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 are more 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 provider to 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 include references, 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
under study 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
mentor or a 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
without any studies comparing their effectiveness. We will assess socioeconomic factors in order to address
potential confounding at the center level given the cluster randomization.
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Sosa, Erica and Foster, Byron A
5. Description of Participants and Participating Study Site(s): Describe the relevant demographic characteristics of the
participants who are the target of the intervention, including how 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 practices13 and 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 the intra-class correlation 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.16,17 We 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
9. Sample Size: Provide the total sample size for the main CER analysis and the number per arm (N1, 2, 3, 4 . . .), as
applicable.
PCORI Spring 2015 Cycle: Letter of Intent Template
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Sosa, Erica and Foster, Byron A
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 its inclusion 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.10,21,22 Parent 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.
PCORI Spring 2015 Cycle: Letter of Intent Template
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Sosa, Erica and Foster, Byron A
References:
1.
Carnell S, Edwards C, Croker H, Boniface D, Wardle J. Parental perceptions of overweight in 3-5 y olds. Int J Obes
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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.
PCORI Spring 2015 Cycle: Letter of Intent Template
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Sosa, Erica and Foster, Byron A
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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.
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20.
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21.
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