Study Protocol for a Controlled Trial of Nutrition Education Intervention about Celiac Disease in Primary School: ZELIAKIDE Project.
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SUBMITTER: Vazquez-Polo M
PROVIDER: S-EPMC10857138 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Study Protocol for a Controlled Trial of Nutrition Education Intervention about Celiac Disease in Primary School: ZELIAKIDE Project.
Vázquez-Polo Maialen M Churruca Itziar I Perez-Junkera Gesala G Larretxi Idoia I Lasa Arrate A Esparta Jon J Cantero-Ruiz de Eguino Leire L Navarro Virginia V
Nutrients 20240123 3
The only treatment for celiac disease (CD) is a strict and lifelong gluten-free diet (GFD), which must be safe and nutritionally balanced. Avoiding gluten brings difficulties with following the diet and can affect the social life of people with CD. The Zeliakide Project is a nutrition education program aimed at increasing the knowledge of the general population about healthy diets, CD and GFD, and, therefore, to improve the social inclusion and quality of life of people with CD. It is a one-mont ...[more]
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Project description:IntroductionSchools are an important setting for supporting children's development of food literacy, but minimal research has assessed which strategies are most suitable for school nutrition education. The Foodbot Factory intervention, consisting of serious game (ie, a digital game designed for education) and curriculum-based lesson plans, was developed to support teachers and children ages 8-12 with nutrition education. Pilot data have demonstrated that Foodbot Factory can significantly improve children's nutrition knowledge, but it has not yet been evaluated in classrooms.Methods and analysisA single-blinded cluster randomised controlled trial was designed in 2022 by a research team based at Ontario Tech University to determine the efficacy of the Foodbot Factory intervention in improving children's nutrition knowledge, attitudes and behaviours. 32 grade 4 and 4/5 classrooms in Ontario will be randomised to receive (1) the Foodbot Factory intervention or (2) a control nutrition education intervention using conventional materials (eg, activity sheets). The study's primary outcome is to determine the overall nutrition knowledge acquired from the intervention. Secondary outcomes include nutrition knowledge subscores (ie, knowledge of specific food groups), nutrition attitudes, dietary intake, general nutrition behaviours (eg, eating breakfast) and intervention acceptability. An Ontario-certified teacher will deliver the intervention to both groups for 35-40 min/day for five consecutive days. Outcomes will be assessed at baseline, immediately postintervention, and 4 weeks and 3 months postintervention using the Nutrition Attitudes and Knowledge questionnaire, the Block Kids Food Screener, a modified Family Nutrition and Physical Activity screener and an acceptability questionnaire. Generalised linear mixed models will assess changes in outcomes between groups.Ethics and disseminationThe study protocol is approved by research ethics boards at Ontario Tech University and participating school boards. Results of the trial will be published in peer-reviewed journals and lay summaries will be available to stakeholders.Trial registration numberNCT05979259.
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Project description:IntroductionSecondary schools have the transformative potential to advance adolescent nutrition and provide a unique entry point for nutrition interventions to reach adolescents and their families and communities. Integrated school nutrition interventions offer promising pathways towards improving adolescent nutrition status, food security and building sustainable skill sets.Methods and analysisThe Meals, Education, and Gardens for In-School Adolescents (MEGA) project aims to implement and evaluate an integrated, school-based nutrition intervention package among secondary schools in the Chamwino District of Dodoma, Tanzania. MEGA is a cluster-randomised controlled trial, including six public secondary schools assigned to three different arms. Two schools will receive the full intervention package, including school meals, school gardens, nutrition education and community workshops. Two schools will receive the partial intervention package, including the school garden, nutrition education and community workshops. Two schools will serve as the controls and will not receive any intervention. The intervention will be implemented for one academic year. Baseline and end-line quantitative data collection will include 750 adolescents and 750 parents. The domains of outcomes for adolescents will include haemoglobin concentrations, anthropometry, educational outcomes and knowledge, attitudes and practices regarding nutrition, agriculture and health. The domains of outcomes for parents will include knowledge, attitudes and practices of nutrition, agriculture and health. End-line focus group discussions will be conducted among selected adolescents, parents and teachers to assess the facilitators and barriers associated with the intervention.Ethics and disseminationThis study was approved by the Institutional Review Board at Harvard T.H. Chan School of Public Health (approval number: IRB20-1623), the Institutional Research Review Committee at the University of Dodoma (approval number: MA.84/261/02) and the Tanzania National Institute for Medical Research (approval number: NIMR/HO/R.8a/Vol. IX/3801). A manuscript with the research findings will be developed for publication. Local dissemination meetings will be held with key stakeholders.Trial registration numberNCT04788303.; ClinicalTrials.gov Identifier.
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Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.
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Project description:ObjectiveTo measure the efficacy of school-based nutrition education on dietary diversity of the adolescent girls in Bangladesh.MethodsA matched, pair-cluster randomized controlled trial was conducted from July 2019 to September 2020. Randomization was done to select intervention and control schools. There were 300 participants (150 in the intervention and 150 in the control arm) at baseline. We randomly selected our study participants (adolescent girls) from grades six, seven, and eight of each school. Our intervention components included parents' meetings, eight nutrition education sessions, and the distribution of information, education, and communication materials. An hour-long nutrition education session was provided using audio-visual techniques in a class of intervention school once a week by trained staffs of icddr,b for two months. Data on dietary diversity, anthropometry, socio-economic and morbidity status, a complete menstrual history, and haemoglobin status of adolescent girls were collected at recruitment and after five months of intervention. We calculated the mean dietary diversity score of adolescent girls at baseline and at the endline. As the dietary diversity score was incomparable between the control and intervention arm at baseline, we performed the difference-in-difference analysis to assess the effect of the intervention.ResultsMean age of the adolescent girls was 12.31 years and 12.49 years in the control and intervention arms respectively. Percentages of consumption of organ meat, vitamin A-rich fruits and vegetables, legumes, nuts, and seeds were higher in the intervention arm than in the control arm at the end-line. The mean dietary diversity score remained unchanged in the control arm at 5.55 (95% CI: 5.34-5.76) at baseline and 5.32 (95% CI: 5.11-5.54) at the endline. After the intervention, mean dietary diversity increased from 4.89 (95% CI: 4.67-5.10) at baseline to this mean was 5.66 (95% CI: 5.43-5.88) at the endline. Result from the difference-in-difference analysis revealed that the mean dietary diversity was likely to increase by 1 unit due to intervention.ConclusionThe shorter duration of the intervention in our study could not show whether it could change the behavior of adolescent girls in increasing dietary diversity through school-based nutrition education, but it showed a pathway for increasing dietary diversity at school. We recommend including more clusters and other food environment elements in retesting to increase precision and acceptability.Trial registrationThis study was registered with ClinicalTrials.gov, trial registration no: NCT04116593. https://clinicaltrials.gov/ct2/show/NCT04116593.
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