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IRCT20090124001580N8 IRCT 2023-11-08 Oroumia University of Medical Sciences Effectiveness of a home-based nutritional intervention program on childhood obesity Effectiveness of a home-based nutritional intervention program on anthropometric indices of preschool children with overweight and obesity 2024-01-21 anticipated 260 Complete https://irct.ir/trial/73616 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: This study will follow cluster randomization to assign subjects to intervention and control groups. Individuals in the same clusters will receive the same intervention. There are 63 health centers and 5 urban areas in Urmia city. The randomization strata will be based on urban areas so that subjects will be the same in terms of socioeconomic level between the two groups. Considering the average number of children registered in health centers and calculating the sample size, this study will require the selection of 10 health centers. In fact, 2 health centers from each urban area will be included in the study (each group = 5 clusters). These 2 centers will be randomly selected by lottery among all health centers in that area. Then 2 clusters selected from each strata will be divided into two intervention or control groups by simple randomization method and using coins. N/A Obesity and overweight. Intervention 1: Intervention group: The trainings include 1- Basic nutritional training based on the guidelines of the Ministry of Health, 2- A nutritional pamphlet prepared for this study, 3- Providing several low-calorie nutritious food recipes to mothers, and 4- Behavioral training based on the health belief model to implement dietary changes for 6 months. Intervention 2: Control group: Routine training of health centers for 6 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Shahsanam Gheibi
Orjhans Street, Resalat Blvd
Urmia Iran (Islamic Republic of) 571478334 +98 44 3223 4897 gheibi1345sh@gmail.com Oroumia University of Medical Sciences scientific Amir Hossein Faghfouri
Orjhans Street, Resalat Blvd
Urmia Iran (Islamic Republic of) 571478334 +98 44 3223 4897 amir.nut89@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Overweight children (body mass index z-score for ages between +2 and +3) and obese children (body mass index z-score for ages above +3) 2 years 5 years Both Preschool children with a known history of systemic diseases such as heart problems, kidney problems, cancer Children or parents who are absent in more than 20% of home visits Taking medicine or nutritional supplements affecting weight in children E66 Overweight and obesity Lifestyle Lifestyle Intervention group: The trainings include 1- Basic nutritional training based on the guidelines of the Ministry of Health, 2- A nutritional pamphlet prepared for this study, 3- Providing several low-calorie nutritious food recipes to mothers, and 4- Behavioral training based on the health belief model to implement dietary changes for 6 months Control group: Routine training of health centers for 6 months Body mass index. Timepoint: Before the start of the intervention, 3 and 6 months after the start of the intervention. Method of measurement: Formula. Constructs of health belief model. Timepoint: Before the start of the intervention, 3 and 6 months after the start of the intervention. Method of measurement: Questionnaire. Percentage of subcutaneous fat. Timepoint: Before the start of the intervention, 3 and 6 months after the start of the intervention. Method of measurement: Caliper device. Waist circumference. Timepoint: Before the start of the intervention, 3 and 6 months after the start of the intervention. Method of measurement: Tape measure. Oroumia University of Medical Sciences Approved 2023-11-07 Ethics committee of Urmia University of Medical Sciences Orjhans Street, Resalat Blvd Urmia West Azarbaijan Iran (Islamic Republic of)