Dataset Information

Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial.

ABSTRACT: Objective/background:Guatemala's indigenous Maya population has one of the highest rates of childhood stunting in the world. The goal of this study was to examine the impact of an intensive, individualised approach to complementary feeding education for caregivers on feeding practices and growth over usual care. Design:An individually randomised (1:1 allocation ratio), parallel-group superiority trial, with blinding of study staff collecting outcome data. Setting:Rural Maya communities in Guatemala. Participants:324 children aged 6-24 months with a height-for-age Z score of less than or equal to -2.5 SD were randomised, 161 to the intervention and 163 to usual care. Interventions:Community health workers conducted home visits for 6 months, providing usual care or usual care plus individualised caregiver education. Main outcomes measures:The main outcome was change in length/height-for-age Z score. Secondary outcomes were changes in complementary feeding indicators. Results:Data were analysed for 296 subjects (intervention 145, usual care 151). There was a non-significant trend to improved growth in the intervention arm (length/height-for-age Z score change difference 0.07(95% CI -0.04 to 0.18)). The intervention led to a 22% improvement in minimum dietary diversity (RR 1.22, 95%?CI 1.11 to 1.35) and a 23% improvement in minimal acceptable diet (RR 1.23, 95%?CI 1.08 to 1.40) over usual care. Conclusions:Complementary feeding outcomes improved in the intervention arm, and a non-significant trend towards improved linear growth was observed. Community health workers in a low-resource rural environment can implement individualised caregiver complementary feeding education with significant improvements in child dietary quality over standard approaches. Clinical trial registration number:NCT02509936. Stage: Results.

SUBMITTER: Martinez B

PROVIDER: S-EPMC5926563 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial.

Martinez Boris B Webb Meghan Farley MF Gonzalez Ana A Douglas Kate K Grazioso Maria Del Pilar MDP Rohloff Peter P

BMJ paediatrics open 20180427 1

<h4>Objective/background</h4>Guatemala's indigenous Maya population has one of the highest rates of childhood stunting in the world. The goal of this study was to examine the impact of an intensive, individualised approach to complementary feeding education for caregivers on feeding practices and growth over usual care.<h4>Design</h4>An individually randomised (1:1 allocation ratio), parallel-group superiority trial, with blinding of study staff collecting outcome data.<h4>Setting</h4>Rural Maya ...[more]

PMID: 29719876

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Project description:Objective:Stunting is a common cause of early child developmental delay; Guatemala has the fourth highest rate of stunting globally. The goal of this study was to examine the impact of an intensive community health worker-led complementary feeding intervention on early child development in Guatemala. We hypothesised that the intervention would improve child development over usual care. Design:A substudy from a larger individually randomised (1:1 allocation ratio), parallel-group superiority trial, with blinding of study staff collecting outcomes data. Setting:Rural, indigenous Maya communities in Guatemala. Participants:210 stunted children (height-for-age z-score ?-2.5) aged 6-24 months, previously randomised to usual care (106) or an intensive complementary feeding intervention (104). 84 in the intervention and 91 in the usual care arm agreed to participate. Interventions:Community health workers conducted monthly home visits for 6 months, providing usual care or individualised complementary feeding education. Main outcome measures:The primary outcomes were change in z-scores for the subscales of the Bayley Scales of Infant Development (BSID), Third Edition. Results:100 individuals were included in the final analysis, 47 in the intervention and 53 in the usual care arm. No statistically significant differences in age-adjusted scores between the arms were observed for any subscale. However, improvements within-subjects in both arms were observed (median duration between measurements 189 days (IQR 182-189)). Mean change for subscales was 0.45 (95% CI 0.23 to 0.67) z-scores in the intervention, and 0.43 (95% CI 0.25 to 0.61) in the usual care arm. Conclusions:An intensive complementary feeding intervention did not significantly improve developmental outcomes more than usual care in stunted, indigenous Guatemalan children. However, both interventions had significant positive impacts on developmental outcomes. Trial registration number:NCT02509936. Stage:Results.

Project description:Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.NCT01084109.

Project description:INTRODUCTION:Incidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children's service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE. METHODS AND ANALYSIS:Families of children with autism aged 3-16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study. ETHICS AND DISSEMINATION:The current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers. TRIAL REGISTRATION NUMBER:ISCTRN83964946 (Pre-results) IRAS 213527.

Project description:BackgroundDespite numerous benefits for both mom and baby, few infants are exclusively breastfed for the recommended first six months. Additionally, infants are given solids too early. Prenatal education increases rates of breastfeeding initiation and we hypothesize it can also improve exclusive breastfeeding rates and prevent the early introduction of solids. We conducted a randomized controlled pilot and feasibility trial to understand the feasibility and maternal acceptance of a prenatal behavioral lifestyle intervention (PBLI) delivered via group based phone counseling (GBPC) and its effectiveness on rates of exclusive breastfeeding up to six months postpartum. Secondary aims included rates of any breastfeeding up to six months, rates of early introduction of solids, and infant feeding progression.MethodsForty-one pregnant women were recruited from a Kansas City Metropolitan Obstetrics and Gynecology office and randomly assigned to a usual care group or a PBLI. Women in the PBLI participated in six GBPC sessions where they learned about breastfeeding and introducing solids. Feeding questionnaires to assess breastfeeding and introduction of solids were sent at two weeks, two months, four months, and six months postpartum. Structured interviews were also conducted after the intervention and at six months postpartum to assess maternal acceptance and intervention feasibility.ResultsParticipants overwhelmingly found the intervention acceptable and beneficial. Rates of exclusive breastfeeding and any breastfeeding did not differ between groups at any time point. No between group differences were found for early introduction of solids or infant feeding progression.ConclusionsMothers discontinue breastfeeding earlier than recommended despite high rates of initiation. A PBLI delivered via GBP is feasible, acceptable to participants, and showed positive impacts such as maternal empowerment for both breastfeeding and introducing solids. Future interventions should incorporate both prenatal and postpartum components.Trial registrationStudy protocols were approved by the University of Kansas Medical Center's Human Subjects Committee (STUDY00140506) and registered at ClinicalTrials.gov on 02/22/2018 ( NCT03442517 , retrospectively registered). All participants gave written informed consent prior to data collection.

Dataset Information

Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial.

Publications

Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial.

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