trial in a rural low-resource setting.

INTRODUCTION: Depression is increasingly affecting mothers in poor countries such as Uganda. Various interventions have been implemented to tackle this problem, but their sustainability is under-researched. Here we present follow-up data on maternal depression six years after a cluster-randomized controlled maternal education trial in rural Uganda. METHODS: The intervention lasted six months and consisted of nutrition, hygiene, sanitation and child stimulation education, delivered to 511 mothers of 6 to 8 months' old children. Six years later we assessed maternal depressive symptoms using two psychometric tools; the Beck Depression Inventory II (BDI-II) and Center for Epidemiologic Studies Depression scale (CESD). RESULTS: For this follow-up study, data was available from 307/511 (60 %) mothers. Intention-to-treat analyses adjusting for clustering showed that the intervention mothers had non-significantly less depression symptoms (absolute score difference - 2; 95 % CI -5 to 0; p = 0.07) on BDI-II, and borderline significantly less depression symptoms (absolute score difference - 3; 95 % CI -5 to 0; p = 0.05) on CES-D compared to the controls. For categorized depression scores, the control mothers had significantly higher proportion of women classified in the worse depression categories for both BDI-II and CESD. We did not find any baseline characteristics associated with maternal depression. LIMITATIONS: The BDI-II and CES-D tools are both self-reported and we cannot rule out the possibility of social desirability bias in reporting of depression symptoms. CONCLUSION: Six years after the maternal education trial, some benefits on maternal mental health were sustained. More studies are warranted on sustainability and scale-up of such interventions.

8-Year Follow-up of a Maternal Education Trial in a Low-Resource Setting.

OBJECTIVES: Nutrition and stimulation interventions promote early childhood development, but little is known about their long-term benefits in low- and middle-income countries. We conducted a follow-up study of a cluster-randomized maternal education trial performed in children aged 6 to 8 months to assess the sustainability of developmental benefits after 8 years. METHODS: The education intervention lasted 6 months and consisted of nutrition, hygiene, sanitation, and child stimulation aspects. We assessed child processing and cognitive abilities using the Kaufman Assessment Battery for Children Second Edition (KABC-II) and attention and inhibitory control using the Test of Variables of Attention after 8 years. The original trial included 511 mother-child pairs (intervention, n = 263; control, n = 248), whereas in the current study, 361 (71%; intervention, n = 185; control, n = 176) pairs were available for analyses. RESULTS: The intervention group scored higher than the controls (all P < .001) on all 5 KABC-II subscales and on the KABC-II global score (mean difference: 14; 95% confidence interval, 12-16; P < .001). For all 5 Test of Variables of Attention variables, the intervention group scored higher than the controls on both the visual and auditory tasks (all P < .05). Because the intervention was delivered as a package, a limitation is that we cannot pinpoint the individual contribution of each component (nutrition, hygiene, and stimulation) to the developmental benefits. CONCLUSIONS: The intervention group consistently scored markedly higher on both neuropsychological tests. Thus, even 8 years after the original maternal education intervention, the developmental benefits that we observed at child age of 1, 2, and 3 years, were sustained.

Cognitive development among children in a low-income setting: Cost-effectiveness analysis of a maternal nutrition education intervention in rural Uganda.

Inadequate nutrition and insufficient stimulation in early childhood can lead to long-term deficits in cognitive and social development. Evidence for policy and decision-making regarding the cost of delivering nutrition education is lacking in low and middle-income countries (LMIC). In rural Uganda, we conducted a cluster-randomized controlled trial (RCT) examining the effect of a maternal nutrition education intervention on developmental outcomes among children aged 6-8 months. This intervention led to significantly improved cognitive scores when the children reached the age of 20-24 months. When considering the potential for this intervention's future implementation, the desired effects should be weighed against the increased costs. This study therefore aimed to assess the cost-effectiveness of this education intervention compared with current practice. Health outcome data were based on the RCT. Cost data were initially identified by reviewing publications from the RCT, while more detailed information was obtained by interviewing researchers involved in processing the intervention. This study considered a healthcare provider perspective for an 18-months' time horizon. The control group was considered as the current practice for the future large-scale implementation of this intervention. A cost-effectiveness analysis was performed, including calculations of incremental cost-effectiveness ratios (ICERs). In addition, uncertainty in the results was characterized using one-way and probabilistic sensitivity analyses. The ICER for the education intervention compared with current practice was USD ($) 16.50 per cognitive composite score gained, with an incremental cost of $265.79 and an incremental cognitive composite score of 16.11. The sensitivity analyses indicated the robustness of these results. The ICER was sensitive to changes in cognitive composite score and the cost of personnel. The education intervention can be considered cost-effective compared with the current practice. The outcome of this study, including the cost analysis, health outcome, cost-effectiveness, and sensitivity analysis, can be useful to inform policymakers and stakeholders about effective resource allocation processes in Uganda and possibly other LMIC.

Long-Term Effects of a Randomized Maternal Education Trial in Rural Uganda: Implications for Child Oral Health.

The aim was to examine oral health among 5-6-year-old children whose mothers participated in a 6 months' cluster-randomized education trial in rural Uganda starting when their children were 6-8 months old. The education focused on nutrition, oral hygiene, and child stimulation. In the current follow-up study, 357/511 (70%) children from the original trial were available for data collection (200 in the intervention and 157 in the control group). Molar caries was assessed on intraoral photographs. Children and/or caregivers answered a WHO health questionnaire for collection of oral data. Dental practices were compared between the intervention and control group using multilevel mixed effect logistic regression accounting for clustering. The children in the intervention group had less caries compared with the control group: 41% versus 60% (odds ratio [OR] 0.46; 95% confidence intervals [CI] 0.24-0.86, P = 0.02). The use of toothbrush to clean teeth was more frequent in the intervention than in the control group: 66% versus 38% (OR 3.39; 95% CI 1.54-7.45, P = 0.003), as was high teeth-cleaning frequency: 74% versus 62% (OR 1.72; 95% CI 1.09-2.69, P = 0.02). Self-reported problems such as toothache (10% versus 19%), difficulty biting (12% versus 24%) and chewing food (8.5% versus 18%) were significantly less frequent among children in the intervention compared with the control group. No significant differences were found in dietary habits. Our data shows that an educational intervention adjusted to a low-resource setting, provided in infancy, resulted in improved oral hygiene and reduced development of dental caries among children aged 5-6 years.