Pediatrician-led Motivational Interviewing to Treat
Overweight Children: An RCT
WHAT’S KNOWN ON THIS SUBJECT: Obesity and overweight can seriously affect health outcomes. Many obesity prevention interventions have been proposed, but few have been effective. Motivational interviewing in primary care seems promising, but results in BMI control are controversial and require further investigation.
WHAT THIS STUDY ADDS: This is thefirst study to demonstrate the effectiveness of pediatrician-led motivational interviewing for BMI control in overweight children aged 4 to 7 years.
Nevertheless, no effect was observed in boys or when the mother’s education level was low.
abstract
OBJECTIVE:The aim of this study was to evaluate the effect of family pediatrician–led motivational interviews (MIs) on BMI of overweight (85th$BMI percentile$95th) children aged 4 to 7 years.
METHODS:All the family pediatricians working in Reggio Emilia Prov-ince (Italy) were invited to participate in the study; 95% accepted. Spe-cific training was provided. Parents were asked to participate in the trial if they recognized their child as overweight. Children were indi-vidually randomly assigned to MIs or usual care. All children were in-vited for a baseline and a 12-month visit to assess BMI and lifestyle
behaviors. The usual care group received an information leaflet,
and the intervention group received 5 MI family meetings. The primary outcome was the individual variation of BMI, assessed by pediatricians unblinded to treatment groups.
RESULTS:Of 419 eligible families, 372 (89%) participated; 187 children were randomized to MIs and 185 to the usual care group. Ninety-five percent of the children attended the 12-month visit. The average BMI increased by 0.49 and 0.79 during the intervention in the MI and control groups, respectively (difference:–0.30; P= .007). MI had no effect in boys or in children whose mothers had a low educational level. Positive changes in parent-reported lifestyle behaviors occurred more frequently in the MI group than in the control group.
CONCLUSIONS: The pediatrician-led MI was overall effective in controlling BMI in these overweight children aged 4 to 7 years, even though no effect was observed in male children or when the mother’s education level was low.Pediatrics2013;132:e1236–e1246
AUTHORS:Anna Maria Davoli, MD,aSerena Broccoli, PhD,b
Laura Bonvicini, MSc,bAlessandra Fabbri, MD,cElena Ferrari, MD,aStefania D’Angelo, MSc,dAnnarita Di Buono, MD,aGino Montagna, MD,aCostantino Panza, MD,aMirco Pinotti, MD,eGabriele Romani, MD,eSimone Storani, PhD,f Marco Tamelli, PhD,fSilvia Candela, MD,band Paolo Giorgi Rossi, PhDb
aPrimary Care Pediatrician,bEpidemiology Unit,cPublic Health
Nutrition Unit, andePrimary Health Care, Local Health Authority, Reggio Emilia, Italy;dMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, United Kingdom; andfPromotion Health Researchers, League Against Cancer, Reggio Emilia, Italy
KEY WORDS
BMI, motivational interview, overweight children, pediatrician, randomized controlled trial
ABBREVIATIONS
DBMI—BMI score variation CI—confidence interval MI—motivational interview PA—physical activity RE—Reggio Emilia
Obesity is 1 of the leading causes of morbidity and mortality in the in-dustrialized world,1 with being
over-weight and obese during childhood having well-documented short- and long-term physical and psychosocial health implications.2–4 Obesity in children is
recognized as a complex, multifactorial
problem. Weiss et al5 discussed a
“toxic obesity-inducing environment”that should be counteracted through family-, school-, and community-based inter-ventions. There is general agreement that the damage and the cost of rem-edies increase with age, and that efforts should concentrate on early childhood obesity prevention. Furthermore, inter-ventions should target the widest possi-ble range of population groups because the lowest socioeconomic groups are the most likely to suffer from the problem6
but are also the most difficult to reach.
Primary care providers7,8 and family
pediatricians, in particular, may be an effective point of contact for early pre-vention, but their involvement is not so obvious. In fact, screening and tracking BMI percentile according to age and
encouraging healthy nutrition and
physical activity (PA) are recommended but are not universally delivered in pe-diatric care.9–11 Although most
pedia-tricians want to prevent obesity, few believe there are any effective
treat-ments once a child is overweight.9
Practitioners often rely on their pro-fessional judgment or on adult di-agnostic criteria to identify pediatric obesity because they are unaware of, or lack access to, the appropriate di-agnostic tools and guidelines.12There is
evidence, however, that pediatricians who attended continuing medical edu-cation courses on obesity were more likely to use BMI-percentiles and had higher self-efficacy in practices related to childhood and adolescent overweight and obesity.9,13
Systematic reviews have found strong ev-idence that childhood obesity prevention
programs can reduce BMI, par-ticularly those programs targeting children aged 6 to 12 years compared with those targeting teenagers.14They
have also shown that a behavioral ap-proach to changing lifestyle in children15
or multisetting strategies7can produce
significant and clinically meaningful weight reduction in children compared with standard care or self-help.16Some
studies also highlight the need to pay attention to parental influence,17
espe-cially for younger children,18as parents
are sometimes unconcerned about their child’s weight status19and they may not
believe that excess weight gain can negatively affect their child’s health.4
Expert Committee recommendations15
suggest the use of patient-centered counseling techniques such as motiva-tional interviewing, which helps families identify their own motivation for making changes. The US Preventive Services Task Force recommends screening chil-dren aged$6 years for obesity and re-ferring to behavioral interventions. The task force found that effective compre-hensive weight-management programs
incorporated counseling and other
interventions that targeted diet and PA.20
Despite the strength of the
recom-mendations in guidelines,15,20 many
studies found small or no impact of motivational interviews (MIs) on BMI on overweight21–27or on obese children.28–30
Therefore, it is still necessary to test the effectiveness of the interventions in any context, when possible by using randomized controlled trials.31
Based on the available literature, we developed a family pediatrician–led MI targeting diet and PA behaviors to control BMI in overweight children aged 4 to 7 years. Obese children were
referred to specialized care.15 The
objective of the current paper was to present the results of an individually randomized trial designed to evaluate the effect of the MI intervention on BMI.
METHODS
Study Design and Study Setting
We conducted an individually random-ized controlled, parallel-group trial in the province of Reggio Emilia (RE), Italy, from June 2011 to June 2012. The RE Province had a resident population of 530 543 on January 1, 2011; 15.2% were children 0 to 14 years old,32assisted by
82 public health service family pedia-tricians. Routine visits are scheduled yearly up to age 6 years and then every 2 years until age 14 years for all chil-dren. In 2010, the estimated prevalence of overweight children was 22%.33
Participants
During 2010, all pediatricians of the RE Province opportunistically screened children aged 3 to 14 years for BMI and identified 7396 overweight and obese children (13% of the resident pop-ulation; 22% of the children scheduled for a visit in that target age group according to guidelines [yearly visits up to age 6 years and then a visit every 2 years]). In June 2011, a maximum of 12 overweight children (based on the 2010 survey results) for each pediatrician who agreed to participate in the study were randomly selected for eligibility assessment by the Epidemiology Unit.
Pediatricians scheduled baseline visits for eligibility assessment. Eligible partic-ipants were all overweight children (85th $BMI percentile$95th)34between 4 and
habits, specific dietary habits, and PA. Only those who demonstrated no interest in changing with regard to any of these topics were excluded. The study protocol was approved by the local ethics com-mittee, and the parents provided written informed consent for participation.
Randomization
Eligible children whose parents signed the informed consent form were cen-trally allocated to intervention or con-trol groups according to a randomization list created by the Epidemiology Unit by using the package RALLOC (Stata version 11.0; Stata Corp, College Station, TX).35
Due to the practical constraints of a maximum of 3 treated children per pediatrician, different allocation rules were used according to the number of eligible children. To balance allocation within strata, observations were oppor-tunely weighted (Appendix). Each pedia-trician was informed of the group allocation by means of a corporate In-tranet Web form customized for the trial (Supplemental Tutorial).
Interventions
Before enrollment began, all pedia-tricians attended a 4-hour training course on how to accurately measure weight and height and how to calculate BMI percentile, as well as a 20-hour training course on MI conducted by specialized psychologists from“Luoghi di Prevenzione,”the regional reference center for training in health pro-motion.36 Participating pediatricians
attended all of the training hours.
During the baseline visit, a pre-intervention questionnaire on dietary habits and PA was individually admin-istered to all children and their parents ([Supplemental Instrument Q]). Weight, height, BMI and BMI percentile,34and
additional variables relating to socio-demographic characteristics of chil-dren and parents were also collected. The same information was collected
at afinal visit 12 months after the in-tervention.
For masking purposes, children who were randomly assigned to the control group received a booklet with the main information on obesity prevention. During the year of intervention, they received the usual care currently of-fered by pediatricians to overweight children (ie, opportunistic advice if the pediatrician is seeing the child for other reasons).
A family pediatrician–led MI was offered to children assigned to the intervention group consisting of 5 individual meet-ings based on the transtheoretical model of addiction and behavior change (Table 1).37The child and parents always
had to leave the meeting having agreed on 2 objectives (1 concerning food and 1 concerning PA improvements) that were clearly defined and achievable. During each subsequent interview, the degree of achievement of the objectives set at the previous meeting was assessed; the objectives were then reinforced or redefined and recorded accordingly (tools used in MIs in Sup-plemental Instruments A–E).
Outcomes
The primary outcome was the individual BMI score variation (DBMI), as sug-gested by Cole et al.38BMI score was
calculated as the weight (kilograms) divided by the square of height (meters). TheDBMI was calculated as the within-child difference between BMI score at 12 months and at
base-line. BMI z scores and changes from
overweight status to normal weight or obesity were also reported to allow comparability with previous studies.
Secondary outcomes were the per-centage of positive changes in parent-reported dietary behaviors and in PA. These factors were measured by using the questionnaire. Both primary and secondary outcomes were assessed by the pediatricians without any blinding.
Sample Size
To detect a between-group difference in DBMI of at least 0.5 with a 5% signifi -cance level and a power of 90%,
as-suming an SD ofDBMI of 1, a sample
size of 85 children per group was necessary. Considering a 30% dropout rate, recruitment of at least 110 chil-dren per arm was planned.
Statistical Methods
To perform an intention-to-treat analy-sis for the primary objective, missing values forDBMI were replaced with the mean variation of BMI calculated in the control group. All inferential analyses were performed by using weights to balance allocation within strata
(Ap-pendix). Mean BMI and BMI z scores
with relative 95% confidence intervals (95% CIs) are presented. Differences in theDBMI between the intervention and control groups were analyzed by using
the nonparametric
Wilcoxon-Mann-Whitney test because outcome was not normally distributed.
The difference between the control and intervention groups in thefinal
distri-bution of healthy weight (5th #BMI
percentile #84th), overweight (85th
#BMI percentile #94th), and obese
(BMI percentile $95th)22 was tested
withx2for linear trend.
Multilevel linear models were performed to test the influence of pediatricians on intervention effectiveness. Two multilevel models (children, pediatricians) were specified: random intercept and random intercept and slopes.39 The intraclass
correlation coefficients are reported with the likelihood ratio tests to com-pare the models.
parent-reported PA and parent-parent-reported di-etary habits were tested by using the Wilcoxon rank sum test.
The statistician was not blinded to group assignments. The statistical significance level was set at 5%, and all analyses were performed by using Stata 11.0.40
RESULTS
Of the 82 pediatricians working in the RE Province in 2010, only 4 declined to participate in the trial; the remaining all completed training for BMI measure-ment and MI (Fig 1). Children were recruited from June to August 2011. Of the 795 children sampled among those who proved to be overweight accord-ing to the 2010 survey, 69 (8.7%) did not attend the eligibility assessment visit. Out of the 726 children who were con-tacted 307 (42.3%) were not eligible, primarily because either they were no longer overweight (n= 262 [36%]) or because the family was in a pre-contemplative stage (n= 81 [11%]). Of the 419 eligible children, 372 (88.8%) agreed to participate; 187 were ran-domly allocated to the intervention group and 185 to the control group. A median of 6 children (3 per treat-ment group) per pediatrician were included.
Of the 372 enrolled children, 95% completed the 2 visits for the control group and 5 visits for the intervention group. The median time between the baseline visit and the 12-month visit was 385 (25th–75th percentile: 355.5–396) days in the intervention group and 384 (25th–75th percentile: 358–396.5) days in the control group.
Baseline characteristics of children
and pediatricians are presented
overall and according to study group (Table 2, Supplemental Table 7). The baseline characteristics of the chil-dren who did not complete the study did not differ from those who did complete the study.
Primary Outcome
There was a significant difference in
DBMI between the intervention and
control groups (P = .007) (Table 3).
According to standardized growth
charts,34the expected variation of BMI
score in 12 months for overweight (90th BMI percentile) 6-year-olds is 0.60 for male subjects and 0.70 for female subjects; these data are similar to the control group results (0.79 [95% CI: 0.61–0.97]). The variation in the in-tervention group was lower than
expected, however (0.49 [95% CI: 0.29– 0.68]). Consistently, shifts from over-weight to normal over-weight were more frequent and shifts to obesity were less frequent in the intervention group compared with the control group. Differences were not statistically significant (x2 for trend, P = .169) (Table 4).
The proportion of the pediatrician-level variance on the overall variation in
DBMI (intraclass correlation
co-efficient) was 7.73%. The meanDBMI in
the control group was significantly
different across pediatricians
(likeli-hood ratio test – random-intercept
versus linear-regression model:x2[2]=
8.63, P = .013). The effectiveness of MI did not vary significantly across pediatricians (likelihood ratio test – random-intercept and slopes versus random-intercept model:x2[2]= 0.86,P=
.645).
The MI effect onDBMI was stronger in
girls (interaction test P = .072),
whereas there was almost no effect in
FIGURE 1
boys. The interaction was even stron-ger for mother’s education level (in-teraction test P = .008); for children
whose mother’s education level was
low, we observed a slightly non-significant, negative effect. The effect
was homogeneous in children aged,6
years and$6 years (Table 5).
Secondary Outcomes
Compared with controls, children in the intervention group strongly increased
nonorganized parent-reported PA and
slightly decreased parent-reported
time spent watching television (Table 6, Supplemental Fig 2).
Concerning parent-reported dietary habits (Table 6, Supplemental Fig 3), many more positive changes were ob-served in the intervention group than in the control group with regard to salty snacks, desserts, sweet snacks or candies, and sweetened drinks, and, to a lesser extent, for consumption of
vegetables, vegetable soups, and fried food.
DISCUSSION
Children who received MI had a sig-nificantly lower increase in BMI than did the control group; BMI increased on average by 0.49 in the intervention group and by 0.79 in the control group. MI was more effective among girls and was not effective among those children
TABLE 2 Enrolled Children’s Baseline Characteristics According to Group and Compliance at Follow-up
Baseline Characteristic Intervention Usual Care
Randomized (n= 187) Withdrawals (n= 11) Randomized (n= 185) Withdrawals (n= 6) Gender
Male 75 (40.1) 4 (36.4) 68 (36.8) 2 (33.3) Female 112 (59.9) 7 (63.6) 117 (63.2) 4 (66.7) Breastfeeding
Yes 119 (63.6) 6 (54.5) 126 (68.1) 5 (83.3) No 62 (33.2) 4 (36.4) 49 (26.5) 1 (16.7) Missing data 6 (3.2) 1 (9.1) 10 (5.4) 0 (0.0) Overweight before 5 y
Yes 119 (63.6) 6 (54.5) 119 (64.3) 1 (16.7) No 62 (33.2) 5 (45.5) 57 (30.8) 3 (50.0) Missing data 6 (3.2) 0 (0.0) 9 (4.9) 2 (33.3) Term birth
Yes 174 (93.0) 11 (100.0) 174 (94.1) 5 (83.3) No 10 (5.3) 0 (0.0) 6 (3.2) 1 (16.7) Missing data 3 (1.6) 0 (0.0) 5 (2.7) 0 (0.0) Small for gestational age
Yes 11 (5.9) 0 (0.0) 11 (5.9) 0 (0.0) No 171 (91.4) 11 (100.0) 168 (90.8) 5 (83.3) Missing data 5 (2.7) 0 (0.0) 6 (3.2) 1 (16.7) At least 1 immigrant parent
No 159 (85.0) 7 (63.6) 164 (88.6) 2 (33.3) Yes 23 (12.3) 2 (18.2) 15 (8.1) 2 (33.3) Missing data 5 (2.7) 2 (18.2) 6 (3.2) 2 (33.3) Father’s educational level
,13 y of school 92 (49.2) 5 (45.5) 82 (44.3) 3 (50.0) 13 y of school 71 (38.0) 3 (27.3) 82 (44.3) 1 (16.7)
.13 y of school 20 (10.7) 1 (9.1) 15 (8.1) 0 (0.0) Missing data 4 (2.1) 2 (18.2) 6 (3.2) 2 (33.3) Mother’s educational level
,13 y of school 63 (33.7) 5 (45.5) 58 (31.4) 3 (50.0) 13 y of school 97 (51.9) 3 (27.3) 98 (53.0) 1 (16.7)
.13 y of school 24 (12.8) 1 (9.1) 23 (12.4) 0 (0.0) Missing data 3 (1.6) 2 (18.2) 6 (3.2) 2 (33.3) Overweight/obese father
Yes 54 (28.9) 3 (27.3) 46 (24.9) 0 (0.0) No 102 (54.5) 4 (36.4) 118 (63.8) 6 (100.0) Missing data 31 (16.6) 4 (36.4) 21 (11.4) 0 (0.0) Overweight/obese mother
Yes 73 (39.0) 3 (27.3) 73 (39.5) 3 (50.0) No 95 (50.8) 5 (45.5) 95 (51.4) 3 (50.0) Missing data 19 (10.2) 3 (27.3) 17 (9.2) 0 (0.0) Age, mean6SD, y 6.760.99 6.661.02 6.561.15 6.160.39 BMI-percentile 50th (25th–75th) 92 (88–93) 93 (86–94) 92 (88–94) 90 (87–94)
whose mothers had a low level of ed-ucation. As shown by the BMIzscores, an increase in BMI does not imply a negative result because from ages 6 to 7 years, BMI curves increase.34,41
To our knowledge, only a few studies have evaluated the efficacy of MI con-ducted in the primary care setting in preventing obesity,27,29 and none has
found a positive effect on BMI outcome. The main limits declared by authors include short program duration (,12 months),21,26high drop-out rates,21,22,25
nonrandomized or clustered random-ized designs,21,22,25and the absence of
a “standard care only” group.26 Our
study overcomes these limits; the pro-gram lasted 12 months, there was ex-cellent compliance (95.4%), and it was a population-based, individually ran-domized trial. Patrick et al23 found
limited effects of a primary care and home-based MI intervention among a group of generally healthy (not only overweight) adolescents. Conversely, a subsequent study suggested that
a primary care–based MI was effective in preventing obesity in children aged 2 to 6 years; Taveras et al22found a small
(not significant) effect on BMI in the whole population (20.21;P= .15), with a significant effect among girls (20.38;
P = .03). Unlike the current study
results, they found that the
in-tervention was more effective in low-educated and low-income families. The low mean age of the enrolled children (4.9 years), the fact that counseling was conducted by pediat-ric nurses, and that 3 of the 7 inter-views were conducted via telephone are the main differences compared with our study.
Other types of interventions conducted in the primary care setting have been demonstrated to be feasible but not effective, at least not regarding the BMI outcome.42Only Keller et al43found that
a low threshold intervention in children aged 4 to 7 years at risk for obesity conducted at home by pediatricians stabilized the BMI of treated children. The BMI of children randomized in the intervention group who were not in-terested in participating and the BMI of children in the control group increased over the 1-year observation period. Programs that include individual MI not conducted by health care workers have not been effective in reducing BMI in female teenagers.31,44
Analyzing the secondary outcomes, we can argue that the effect of MI on BMI control is due to the impact of the treatment on the children’s lifestyle. In fact, the parent-reported eating habits and parent-reported PA of treated children also improved, confirming the hypothesized causal chain.
Nevertheless, the variations in BMI score did not correspond to a signifi -cant increase in the percentage of healthy-weight children. The clinical relevance of such a reduced increase in BMI should be assessed; we know that there is a dose-response relation be-tween BMI in childhood and the risk of obesity and diabetes in adulthood,45,46
and we can assume that any differ-ence in BMI implies a differdiffer-ence in health outcomes. However, the clini-cal relevance of a reduction in 1-year BMI increase of 0.30 is not obvious. A
Cochrane Review14 considered the
estimated BMI reduction of 0.15, cal-culated in predominantly non-overweight children aged 6 to 12 years, a“small but clinically important shift in population BMI.”
Our study had several strengths as well as some limitations. Compliance to the 1-year intervention was high, even for a population-based study involving al-most all the pediatricians in the RE Province and a relevant sample of their overweight patients. Therefore, this is a pragmatic trial, in which efficacy matched effectiveness: we measured exactly what should be done when the intervention is implemented as a regular practice; we know that the intervention is sustainable as a regular practice in primary care; and we know that time and costs are compatible with the daily ac-tivities of the pediatrician.
All pediatricians received standardized, complete training. Other studies high-lighted situations in which
pedia-tricians reported low confidence in
their ability to counsel.21,47In our study,
positive feedback came from the health
TABLE 3 BMI Score, BMIzScore,DBMI Score (Primary Outcome), andDBMIzScore According to
Study Group
Outcome Intervention Usual Care Between-Group Difference in
DBMI Score andzScore Mean 95% CI Mean 95% CI
Baseline
BMI score 18.28 18.16 to 18.39 18.21 18.09 to 18.32 BMIzscore 1.35 1.32 to 1.38 1.35 1.32 to 1.37 12-mo
BMI score 18.76 18.53 to 18.99 19.00 18.78 to 19.22 BMIzscore 1.24 1.17 to 1.31 1.34 1.28 to 1.40
Mean 95% CI
DBMI score 0.49 0.29 to 0.68 0.79 0.61 to 0.97 20.30a –0.57 to–0.04
DBMIzscore 20.11 –0.17 to–0.05 0.01 –0.06 to 0.05 20.10 –0.18 to–0.03
aWilcoxon-Mann-Whitney testP= .007 (predefined statistical test according to study protocol).
TABLE 4 Number (%) of Children According
to Group and BMI Weight Category at the 12-Month Follow-up Visit
BMI Weight Category
care professionals involved. However, families involved were only those de-termined to change (89% of the fami-lies with overweight children in this study).
Although the measured components of the outcome were not affected by subjectivity, we cannot rule out that an ascertainment bias occurred. In fact, the pediatrician was simultaneously the outcome assessor for both arms and the intervention provider for the experimental arm. A bias toward an overestimation of the effect is therefore
more relevant for PA and dietary habits, in which both the lack of independence of the assessor and a social desirability bias could move in this direction.
Long-term follow-up is required to verify the duration of results over time, as advocated by the literature.14,17A
follow-up visit is planned after June 2013, which is 1 year after the end of the study.
Finally, our intervention was almost completely ineffective in boys and in children whose mothers have low ed-ucational level. The implementation of such an intervention might therefore
have the paradoxical effect of increasing health inequalities because low socio-economic status is already associated with obesity in Italy,48as it is in many
other industrialized countries.49
CONCLUSIONS
A family pediatrician–led MI was ef-fective in BMI control for overweight children aged 4 to 7 years. According to the population-based design, the in-tervention is feasible and affordable. However, further efforts are needed to understand why it is not effective for male subjects and for children whose mothers have less education. Our results, considered in light of the het-erogeneity of previous studies, further stress the need to conduct pragmatic trials to test the effectiveness of simi-lar interventions in any social and cultural contexts.
ACKNOWLEDGMENTS
We are grateful to all pediatricians working in the RE Province for their par-ticipation in this project. Their work and attention to details contributed to the success of the study. We thank Paola Albertini (Local Health Authority RE) for her support and assistance in pro-viding the corporate Intranet Web form customized for the trial. We are also grateful for the highly constructive comments of the reviewers and the ed-itor.
TABLE 5 DBMI According to Children’s Age, Gender, Mother’s Education Level, and Study Group
Subgroup DBMI Between-Group Difference in
DBMI
Interaction Test Intervention Usual Care
Mean 95% CI Mean 95% CI Mean 95% CI Gender
Male 0.77 0.46 to 1.07 0.77 0.44 to 1.10 20.01 –0.45 to 0.44 P= .072 Female 0.29 0.05 to 0.54 0.80 0.59 to 1.02 20.51 –0.83 to–0.19
Age
,6 y 0.46 0.13 to 0.78 0.77 0.43 to 1.11 20.31 –0.78 to 1.15 P= .961
$6 y 0.50 0.26 to 0.74 0.80 0.59 to 1.01 20.30 –0.62 to 0.02 Mother’s educational level
,13 y of school 0.86 0.49 to 1.23 0.65 0.33 to 0.97 0.21 –0.28 to 0.69 P= .008 13 y of school 0.34 0.13 to 0.56 0.86 0.61 to 1.11 20.52 –0.84 to–0.19
.13 y of school 20.20 –0.71 to 0.30 0.84 0.31 to 1.36 21.04 –1.75 to–0.33
TABLE 6 Number (%) of Changes (None, Positive, or Negative) in Parent-Reported PA and Dietary
Habits According to Study Group
Habit Pre/Post Intervention Changes Pre/Post Usual Care Changes Pa
Negative None Positive Negative None Positive No. % No. % No. % No. % No. % No. % PA habits
Organized PAb 15 8.6 120 69.0 39 22.4 15 8.6 121 69.1 39 22.3 .964 Nonorganized PAb
22 12.6 91 52.3 61 35.1 42 24.0 89 50.9 44 25.1 .007 Screen timec
14 8.0 126 72.4 34 19.5 20 11.5 131 75.3 23 13.2 .056 Dietary habits
Having breakfastb
14 8.1 130 75.1 29 16.8 14 8.1 139 80.8 19 11.0 .233 Fruitb
30 17.2 83 47.7 61 35.1 33 18.9 89 50.9 53 30.3 .432 Vegetablesb
32 18.4 76 43.7 66 37.9 30 17.2 102 58.6 42 24.1 .073 Vegetable soupb
13 7.5 130 74.7 31 17.8 22 12.6 134 76.6 19 10.9 .023 Dessertsc
22 12.6 89 51.1 63 36.2 34 19.4 95 54.3 46 26.3 .012 Fried foodc
17 9.8 117 67.2 40 23.0 21 12.0 129 73.7 25 14.3 .05 Salty snacksc
18 10.3 110 63.2 46 26.4 26 14.9 114 65.1 35 20.0 .081 Sweet snacks/candiesc 18 10.4 62 35.8 93 53.8 36 20.6 80 45.7 59 33.7 ,.001 Sweetened drinksc 14 8.0 80 46.0 80 46.0 30 17.1 89 50.9 56 32.0 ,.001
aPvalues represent the probability that the direction of changes is not different in the 2 groups. It has been computed through a Wilcoxon rank sum test comparing the rank of changes in the 2 groups according to the categories (0, 1–3, 4–5,.5, 1/day, more) answers in the questionnaire.
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(Continued fromfirst page)
Dr Davoli designed the study, coordinated and supervised the pediatricians, and drafted the introduction and discussion of the manuscript; Dr Broccoli contributed to designing the study, coordinated and supervised thefirst months of data collection, conducted the analyses, and drafted the methods and results of the manuscript; Dr Bonvicini contributed to designing the study, coordinated and supervised thefinal months of data collection, conducted the analyses, and reviewed and revised the manuscript; Dr Fabbri contributed to designing the study, supervised the data collection, analyzed the results, and reviewed and revised the manuscript; Dr Ferrari contributed to designing the study, coordinated and supervised the recruitment phase, and collaborated in pediatricians’training and study conduction; Dr D’Angelo supervised thefinal months of data collection and reviewed the manuscript; Dr Di Buono contributed to designing the study, and coordinated and supervised the recruitment phase; Dr Montagna contributed to designing the study, coordinated and supervised the recruitment phase, collaborated in study conduction, and directed the pediatricians’involvement (pediatricians’component); Dr Panza contributed to study conception and design, and conducted the preliminary systematic review of the interventions for obesity prevention in children; Dr Pinotti contributed to study conception and directed the pediatricians’involvement (local health unit component); Dr Romani coordinated the implementation of the intervention and conducted the recruitment phase with pediatricians; Drs Storani and Tamelli contributed to designing the intervention and trained the pediatricians; Dr Candela conceived the study, contributed to designing the study, and reviewed and revised the manuscript; and Dr Giorgi Rossi planned the data analysis, drafted the outline of the manuscript, and critically reviewed and revised the manuscript. All authors approved thefinal manuscript as submitted.
This trial has been registered at www.clinicaltrials.gov (identifier NCT01822626). www.pediatrics.org/cgi/doi/10.1542/peds.2013-1738
doi:10.1542/peds.2013-1738
Accepted for publication Aug 23, 2013
Address correspondence to Serena Broccoli, PhD, Epidemiology Unit, Local Health Authority of Reggio Emilia, via Amendola 2, Reggio Emilia, Italy. E-mail: serena. broccoli@ausl.re.it
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2013 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE:The authors have indicated they have nofinancial relationships relevant to this article to disclose.
FUNDING:No external funding.
APPENDIX Allocation Rules, Probability Weights, and Block Size According to Number of Eligible Children
Eligible Children Allocation Rule (Intervention:Control) Intervention Weight Control Weight Block Size
1 1:0 0 1 1
2 1:1 1 1 2
3 2:1 0.75 1.5 3
4 1:1 1 1 4
5 3:2 0.83 1.25 5
6 1:1 1 1 6
7 3:4 1.17 0.875 7
8 3:5 1.33 0.8 8
9 1:2 1.5 0.75 9
DOI: 10.1542/peds.2013-1738 originally published online October 21, 2013;
2013;132;e1236
Pediatrics
Paolo Giorgi Rossi
Mirco Pinotti, Gabriele Romani, Simone Storani, Marco Tamelli, Silvia Candela and
Ferrari, Stefania D'Angelo, Annarita Di Buono, Gino Montagna, Costantino Panza,
Anna Maria Davoli, Serena Broccoli, Laura Bonvicini, Alessandra Fabbri, Elena
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DOI: 10.1542/peds.2013-1738 originally published online October 21, 2013;
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Anna Maria Davoli, Serena Broccoli, Laura Bonvicini, Alessandra Fabbri, Elena
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