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ORIGINAL RESEARCH COMMUNICATION |
1 From Johns Hopkins University, Baltimore (BC and BE); the University of New Mexico, Albuquerque (TC and SMD); the University of Minnesota, Minneapolis (BHR and MS); the University of Arizona, Tucson (TL); the National Heart, Lung, and Blood Institute, Bethesda, MD (JN and EJS); the Gila River Indian Community (LS); and the University of North Carolina at Chapel Hill (JS).
2 Supported by National Heart, Lung, and Blood Institute grants U01-HL-50869, -50867, -50905, -50885, and -50907.
3 Address reprint requests to B Caballero, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205. E-mail: caballero{at}jhu.edu.
See corresponding editorial on page 904.
| ABSTRACT |
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Objective: The objective was to evaluate the effectiveness of a school-based, multicomponent intervention for reducing percentage body fat in American Indian schoolchildren.
Design: This study was a randomized, controlled, school-based trial involving 1704 children in 41 schools and was conducted over 3 consecutive years, from 3rd to 5th grades, in schools serving American Indian communities in Arizona, New Mexico, and South Dakota. The intervention had 4 components: 1) change in dietary intake, 2) increase in physical activity, 3) a classroom curriculum focused on healthy eating and lifestyle, and 4) a family-involvement program. The main outcome was percentage body fat; other outcomes included dietary intake, physical activity, and knowledge, attitudes, and behaviors.
Results: The intervention resulted in no significant reduction in percentage body fat. However, a significant reduction in the percentage of energy from fat was observed in the intervention schools. Total energy intake (by 24-h dietary recall) was significantly reduced in the intervention schools but energy intake (by direct observation) was not. Motion sensor data showed similar activity levels in both the intervention and control schools. Several components of knowledge, attitudes, and behaviors were also positively and significantly changed by the intervention.
Conclusions: These results document the feasibility of implementing a multicomponent program for obesity prevention in elementary schools serving American Indian communities. The program produced significant positive changes in fat intake and in food- and health-related knowledge and behaviors. More intense or longer interventions may be needed to significantly reduce adiposity in this population.
Key Words: Obesity American Indians schoolchildren prevention programs randomized trials
| INTRODUCTION |
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| SUBJECTS AND METHODS |
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Study population
School selection was based on the following eligibility criteria: 1) a projected 3rd grade enrollment of
15 children, 2)
90% of 3rd grade children of American Indian ethnicity, 3)
retention from 3rd to 5th grade over the past 3 y of
70%, 4)
school meals prepared and administered on site, 5) availability
of minimum facilities to deliver a physical activity program at
the school, and 6) approval of the study by school, community,
and tribal authorities. In addition, schools that were considering
closing or merging in the next 3 y were excluded.
A total of 41 schools in 7 American Indian communities were enrolled. All schools worked in partnership with a participating academic institution: White Mountain Apache and San Carlos Apache (Johns Hopkins University, Baltimore), Navajo (University of New Mexico, Albuquerque), Sicangu Lakota and Oglala Lakota (University of Minnesota, Minneapolis), and the Tohono O'odham Nation and Gila River Indian Community (University of Arizona, Tucson). The University of North Carolina at Chapel Hill served as the coordinating center.
Children were enrolled in the study, and baseline measurements were made at the end of the 2nd grade. To ensure that the average %BF was similar in both groups, schools were assigned to intervention and control groups by a process of stratified randomization. After the baseline measurements were made, upper and lower %BF strata were defined for schools at each site, and random allocation was determined for each stratum.
The study protocols were approved by tribal, school, and university authorities. Written informed consent was obtained from the parents, and verbal consent was obtained from the children for all measurement procedures and for intervention activities as required by school boards and tribal health authorities.
Intervention components
The Pathways Study intervention consisted of 4 components
(Table 1
): classroom curriculum, food service, physical activity, and family involvement. Each component was developed
and pilot-tested during the feasibility phase of the study and
was based on formative research performed at each site (11).
The intervention approach combined constructs from social
learning theory and principles of American Indian culture and
practices. Several indigenous learning modes (eg, story telling)
were also incorporated into the intervention (12).
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Food service
The food service intervention provided nutrient guidelines
and practical tools for reducing the fat content of school meals
while complying with nutrient requirements as defined by the
US Department of Agriculture School Lunch and Breakfast
programs. The Pathways Behavioral Guidelines for food service staff provided skill-building techniques for use in planning, purchasing, and preparing lower-fat school meals.
Physical education
The physical education (PE) program aimed at increasing
energy expenditure in the school environment by implementing
a minimum of three 30-minute sessions per week of moderate-to-vigorous physical activity. The PE program was based on
the SPARK (Sports, Play and Active Recreation for Kids)
program (13), with the addition of an American Indian Games
module. In addition, the program included exercise breaks of
2-10 min duration, which were designed to increase energy
expenditure and promote physical activity in the classroom.
Typically, these exercise breaks consisted of simple exercises
that could be performed in the classroom or outside, during
recess.
Family involvement
The goal of the family-involvement component was to introduce families to the Pathways intervention and to assist them
in creating a supportive environment for healthy behaviors.
The activities also offered families an interactive forum to
discuss practical aspects of the Pathways program and to extend their knowledge on healthy lifestyle and eating behaviors.
The family component consisted of 1) family action packs,
which were take-home materials related to the Pathways intervention, including snack packs with samples of low-fat foods
and tips for preparing healthful snacks at home; and 2) family
events at schools, which included cooking demonstrations and
activities for healthier lifestyle, with the direct involvement of
children.
Training
Each intervention component included a specific training
plan. Teachers and food service staff were trained annually in
local or regional meetings. Concepts and procedures were
reinforced at regular visits to school classrooms and kitchens.
PE teachers, aides, or regular teachers in charge of PE at each
intervention school were trained annually by licensed SPARK
instructors or by Pathways instructors who had experience in
delivering that program. These Pathways staff also acted as
mentors for PE teachers, offering regular support and filling in
for PE teachers when needed to ensure a minimum of PE every
week.
Measurements
To avoid operator bias, measurement teams were not involved in delivering the intervention. Training, certification,
and cross-validation of measurement staff were done centrally
or regionally, supervised by the Measurement Committee.
Anthropometry
A full set of anthropometric and body-composition data were
collected at baseline (end of 2nd grade) and at follow-up (end
of 5th grade). Interim measurements of weight and height were
also obtained annually, at the end of the school year, for use by
the Data Safety and Monitoring Board for safety monitoring.
Measurements were performed in a dedicated room at each
school while the children were wearing light clothing and no
shoes. All measurements were made early in the morning, on
arrival at school. Weight was measured with the use of self-calibrating precision digital scales (Seca 770; Vogel & Halke
GmbH, Hamburg, Germany) and height with a fixed Shorr
measuring board (Shorr Productions, Olney, MD). Two measurements were obtained and the average was recorded. Triceps and subscapular skinfold thicknesses were measured in
triplicate with Lange calipers. Bioelectrical impedance was
measured in duplicate with a single-frequency tetrapolar plethysmograph (Valhalla Scientific, Valhalla, NY). Calibration
of scales, calipers, and bioimpedance instruments were
checked before each use. Maximum acceptable ranges were
defined for all measurements.
Percentage body fat
%BF was estimated from bioelectrical impedance and anthropometry with the use of an equation developed and validated specifically for this study (14). This equation has been
shown to be highly predictive of %BF in American Indian
children (R2 = 0.84). In instances where
2 of the variables
used in the prediction equation were missing, a reduced equation (without the missing variables) was used to predict %BF if
the reduced equation produced an R2 of
0.7 for the prediction of %BF in the same data set used for development of the
full prediction equation. For all measurements, deviation from
a set range of the 2 measurements would trigger a repeat
measurement by the quality control supervisor. In addition,
every 10th child was measured a third time by the QC supervisor. Operators deviating from the supervisor's measurements
beyond a set range were excluded from further measurement
and sent to retraining.
Physical activity
Physical activity was measured with the use of both a motion
sensor and a self-reported activity questionnaire. Minute-by-minute recordings of vector magnitudes, measured with a 3-dimensional accelerometer (TriTrac R3D; Hemokinetics, Iowa
City) were collected for 24 h on a random sample of 15
children in each school at the end of the 2nd grade. At the end
of the 5th grade, measurements were taken on those same
children who were still enrolled; additional children were randomly selected at each school to replace those lost to
follow-up.
The physical activity questionnaire was designed to assess activity during the preceding 24 h with the use of a standardized checklist of activities that were selected during the feasibility phase of the study. An activity index was derived from estimates of the energy cost of each activity weighted by its duration (none, a little, a lot).
Knowledge, attitudes, and behavior
A questionnaire about knowledge, attitudes, and behavior
was developed and pilot-tested during the feasibility phase of
the Pathways Study to measure knowledge, attitudes, and behaviors related to diet and physical activity among American
Indian schoolchildren (15). Three scales assessed knowledge of
concepts taught in the Pathways curriculum in each grade (3rd,
4th, and 5th). The
coefficients of these scales, measured
during the feasibility phase in 5th grade children, were 0.54,
0.50, and 0.51, respectively. Additional scales assessed self-efficacy related to physical activity (
= 0.69), self-efficacy to
eating a healthy diet (
= 0.75), and healthy food intentions
(
= 0.74).
Questionnaires were distributed to children in their classrooms. Trained Pathways staff read aloud each question and the corresponding answer choices. Children followed along and marked their answers on the questionnaire.
Dietary intake
Food intake during school lunch was measured by direct
observation, as previously described (16). Groups of 2-3 children were observed during lunch, in a nonintrusive manner, by
2 trained Pathways staff. Food intake was calculated after all
food left on the tray was measured. Twenty-four-hour dietary
recall was performed only at the end of the study (5th grade),
because a pilot study performed during the feasibility phase
showed that 2nd graders could not provide reliable answers
about their food intake.
Menu data were collected from 38 schools for breakfast and from 41 schools for lunch, representing menus offered during a 5-d period. All meal-composition data were analyzed with the use of the Nutrition Data System at the University of Minnesota.
Process evaluation
Process evaluation was conducted annually by Pathways
investigators and staff not involved in the intervention. Eighteen survey instruments were used to cover all 4 components of
the intervention in the 21 intervention schools. Types of data
collected included attendance logs for training sessions (teachers, food service personnel, and PE instructors) and for family
event (parents or guardians), PE calendars, kitchen-visit contact forms, and student and parent evaluation forms (17). Interim results were used by the Steering Committee to track the
implementation of the intervention at each study site, and
aggregate results were used to evaluate the overall implementation of the program.
Study organization, data management, and safety
The study was coordinated by a Steering Committee that
included the principal investigators, the project officer (from
the National Heart, Lung, and Blood Institute), and 2 American
Indian representatives elected by all American Indian study
personnel. Scientific and ethical issues were monitored
throughout the duration of the study by an external Data Safety
and Monitoring Board.
Weight and height were measured annually to detect any potential adverse effects of the intervention on growth. Children with BMIs below the 5th percentile of the Centers for Disease Control and Prevention 2000 growth charts or with growth velocity below the 3rd percentile of Tanner's reference values (18) were identified. Parents were notified when their children met one of these criteria and were referred to the local primary care facility. Children with both low BMI and low growth velocity were followed up by letter, visit, or telephone call, and the principal of the school was notified. To monitor possible adverse effects of the PE intervention, all schools were asked to keep a log of physical activity-related injuries.
Statistical analysis
Mixed linear models were used to test for intervention effects, with %BF at the end of 5th grade as the primary outcome
variable. Fixed effects were baseline %BF and treatment group.
Field sites and schools within sites were treated as random
effects. Preliminary tests were done to identify possible site-by-treatment or sex-by-treatment interaction effects for the
main outcome variable, but none were statistically significant.
Therefore, mixed models with only main effects terms are
presented. Similar mixed models were constructed for the
secondary outcome variables. Some outcome variables were
not controlled for baseline values, either because no baseline
data were available (24-h dietary recall and knowledge of 4th
and 5th grade curricula) or because the repeated measurements
were not done in the same group of children (school lunch
observation and physical activity by motion sensor). The SAS
procedure PROC MIXED (SAS Institute, Cary, NC) was used
to estimate all the models.
The primary statistical analysis applied the intention-to-treat principle, which calls for all subjects to be analyzed according to their treatment assignment at the time of randomization, regardless of whether they complete the study or not. Therefore, imputed values were used for missing data at follow-up (5th grade). For this, a prediction equation was developed with the use of data from control schools (19) and a procedure based on Rubin's multiple imputation method (20). A secondary analysis was performed that included only students with both 2nd and 5th grade %BF measurements.
RESULTS
A flow chart for enrollment and follow-up is presented in
Figure 1
.
Of the 2059 2nd-grade students in the 41 participating schools, 1760 received parental permission to be measured
and 1704 were measured, which represented the number of
children who were actually present at the schools on measurements days. The mean age of children at baseline was 7.6 ±
0.6 y. Detailed results from baseline measurements are reported
elsewhere (21). All 41 schools completed the 3-y study. Of the
1704 children screened at baseline, 1409 (83%) were measured
at the end of the intervention period.
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7% in
both groups. Imputation of %BF for children who were lost to
follow-up did not change these results. With the use of data
from children who completed the study, the mean difference in
change in %BF between the intervention and control schools
was 0.2 (95% CI: -0.84, 1.31). After imputation this difference was 0.0 (95% CI: -0.85, 0.82).
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Dietary intake
The total energy intake and the percentage of energy from fat
as measured by 24-h dietary recall and direct observation of
children eating lunch at school are shown in Table 3
. The 24-h recall showed a significantly lower total daily energy intake
(1892 compared with 2157 kcal/d) and percentage of energy
from total fat (31.1% compared with 33.6%) in the intervention
group than in the control group. The data from school-lunch
observation confirmed a lower fat intake in the intervention
group but no difference in energy intake between the 2 groups.
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Physical activity
Results of the physical activity measures at baseline and
follow-up are presented in Table 3
. The motion sensor measurements indicated no significant difference over a 24-h period between the children measured in the intervention and
control schools. Self-reported physical activity levels (by Physical Activity Questionnaire) were higher among intervention-
than control-school students at the end of the trial (Table 3
). No
increase in PE-related injuries was detected in the intervention
schools on the basis of injury logs maintained by the schools
(data not shown).
Knowledge, attitudes, and behavior
Knowledge targeted in the 3rd, 4th, and 5th grade Pathways
curricula increased significantly in the children in the intervention schools compared with the control schools (Table 3
). The
difference tended to be largest for the information targeted in
the 3rd grade curriculum (intervention group: 0.77; control
group: 0.65). Self-efficacy to be physically active was higher in
the intervention group than in the control group; however, there
was no significant difference between the 2 groups in self-efficacy to choose healthy foods. Nevertheless, children who
received the intervention reported more healthy food choice
intentions than did control children.
Family participation
Intervention schools held 9 different family events throughout the 3 y. The events took place at each school and attracted,
on average, 59% of the children enrolled in the study, or 0.9
adults per child. Relative to anecdotal reports of parental attendance at other school events, this attendance level appeared
to be very good.
Process evaluation data indicated a strong degree of implementation for the classroom curriculum, with 94% of lessons completed. Seventy-eight percent of the food service guidelines were implemented, with a progression of 51%, 80%, and 87% for years 1, 2, and 3, respectively. The minimum of 3 PE sessions/wk was achieved by 81% of schools in the first year and by essentially 100% in years 2 and 3. However, only 56% of the schools reached the recommended goal of 5 sessions/wk. Average student attendance at family events over 3 y was 58%. The process evaluation data also indicated that a large majority of those attending family events enjoyed the activities and reported learning something new about diet, physical activity, and health.
| DISCUSSION |
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The primary aim of the study was to reduce the rate of body fat gain in intervention schools, documented by a significant difference in the rate for the control schools after 3 y. This goal was not reached, and %BF in both groups was essentially identical at the end of the intervention period.
Over the past 30 y, several school-based studies have implemented and evaluated programs aimed at reducing cardiovascular disease risk or obesity prevalence (22-34). Several of these programs were targeted at only obese children and thus did not attempt to modify risk behaviors in nonobese children. The results from true primary prevention interventions that included at least a dietary and a physical activity component show that most interventions were able, to a variable degree, to reduce dietary fat intake, increase physical activity during school time, increase consumption of fresh fruit and vegetables, and reduce television viewing (23, 31-34). However, these studies also indicate the resiliency of body weight and adiposity in this age group: virtually none of these interventions, which ranged in duration from 1 to 4 y, significantly reduced average body weight or adiposity in interventions. One of these studies, the Planet Health intervention (31), showed a significant reduction in obesity prevalence, defined by a combination of BMI and triceps-skinfold thickness, but only in girls.
A reduction in the rate of body fat accumulation in children
requires a net decrease in positive energy balance, leaving less
unspent energy available for storage as adipose tissue. This can
be achieved by reducing energy intak, increasing energy output
through physical activity, or both. Because our intervention
was aimed at all children at the school and not only at those
with excess body weight, restriction of energy intake was not
an option. Furthermore, the federal school lunch and breakfast
programs have minimum mandatory amounts of calories to be
served at school cafeterias. Thus, instead of targeting calories,
our food service intervention aimed at reducing the energy
density of foods by reducing their fat content and at increasing
the availability of less energy-dense foods, such as fresh fruit
and vegetables. These changes resulted in a significantly lower
percentage of energy as fat at lunch in the intervention schools
than in the control schools: 28.2% compared with 32.4% (Table 3
).
The 24-h dietary recall at the end of the study showed a
significantly lower total daily energy intake in the intervention
group,
150 kcal/d less than in the control group. Because
there were no significant differences in weight, adiposity, or
physical activity between the groups, this difference in energy
intake may be the result of reporting bias. Alternatively, the
reduction in energy intake in the intervention schools may have
occurred too late in the study to cause a significant difference
in body weight or adiposity by the time of the follow-up
measurement. Excess weight gain during the 3-mo summer
recess, which was not assessed, is another possible mechanism.
The second approach to reduce excess positive energy balance was to increase energy expenditure by increasing the time children spent in moderate-to-vigorous physical activity. By including physical activity breaks throughout the day, our physical activity intervention sought to increase the daily active time and reduce sedentary time, an approach positively associated with weight maintenance in reduced-obese children (35). Although the motion sensor data indicated a positive trend toward more active time in the intervention schools, this measurement did not confirm the significant increase in PE found by self-report on the questionnaire. Note that whereas the motion sensor data are a direct measurement of physical activity, the questionnaire provides the self-reported frequency of a limited number of activities.
The significant effect of the intervention on the fat content of the school menus and the dietary fat intake of children show that a reduction in caloric density and in the consumption of saturated fat are feasible while maintaining adequate total energy and micronutrient intakes. Food preparation techniques to reduce fat content and the introduction of low-fat products were ultimately widely accepted by children and by food service personnel. However, these changes were only progressively implemented, and only 51% of scheduled guidelines were implemented during the first year of the intervention.
In summary, the Pathways Study showed that significant reductions in the fat content of school menus and in the dietary fat intake of children can be achieved by training and supporting food service staff. The study also showed that properly trained teachers can achieve significant changes in the health-related knowledge and behaviors of 7-10-y-old children with the use of a culturally appropriate classroom curriculum. The intervention showed positive but no statistically significant trend in the level of physical activity during school time. The lack of effect of the intervention on %BF suggests that more intense or longer interventions may be needed to modify the continuing trend toward higher adiposity in this population.
| ACKNOWLEDGMENTS |
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All authors were members of the study's Steering Committee and had direct responsibility, as principal investigators or field center coordinators, for the oversight of the study, including its design and the collection and interpretation of data. JS and the staff at the study's coordinating center were responsible for data processing and analysis. BC drafted this manuscript, which was reviewed and approved by all authors. None of the authors had financial interests related to this study.
Personnel at each of the participating field centers are as follows. Gila River Indian Community and University of Arizona (Tohono O'odham): Larry Stephenson and Timothy Lohman (Principal Investigators), K Booth, C Cornell, J Ekland, Scott Going, H Flint-Wagner, J Martin, L Metcalfe, L Nielson, Juanita Pablo, and J Weber; Johns Hopkins University (White Mountain Apache Tribe and San Carlos Apache Tribe): Benjamin Caballero (Principal Investigator and Chair, Steering Committee), Jean Anliker, Ronald Alsenay, Jackie Altaha, Joelian Armstrong, Lucie Billie, Becky Ethelbah, Joel Gittelsohn, Stacy Gyenizse, Corleone Hastings, Delta Hinton, Sheri Kessay, Lydia Kinney, David Nelson, and Ray Reid. University of Minnesota (Oglala Sioux Tribe and Rosebud Sioux Tribe): Mary Story (Principal Investigator), John Himes, Lisa Harnack, Bonnie Holy Rock, Mary Smyth, Pat Snyder, Wilbur Ferguson, Pam Livermont, Mary Jane Steele, Dawn Rassmusson, Patty Iron Cloud, Cordelia White Elk, Travis Goings, Liz Kingi, and Mona Massingale. University of New Mexico (Navajo Nation): Sally M Davis (Principal Investigator), Vivian Arviso, Catherine Axtell, Elverna Bennett, Brenda Broussard, Theresa Clay, Dustin Cole, Leslie Cunningham-Sabo, Michelle Curtis, Anne Doering, David Fenn, Willow Foster, Blanche Harrison, Karen Heller, Francesca Lanier, Raylene McCalman, Will McCoy, Cindy McKay Chavez, Rachel Middleman, Lydia Montoya, Marla Pardilla, Shirley Pareo, Harrison Platero, Stephanie Rider Pier, Nancy Risenhoover, Jennifer Schoenberg, Betty Skipper, Janice Thompson, Leslie Trickey, and Venita Wolfe. University of North Carolina at Chapel Hill (Coordinating Center): June Stevens (Principal Investigator), Ed Davis, Allan Steckler, Chirayath Suchindran, Richard Brice, Brad Black, Nancy Cohn, Kim Ring, Dawn Stewart, and Mal Foley. National Heart, Lung, and Blood Institute: Marguerite Evans, Richard Fabsitz, Sally Hunsberger, Jared B Jobe, James Norman, and Elaine Stone.
Members of the Data Safety and Monitoring Board are as follows: Philip Nader (Chair; University of California, San Diego), Tom Baranowski (Baylor College of Medicine, Linda Burhansstipanov, Pine, CO), Allan Donner (University of Western Ontario), Sue YS Kimm (University of Pittsburgh), Barbara Shannon (Pennsylvania State University).
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A. L. Carrel, R. R. Clark, S. E. Peterson, B. A. Nemeth, J. Sullivan, and D. B. Allen Improvement of Fitness, Body Composition, and Insulin Sensitivity in Overweight Children in a School-Based Exercise Program: A Randomized, Controlled Study Arch Pediatr Adolesc Med, October 1, 2005; 159(10): 963 - 968. [Abstract] |