Background: Childhood obesity is a public health issue negatively affecting children’s physical and psychosocial health. Mothers are children’s primary caregivers, thus key players in childhood obesity prevention. Studies have indicated that mothers underestimate their children’s weight. If mothers are unaware of their children’s weight problem, they are less likely to participate in activities preventing and treating excess weight. The “Healthy Change” intervention is designed to change maternal perception of child’s weight (MPCW) through peer-led group health education in childcare settings. Methods/Design: The “Healthy Change” is a multicenter two-arm randomized trial in four centers. Three centers are in Mexican States (Nuevo Leon, Tamaulipas, and Zacatecas). The fourth center is in San Antonio, Texas, USA. A total of 360 mother-child pairs (90 pairs per center) are to be randomly and evenly allocated to either the intervention or the control group. Intervention group will receive four-session group obesity prevention education. Control group will receive a four-session personal and food hygiene education. The education is delivered by trained peer-mother promotoras. Data will be collected using questionnaires and focus groups. The primary outcome is a change in proportion of mothers with accurate MPCW. Secondary outcomes include change in maternal feeding styles and practices, maternal self- efficacy and actions for managing child excessive weight gain. McNemar’s Test will be used to test the primary outcome. The GLM Univariate procedure will be used to determine intervention effects on secondary outcomes. The models will include the secondary outcome measures as the dependent variables, treatment condition (intervention/control) as the fixed factor, and confounding factors (e.g., mother’s education, children’s gender and age) as covariates. Sub-analyses will be performed to compare intervention effects on primary and secondary outcomes between the samples from Mexico and Texas, USA. Qualitative data will be analyzed through analysis of inductive content. A combined coding model will be developed and used to code transcripts using the NVivo software. Discussion: Healthy Change intervention could help change MPCW, an initial step for obesity prevention among preschoolers. This study presents a first of its kind intervention available in Spanish and English targeting Mexican and Mexican-American mothers in Mexico and USA. Trial registration: ISRCTN12281648 Keywords: Multicenter study, Health behavior, Maternal perception, Body weight, Pediatric obesity, Mother-child relations, Parenting * Correspondence: firstname.lastname@example.org Autonomous University of Nuevo Leon (UANL), College of Nursing, Av. Gonzalitos No. 1500 Norte, Col. Mitras Centro, C.P. 64460 Monterrey, Nuevo León, Mexico Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Flores-Peña et al. BMC Public Health (2018) 18:669 Page 2 of 7 Background participants in the intervention programs. As such, the Childhood obesity is a worldwide epidemic that dispro- “Healthy Change” intervention is designed to change ma- portionally affects certain racial/ethnic groups . Mexico ternal misperception of her child’s weight (MPCW) is among the countries with the highest prevalence of through peer-led parental education in childcare settings. childhood obesity [2, 3]. Obesity is more prevalent in Mexican-American children than their white counterparts Methods in the United States of America (USA) . Childhood Aims obesity has been found to increase health risks, e.g. hyper- This pilot study aims to develop and test the effects of lipidemia, hypertension and abnormal tolerance to glu- the “Healthy Change” intervention on changing maternal cose. In addition, it has been documented that overweight perception of preschoolers’ weight status among Mexican (OW) preschoolers were four times more likely to become mothers in México, and Hispanic mothers in San Antonio, obese (OB) adolescents than their normal weight coun- Texas. Specific objectives are 1) To test the feasibility of terparts . Given the consequences of overweight and “Healthy Change” intervention when implemented in a obesity on physical and psychosocial health, as well as childcare setting; 2) To assess the effect of “Healthy the heavy economic burden on health care, Public Health Change” intervention on changing maternal perception interventions are urgently needed to fight this epidemic in of their preschoolers’ weight status; and 3) To assess both USA and Mexico . the effect of the “Healthy Change” intervention on chan- Obesity is a multi-faced etiological disease with risk fac- ging parenting style, maternal attitude, self-efficacy and tors such as genetic predisposition , increased energy practice toward raising healthy weight children. consumption, sedentary lifestyle, poor socio-economic status, as well sociocultural factors and false beliefs about Trial design childhood obesity [7, 8]. Unlike adults, children cannot The “Healthy Change” study is a multicenter two-arm choose the environment in which they live or the food randomized trial with four research sites, three in Mexico: they eat . Mothers are influential in shaping life habits a) Nuevo León, b) Tamaulipas, and c) Zacatecas, and one of young children, thus important agents for childhood in San Antonio, Texas, USA. At each site, two childcare obesity prevention [10, 11]. However, research has shown centers are randomly assigned to either the intervention that mothers of young children, do not perceive over- or the attention control group. A total of 360 pairs of weight or obesity as a health threat. Instead, they prefer preschoolers and their mothers, i.e., 90 pairs per site, chubby children [12, 13]. In Mexico, a study on mothers are recruited for the trial. Intervention participants will and children residing in 5 northeastern states found that receive a four-weekly group education focusing on ma- 68% of mothers of overweight children and 75% of ternal perception of children’s bodyweight that facilitate mothers of obese children underestimated their pre- healthy behavioral changes for the family. Control par- schoolers’ body weight . In addition, Mexican and His- ticipants will receive a four-session group education on panic mothers exert control and discipline that could lead food hygiene and first aids as attention control. The to over consumption of foods and increased obesity risk outcomes include change in the proportion of mothers [15, 16]. More problematic, when mothers were not aware who accurately estimate their children’s weight categor- of their children’s overweight status, they had a lower self- ies, change in feeding style, maternal self-efficacy and efficacy to manage behaviors related to their child’s weight actions taken in managing the child’s excessive weight in comparison to mothers of normal weight children gain. Data are to be collected at baseline and the end of [17, 18]. Such research findings highlight the need for cor- the four-week group education from both groups. The recting mothers’ misperception of their children’sover- study began on 08–29-2015, and will end on 11–20-2018. weight status as the first step for obesity [8, 19, 20]. Childhood obesity prevention programs should incorp- Study setting orate strategies targeting mothers’ misperception of their The study will be conducted in childcare settings, i.e., children’s weight status. A study conducted in Iran doc- kindergarten classes in Mexico and Head Start Centers umented the impact of an educational intervention on in Texas, USA. maternal perception of school children’s weight. The study showed a significant increase in the capacity of Sample size and statistical power mothers to recognize their children’s obese weight status The primary outcome of this intervention will be the pro- . Interventions to prevent and treat OB in preschool portion of mothers who adequately estimate their child’s Mexicans are scarce and have been directed to diet and weight status. Assuming the intra-class correlation coeffi- exercise, showing little effect or none . Also in these cient (ICC) of 0.03, to detect a change of mother’saccur- interventions, maternal perception of children’s weight has ate estimation of children’s weight status from 50 to 70% not been evaluated (MPCW) prior to incorporate with 80% power, 37 mother-child pairs would be required Flores-Peña et al. BMC Public Health (2018) 18:669 Page 3 of 7 per research center per arm . Accounting for a 15% Intervention attrition rate, each research site will enroll 45 pairs of The intervention “Healthy Change” is informed by the mothers and children for the intervention and another Social Cognitive Theory (SCT) . SCT describes human 45 pairs for the control group. The total sample size for behavior as a dynamic and reciprocal interaction of per- this four-center trial will be 360 pairs of mothers and sonal factors, behavior, and the environment . Based children. on the SCT, Healthy Change intervention strategies focus on cognitive and behavioral skills to enable mothers to Childcare center recruitment and randomization take actions in managing their child’s weight. The appli- Each research site will recruit a total of 90 pairs of pre- cation of Social Cognitive Theory Concepts is shown in schoolers and their mothers with 45 pairs in the interven- Table 1. The Healthy Change intervention curriculum tion and 45 pairs in the control group. Each research site consists of four sessions: 1) Understanding excess initially recruits two childcare institutions with similar size weight and obesity as a health problem and current and and demographic profiles to participate in the study. The future health consequences; 2) How is my child’s weight?; administrators of these centers are informed of the possi- 3) Maternal feeding styles and physical activity; and 4) I bility of being assigned to either the intervention or the can!, which includes strategies to management child’s control group. Prior to participant recruitment, the two health behaviors. or three childcare institutions at each research center Attention control is considered a valid control condition are randomly assigned to one of the two treatment groups when conducting trials of social-behavioral interventions using a random number table. In the event that an insuffi- such as Healthy Change. We developed an attention con- cient sample is recruited from the participating centers, a trol curriculum with a similar dose of group education en- third center will be added to ensure adequate sample in titled: “Hygiene and Health Promotion”. The four weekly the designated group. group sessions cover the following topics: 1) The mother as her child’s hygiene promoter; 2) Hygiene and food Participant inclusion and exclusion criteria safety at home; 3) Best ways to store food in your kitchen; Mothers of Mexican descent, along with their preschoolers and 4) Accident prevention at home and surrounding between the age of 3 and 5 years old enrolled in par- areas. ticipating childcare centers are eligible for the study. Each session for both groups will last about 90 min Preschoolers. and will be held in a room within the participants’ own childcare institution. Both the Healthy Change and Hy- Participant recruitment giene and Health Promotion curriculum are available in Participants will be recruited through meetings, flyers, two languages, Spanish and English. In Mexico, the and take-home letters. Interested parents will be screened content is delivered in Spanish. In the USA, mothers for study eligibility and informed consent will be obtained select the language of their preference for group prior to data collection. education. Table 1 Social Cognitive Theory (SCT) Concepts and Components of “Healthy Change” Intervention Group Concepts of SCT Intervention strategies Reciprocal determinism: explore personal and environmental factors -Investigate the maternal beliefs related to OW-OB that can contribute to the change of cognition and behavior. -Etiology of obesity: genetic factors and environmental -Present and future health effects of OW-OB -Recognize signs indicating that a child is OW-OB -Image perceived vs actual image Self – efficacy: Increase Self-efficacy to manage child’s life style - Explore achievements that have been reached in management child’s behaviors related to weight. life style behaviors related to weight and techniques which could be Modeling - learning by observation generalized as desired behaviors. - Ask the mother to comment an attempt which failed and explore individual and environmental factors that might have contributed in this attempt failed. - Teaching strategies of calm moment and time out. - Ask the mother that practice strategies and provide feedback Behavioral capacity: providing opportunities for the mother to master - Together, identify actions that can be performed to manage child’s life necessary skills style behaviors related to weight. Reinforcement: Increase the expectations of outcomes’ behavior - Together, identify maternal feeding style and feeding practices of the Reinforcing positive behaviors. participating mothers. - To identify factors of which contribute to the increase of child’s weight. - Teaching the participating mother practices that contributes to a healthy child’s weight. Flores-Peña et al. BMC Public Health (2018) 18:669 Page 4 of 7 Procedure to implement the intervention underweight”, “aboutthe rightweight”, “a little over- The Healthy Change study uses a train-the-trainer model weight”,or “overweight” (MPCW by words). Mothers for intervention delivery. Each research site director is also checked one of the body sketches (MPCW by image) responsible for identifying and recruiting Promotoras in the age range 2 to 5 years old [19, 26]. from the participating childcare centers. To qualify, a Secondary outcomes include: Promotora must have a child enrolled at the participat- ing childcare center. Promotora training includes 6 h of a) Change in the maternal feeding styles. Maternal face-to-face training on the overall study, each session’s feeding styles is measured using the Caregiver content, take home activities, and interpersonal com- Feeding Style Questionnaire. The questionnaire munication skills. Promotoras take and must pass a cer- consists of 19 questions grouped in two dimensions: tification exam in order to qualify for delivering the demandingness and responsiveness. Subsequent parent sessions. If she does not pass the exam, she will calculation of the median of both dimensions places receive remediation and will be asked to retake the participants in one of the four styles, i.e., authoritative, exam. Promotoras who do not pass the exam on the authoritarian, indulgent, or uninvolved . second attempt will not qualify to serve as Promotoras b) Increased self-efficacy score of maternal influencing for the study. on children’s health behavior. Mothers rate their The intervention includes Promotora-led sessions held confidence on a 5-point Likert scale ranging from in the classroom. Promotoras will use an English or “strongly disagree” to “strongly agree” on these two Spanish facilitator guide to deliver the content. Promo- statements: “I can influence my child’s food choices” toras have access to a projector and screen, whiteboard and “I can influence my child’samount physical and markers or chalk, pencils, sheets and participant activity” . rosters. c) Improved score of family nutrition and physical activity. The Family and Nutrition and Physical Evaluation methods Activity (FNPA) screening tool is used to assess Process evaluation mothers’ practices that may predispose children to Process evaluation of the intervention will include mul- becoming overweight . The FNPA tool consists tiple data sources including, but not limited to, session of 20 questions assessing family meals, family eating duration, attendance, and context. Research personnel practice, food and beverage choices, material will observe a random group education session to assess feeding restriction/ reward practice, child’s screen delivery using a Healthy Change Fidelity Checklist. Focus and activity time, sleep schedule, family activity groups will be conducted with up to 12 participating routine and healthy environment . Each mothers in the intervention group at each research site at question has four options: i.e., “Never/Almost the end of the intervention. Program participants will be Never”, “Sometimes”, “Often”, and “Very Often/ invited to participate in these group discussions on the Always” . day of the endpoint questionnaire. At least one focus d) Reduction or maintenance of the child’s BMI and group will be held at each participating center. An exter- BFP: The child’s weight is measured by Seca Scale nal experienced moderator along with a co-facilitator will 813 and height by Seca stadiometer 214, the BFP is use a semi-structured interview guide to facilitate each measured by bioelectrical impedance by InBody 230. focus group. All focus group meetings will be audio- recorded and transcribed verbatim. The recordings will be Maternal BMI is assessed as a medicating factor. The transcribed and imported into NVIVO software for maternal weight is measured using Seca scale 813 and analysis . the height with stadiometer SECA 214. Subsequently, the maternal BMI is calculated and classified as: low Outcome evaluation weight (< 18.5), normal weight (18.5–24.9), pre-OB (25.0 Baseline and post-intervention data will be collected on to 29.9), OB I (30.0–34.9), OB II (35.0–39.9) and OB all participants. Each mother will receive 25 USD at the III (> 40) . Maternal body fat percentage (BFP) end of the intervention for their participation in the data will be measured by bioelectrical impedance by collection. The primary outcome of this study is the InBody 230. proportion of mothers who accurately estimate their A self-administered questionnaire is used to collect children’s weight status. Maternal perception of child’s socio-demographic data, e.g., age, education level, marital weight is measured using the Parents’ Perceptions about status, monthly family income and child’s age and sex, as Their Child’s Appearance and Health Questionnaire . well as degree of acculturation using the Scale of Ac- Mothers are asked to indicate their child’sweight sta- culturation of the Hispanic for participants in Texas, tus from 5 response options: “underweight”, “alittle USA . Flores-Peña et al. BMC Public Health (2018) 18:669 Page 5 of 7 Data analysis Ethics and dissemination Healthy change intervention feasibility This project has been reviewed, approved and registered Researchers will analyze qualitative data from the focus by Ethical Research Committee of College of Nursing of groups using inductive content analysis . A team ap- the Autonomous University of Nuevo León (FAEN-P-1144) proach will be utilized to analyze data with a minimum and for The University of Texas at San Antonio, Institu- of three researchers independently reviewing each tran- tional Review Board (16-203 N). Written informed consent script and identifying emerging themes. The team will to participate in the study was obtained from participants, then convene to discuss, compare, and merge themes to and the mothers’ consent for the participation of their develop a coding template. NVivo software will be used children. to assist in data organization. All data will be stored in a secured place with access limited to research staff only. All hard copy files will be Healthy change intervention effect stored in locked filing cabinets within the laboratory and The quantitative data will be analyzed in Statistical Pack- all electronic files will be stored on password-protected age for the Social Sciences (SPSS) version 23. WHO computers. Only the research staff will have access to Anthro (version 3.2.2, January 2011) and macros will be files and the link connecting names to the issued identity used to calculate children’s age- and gender- specific BMI codes. All laboratory staff will undergo rigorous training percentile and children will be classified by the World on data collection, data entry, and data storage proce- Health Organization | BMI-for-age chart: malnutrition dures to ensure all participant information is protected. (percentile < 3), low weight (≥3 and < 15), normal weight Research records will not be released without a partici- (≥15 and < 85), OW (≥85 but < 97), and OB (≥97) . pant consent unless required by law or a court order. The The rate at which mothers accurately classify their chil- data from participants may be used in publish and/or dren’s weight status will be calculated in two ways, i.e., presentations, but participants’ identities will not be by words or by images. Accurate MPCW by words will disclosed. The information discussed in focus groups, be defined as show in Table 2. will be audiotaped, and transcribed by a trained re- With regard to the MPCW by image test, an accurate search staff for the analysis. All storage of data will take perception is defined when mothers of underweight and place on password-protected computers that only re- normal weight children select an image smaller than the search staff have access. No information to identify in- average image or when mothers of children with dividuals or any institution will be reported. Participant OW-OB select the average or a larger image. identity, comments, as well as all audiotapes and written McNemar’s Test will be used to test the primary records will be kept confidential and secure. All data col- outcome measure, i.e., intervention effect on change lected from these focus groups will have names removed in proportion of mother’s accurate recognition of their upon collection, such that names will not be used at any preschooler’s weight status. The GLM Univariate pro- time during the research process, or the dissemination cedure will be used to determine intervention effects findings. Following completion of the analysis, all tape on secondary outcomes e.g., scores of mother’s self-efficacy, recordings will be deleted. Research findings will be feeding practices and children’s BMI percentiles and fat%. published in peer-reviewed journals and communicated The models will include the secondary outcome measures to key audiences, including personnel of participants’ as the dependent variables, treatment condition (interven- childcare centers. tion versus control) as the fixed factor, and confounding factors (e.g., mother’s education level, children’sgender and age) as covariates. Sub-analyses will be performed to Discussion compare intervention effects on both primary and sec- Childhood OB is one of the most serious public health ondary outcomes between the samples from Mexico and issues of the twenty-first century. Children with OB are Texas, USA. at increased risk of obesity as adults and are more likely to develop chronic health conditions, such as diabetes and cardiovascular disease, at a younger age. It is therefore Table 2 Accurate MPCW by words necessary to implement strategies from childhood to pre- Children’s actual weight status by BMI MPCW by words vent and treat OW-OB paying special attention to parents, percentile given that they not only act as behavior moderators, but Malnutrition (< 3 percentile) Low weight “underweight” or “a little also are responsible for the quality and quantity of food (≥ 3 and < 15 percentile) underweight” made available to their children. When parents are in- Normal weight (≥ 15 and < 85 percentile), “Normal weight” volved in interventions to prevent and treat weight Overweight (≥ 85 but < 97 percentile) “A little overweight” problems in their children, there are more possibilities Obese (≥ 97) “Overweight” of achieving satisfactory outcomes. Flores-Peña et al. BMC Public Health (2018) 18:669 Page 6 of 7 The pilot study aims at correcting Mexican mothers’ Competing interests The author(s) declare(s) that they have no competing interests. misperception of their children’sweight statusasthe initial step of obesity prevention. Studies conducted in Publisher’sNote countries such as the USA, Italy, United Kingdom, Springer Nature remains neutral with regard to jurisdictional claims in Germany and Malaysia have assessed MPCW and found published maps and institutional affiliations. that the majority of mothers of children with OW-OB Author details have misperceptions of their child’s weight, and they Autonomous University of Nuevo Leon (UANL), College of Nursing, Av. underestimate it; this misperception could have impact Gonzalitos No. 1500 Norte, Col. Mitras Centro, C.P. 64460 Monterrey, Nuevo in other parenting strategies related to feeding and León, Mexico. The University of Texas at San Antonio, College of Education and Human Development, San Antonio 78249, Texas, USA. Autonomous physical activity of their child. On the other hand, only University of Tamaulipas (UAT), College of Multidisciplinary Knowledge, Av, one study conducted in Iran documented the impact of del Maestro y Marte S/N, H. Matamoros 87410, Tamaulipas, Mexico. an educational intervention on maternal perception of University of Zacatecas, Academic Unit of Nursing, Carretera Zacatecas - Guadalajara, Km. 6, Ejido la Escondida, Zacatecas 98160, Zacatecas, Mexico. her child’s OB in scholar age; therefore, we conduct this research to evaluate the feasibility and effect of “Healthy Received: 16 October 2017 Accepted: 3 May 2018 Change” intervention on MPCW of her pre-school child, through accuracy MPCW post intervention. References This collaborative research endeavor can produce prom- 1. Swinburn B, Sacks G, Hall K, McPherson K, Finegood D, Moodie M, et al. 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