Letter of Intent (Loi): Addressing Disparities Template

LETTER OF INTENT (LOI): ADDRESSING DISPARITIES TEMPLATE

TITLE OF PROPOSED STUDY: Reducing Disparities in Childhood Obesity via a Parent Mentor Partnership

1. Specific Aims: State the specific aims of this study.

Parents of obese or overweight children frequently underestimate their child’s weight, normalizing it or sometimes preferring a heavier child, and these tendencies aremore common in the Hispanic population.1–4 Without recognition of the child’s weight as a problem, parents are unlikely to engage in behavior change or to seek help from their primary care providerto address the health issue.

1. Determine whether a parent mentor intervention versus an educational intervention improves the accuracy of weight perceptions in parents of overweight and obese children.

2. Evaluate the role that perception of weight plays in a) behavioral change around weight-related behaviors and b) accessing primary care as a resource for achieving a healthy weight

3. Measure the effect of a parent mentor intervention on obese and overweight children’s BMI z-score over 1 year

2.Condition Burden and Impact: Briefly state the importance of the condition or problem in terms of prevalence and/or impact.

Over 30% of all children in the United States are overweight or obese and about 25% of 2-5 year olds. In south Texas, with an 80% Hispanic population and 32% poverty, the prevalence is even higher with 40% of pre-school age children being overweight or obese. Early childhood weight status tracks through adolescence and adulthood.

3. Gap Analysis: Add a statement describing the evidence gap;be sure to includereferences, such as systematic review(s), guidelines, and other evidence.

There are very few evidence-based treatment interventions for overweight or obese 2-5 year olds; systematic reviews have identified this as a major evidence gap,5–7 particularly in the Hispanic population where the burden of obesity is greater,8 but the evidence even more lacking.9,10 To address this gap, the NIH has released two recent requests for applications to evaluate interventions in this age group.

Research shows that Hispanic parents of overweight children do not perceive their children as overweight nor do they see overweight as a health issue. A systematic review of studies among Hispanic parents found that almost half of Hispanic parents of obese children did not perceive their child as obese and in two studies, most Hispanic parents preferred moderately overweight children.11 The reviewed studies also showed that parents had limited understanding of the short-term consequences associated with childhood obesity. These issues can impede the impacts of treatment interventions for this high-risk group. Research on treatment interventions that address these misperceptions is extremely limited but could lead to greater impacts on childhood obesity treatment among Hispanic families. Educational models have been used in early childhood education without success in Hispanics10, and parent mentoring is widely used in early childhood education without an assessment of its impact on weight perception.12

4. Study Design: Please provide a concise description of the study design including theoretical or conceptual framework and how it informs the design and variables being tested. Indicate whether the main (CER) question understudy is to be addressed as a randomized trial (individual level or cluster), observational study (retrospective, prospective), quasi-experimental study, or other (please specify).

This is a cluster, randomized trial assigning parents of overweight and obese children to receive either a parent mentorora standard educational intervention across two Head Start organizations in both a rural and an urban location. Individual Head Start centers with each organization will be randomized to either use educational materials or a parent mentoring model; currently both options have been used in early childhood settings to address obesity withoutany studies comparing their effectiveness. We will assess socioeconomic factors in order to address potential confounding at the center level given the cluster randomization.

5. Description of Participants and Participating Study Site(s):Describe the relevant demographic characteristics of the participants who are the target of the intervention, includinghow well they represent the target population, source of participants, and inclusion and exclusion criteria. Where the unit of randomization is a study site, rather than the participant, please describe representativeness of proposed participating sites.Please specify which of the target population(s)[e.g., racial/ethnic minorities, low-income individuals, rural, individuals with limited English proficiency, LGBT, individuals with disabilities] your proposed research will address.

The lower Rio Grande Valley Head Start organization (NINOS) has 41 sites across two counties. The San Antonio Head Start organization (FSA) has 29 sites. We will recruit from within the 70 sites for site coordinators interested in participating; we have previously found high levels of engagement with nearly all sites interested in participating. The participating sites have from 20-40 children age 2-5 years of age enrolled with the vast majority of parents of the children being Hispanic with limited English proficiency and have incomes below the federal poverty line. Approximately 40% of these children are overweight or obese based on local Head Start data.

Inclusion and exclusion criteria will be applied to individual children at each site. Inclusion criteria are being overweight or obese for age and sex defined as >85th percentile BMI. Exclusion criteria are significant developmental delay, genetic syndromes known to influence weight and taking medication known to influence weight.

6. Outcomes: Describe the study outcomes, the key constructs to be measured, the validated measures to assess key constructs, and why the outcomes are important to patients.

One of the key outcomes identified by the parent stakeholders is weight perception, i.e. do the parents perceive their child to be at a healthy weight or not. We will use a standardized pictographic representation of children at different weights from thin to obese along with qualitative interviews among a subset of parents assessing health perception and weight perception. The primary outcome used to determine power will be body mass index (BMI); secondary outcomes will include a standardized assessment of feeding behaviors and practices13and the Pediatric Quality of Life scale. We will ask parents to self-report on their interaction with their primary care provider in terms of the discussion and plan to address their child’s weight with a subset chart review to assess validity.

7. Power Calculations: State the power of the proposed study to detect the hypothesized effect, including support for all assumptions, (e.g., type-1 error level, standard deviation in outcome measure, underlying event rate). Note power for important subgroups, if applicable.

Children in the 2-5 year old age group who are obese should have a goal of weight maintenance which, with normal expected growth in height, should lead to a reduction of 10% in BMI over 1 year, or 2 BMI points. Using the assumptions of a 40% overweight and obesity prevalence in each center giving a cluster size of 20, a type-1 error level of 0.05, a conservative estimate of theintra-classcorrelation coefficient at 0.1,14 and a standard deviation of 1.5 for BMI, we would need 27 centers in each arm to achieve 80% power. The centers would be stratified by region.

8. Hypothesized Effect Size for Intervention on Main Patient-Centered Outcome: State the hypothesized effect size and cite references to support that the effect size is both realistic and clinically meaningful.

A recent review showed that over 80% of parents of overweight and obese children age 2-6 years old misperceive their child’s weight as normal.15 There are limited data on weight perception post-intervention. Based on the limited data, we expect to see a reduction from 80% to 60% in the parent mentor group.16,17We expect to see a difference in BMI of 10% with a target of weight maintenance in the parent mentor group. Prior studies have demonstrated weight maintenance as a realistic goal for interventions in this age group.18,19

1. Sample Size:Provide the total sample size for the main CER analysis and the number per arm (N1, 2, 3, 4 . . .), as applicable.

N (total) = 54 centers representing 1080 children

N1= 27 centers representing 540 children

N2= 27 centers representing 540 children

10. Comparators:List the options being compared. Note that all options should be in current use.

1. Education provided to parents on early childhood obesity and healthy habits in childhood

2. Parents mentoring other parents to encourage accurate weight perception and healthy habit goal setting.

11. Description of Comparators:Describe each option listed above under “Comparators,”including:

a)Evidence of the efficacy or effectiveness of each or statements about its acceptance in practice despite having limited evidence of efficacy or effectiveness

b)An estimate of frequency of use in clinical practice

c)If usual care is a comparator, justification of itsinclusion and a proposal to clearly describe its components

Health education in Head Start centers is usual care and mandated by the federal grants, which fund these centers. The evidence for the effectiveness of this education on reducing overweight or obesity in early childhood is limited with general participation in Head Start having been found to have an effect on weight,20 and educational programs to promote a healthy weight having some evidence of efficacy.10,21,22Parent mentors are also widely used in Head Start centers12 but there are limited data on whether they may reduce overweight or improve perceptions of weight.

12.Engagement:Briefly state how patients and stakeholders are involved in all aspects of the research and list specific organizations involved.

The parental leadership of Head Start has contributed via focus groups and direct input by focusing on weight perception as the primary barrier to addressing behavioral change around weight status in this population. The Head Start centers’ staff and parental leadership will be involved in the design of the parent mentor intervention and in choosing the comparator educational curriculum to implement across the centers.

13.Duration of Study:State duration of intervention and length of follow-up as they fit in to a 3-year project.

The two interventions being compared will be implemented over the normal course of a Head Start year, starting in August and ending in June of the next calendar year. We will conduct an interval assessment after the first year using the initial data, feedback from stakeholders and parents and integrate that into the 2nd year implementation. The 3rd year will be used to translate the findings for other Head Start centers and develop a model for wider dissemination.

14.“Real-Life” Applicability of Strategies: State how the intervention will be delivered and received in real-life clinical settings and will provide practical information that can help patients and other stakeholders make informed decisions about their health care and health outcomes.

These two strategies to improve weight perceptions will be delivered in the context of ongoing, usual care early childhood education centers and the assessment of accessing care in community pediatric settings. These strategies will be targeted towards improving the decisions that parents make about accessing the resources offered by their primary care physicians for early childhood obesity. We will assess the degree to which they make these decisions and the effect on the health outcome of the weight of their child.

References:

1. Carnell S, Edwards C, Croker H, Boniface D, Wardle J. Parental perceptions of overweight in 3-5 y olds. Int J Obes (Lond). 2005;29(4):353-355. doi:10.1038/sj.ijo.0802889.

2. Chaparro MP, Langellier BA, Kim LP, Whaley SE. Predictors of accurate maternal perception of their preschool child’s weight status among Hispanic WIC participants. Obesity (Silver Spring). 2011;19(10):2026-2030. doi:10.1038/oby.2011.105.

3. Hudson E, McGloin A, McConnon A. Parental weight (mis)perceptions: factors influencing parents’ ability to correctly categorise their child's weight status. Matern Child Health J. 2012;16(9):1801-1809. doi:10.1007/s10995-011-0927-1.

4. Intagliata V, Ip EH, Gesell SB, Barkin SL. Accuracy of self- and parental perception of overweight among Latino preadolescents. N C Med J. 69(2):88-91. Accessed August 29, 2014.

5. Hoelscher DM, Kirk S, Ritchie L, Cunningham-Sabo L. Position of the Academy of Nutrition and Dietetics: interventions for the prevention and treatment of pediatric overweight and obesity. J Acad Nutr Diet. 2013;113(10):1375-1394. doi:10.1016/j.jand.2013.08.004.

6. Showell NN, Fawole O, Segal J, et al. A systematic review of home-based childhood obesity prevention studies. Pediatrics. 2013;132:e193-e200. doi:10.1542/peds.2013-0786.

7. Ho M, Garnett SP, Baur L, et al. Effectiveness of lifestyle interventions in child obesity: systematic review with meta-analysis. Pediatrics. 2012;130(6):e1647-e1671. doi:10.1542/peds.2012-1176.

8. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311:806-814. doi:10.1001/jama.2014.732.

9. Pérez-Morales ME, Bacardí-Gascón M, Jiménez-Cruz A. Childhood overweight and obesity prevention interventions among Hispanic children in the United States: systematic review. Nutr Hosp. 27(5):1415-1421. doi:10.3305/nh.2012.27.5.5973.

10. Fitzgibbon ML, Stolley MR, Schiffer L, Van Horn L, KauferChristoffel K, Dyer A. Hip-Hop to Health Jr. for Latino preschool children. Obesity (Silver Spring). 2006;14:1616-1625. doi:10.1038/oby.2006.186.

11. Sosa ET. Mexican American mothers’ perceptions of childhood obesity: a theory-guided systematic literature review. Health Educ Behav. 2012;39(4):396-404. doi:10.1177/1090198111398129.

12. National Center on Parent Family and Community Engagement for the Office of Head Start. Using the Head Start Parent, Family, and Community Engagement Framework in Your Program. 2011.

13. Musher-Eizenman D, Holub S. Comprehensive Feeding Practices Questionnaire: validation of a new measure of parental feeding practices. J Pediatr Psychol. 2007;32(8):960-972. doi:10.1093/jpepsy/jsm037.

14. Amorim LD, Bangdiwala SI, McMurray RG, Creighton D, Harrell J. Intraclass correlations among physiologic measures in children and adolescents. Nurs Res. 56(5):355-360. doi:10.1097/01.NNR.0000289497.91918.94.

15. Rietmeijer-Mentink M, Paulis WD, van Middelkoop M, Bindels PJE, van der Wouden JC. Difference between parental perception and actual weight status of children: a systematic review. Matern Child Nutr. 2013;9(1):3-22. doi:10.1111/j.1740-8709.2012.00462.x.

16. Gesell SB, Scott TA, Barkin SL. Accuracy of perception of body size among overweight Latino preadolescents after a 6-month physical activity skills building intervention. Clin Pediatr (Phila). 2010;49(4):323-329. doi:10.1177/0009922809339386.

17. Perrin EM, Jacobson Vann JC, Benjamin JT, Skinner AC, Wegner S, Ammerman AS. Use of a pediatrician toolkit to address parental perception of children’s weight status, nutrition, and activity behaviors. Acad Pediatr. 10(4):274-281. doi:10.1016/j.acap.2010.03.006.

18. Stark LJ, Clifford LM, Towner EK, et al. A pilot randomized controlled trial of a behavioral family-based intervention with and without home visits to decrease obesity in preschoolers. J Pediatr Psychol. 2014;39(9):1001-1012. doi:10.1093/jpepsy/jsu059.

19. Bocca G, Corpeleijn E, Stolk RP, Sauer PJJ. Results of a multidisciplinary treatment program in 3-year-old to 5-year-old overweight or obese children: a randomized controlled clinical trial. Arch Pediatr Adolesc Med. 2012;166(12):1109-1115. doi:10.1001/archpediatrics.2012.1638.

20. Lumeng JC, Kaciroti N, Sturza J, et al. Changes in Body Mass Index Associated With Head Start Participation. Pediatrics. 2015;135(2):e449-e456. doi:10.1542/peds.2014-1725.

21. Poutahidis T, Kleinewietfeld M, Smillie C, et al. Microbial Reprogramming Inhibits Western Diet-Associated Obesity. PLoS One. 2013;8. doi:10.1371/journal.pone.0068596.

22. Davison KK, Jurkowski JM, Li K, Kranz S, Lawson HA. A childhood obesity intervention developed by families for families: results from a pilot study. Int J Behav Nutr Phys Act. 2013;10:3. doi:10.1186/1479-5868-10-3.

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