Chapter 10, Pediatric Cardiovascular Risk Reduction Guidelines, NHLBI

This section of the Guidelines provides recommendations to pediatric care providers on management of overweight and obesity in their patients. The section begins with background information on the current prevalence of overweight and obesity in childhood and the association between childhood overweight and obesity and cardiovascular (CV) risk factors. This is followed by a subsection addressing the identification of overweight and obesity and then individual subsections on the prevention and treatment of overweight and obesity in childhood, with the Expert Panel's summaries of the evidence reviews in each of these areas. The evidence review and the development process for the Guidelines are outlined in Section I. Introduction and are described in detail in the Appendix. Methodology. This evidence review combines a systematic review with an Expert Panel consensus process that incorporates and grades the quality of all relevant data based on preidentified criteria. Because of the large volume of included studies and the diverse nature of the evidence, the Expert Panel also provides a critical overview of the studies reviewed for each risk factor, highlighting those that in its judgment provide the most important information. Detailed information from each study has been extracted into the evidence tables, which will be available at http://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm. Each subsection ends with the conclusions of the review, grading of the evidence, and age-specific recommendations for the evaluation, prevention, and treatment of overweight and obesity in pediatric practice. Where evidence is inadequate, recommendations are a consensus of the Expert Panel. References are listed sequentially at the end of the section, with references from the evidence review identified by unique PubMed identifiers (PMID) in bold text. Additional references do not include the PMID number.

BACKGROUND

Dramatic increases in childhood overweight and obesity in the United States since 1980 are an important public health focus. Despite efforts over the past decade to prevent and control overweight and obesity, recent reports from the National Health and Nutrition Examination Survey (NHANES) show sustained high prevalence, with 17 percent of children and adolescents with a body mass index (BMI) above the 95th percentile for age and gender.^[1] Section 2. State of the Science: Cardiovascular Risk Factors and the Development of Atherosclerosis in Childhood reviews in detail the evidence that atherosclerosis in childhood and adolescence is associated with the presence and extent of individual risk factors, including obesity. To summarize, two major post mortem studies have demonstrated that the presence of obesity in childhood and adolescence is associated with increased evidence of atherosclerosis at autopsy, especially in males.^[2]^,^[3]^,^[4]^,^[5] Because of the strong association with elevated blood pressure, dyslipidemia, and insulin resistance (IR), obesity is even more powerfully correlated with atherosclerosis; this association has been shown for each of these risk factors in all of the major pediatric epidemiologic studies.^[6]^,^[7]^,^[8]^,^[9]^,^[10]^,^[11]^,^[12] Longitudinal studies have demonstrated tracking of elevated BMI and increased adiposity in childhood to the presence of obesity in adulthood.^[13]^,^[14]^,^[15]^,^[16] Improvement in weight status and decrease in body fatness have been shown to be associated with decreases in systolic and diastolic blood pressures (BPS),^[17]^,^[18]^,^[19]^,^[20] total cholesterol (TC), low-density lipoprotein cholesterol (LDL–C) and/or triglycerides (TG),^[18]^,^[20]^,^[21]^,^[22]^,^[23]^,^[24] IR,^[17]^,^[20]^,^[22]^,^[24] and inflammatory markers.^[20]^,^[25] Subclinical vascular changes indicative of atherosclerosis have been demonstrated in overweight and obese children;^[20]^,^[26]^,^[27]^,^[28] exercise and weight loss have been shown to result in significant improvement in these measures.^[20]^,^[28] Finally, epidemiologic studies have demonstrated that measures of obesity in childhood (greater skinfold thickness, higher BMI percentile) correlated significantly with greater evidence of arterial vascular abnormalities in adulthood, even after adjustment for adult contemporaneous risk factor status.^[29]^,^[30]^,^[31]^,^[32]^,^[33] Using childhood BMI z-scores and national death registry data, an epidemiologic study of 10,235 men and 4,318 women enrolled between 1930 and 1976 and followed up after age 25 years demonstrated that for each one unit increase in BMI z-score from ages 7–13 years in males and ages 10–13 years in girls, there was a significant increase in risk for a coronary heart disease event.^[34] Using an established computer-simulation, state-transition model of coronary heart disease (CHD in U.S. citizens older than age 35 years) and NHANES data for adolescents above the 95th percentile for weight in 2000, an analysis estimated that adolescent obesity will likely increase adult CHD by 5–16 percent over the next 25 years, with more than 100,000 excess cases of CHD attributable to obesity in childhood.^[35]

IDENTIFICATION OF OVERWEIGHT AND OBESITY IN CHILDREN AND ADOLESCENTS

To identify overweight and obesity in children living in the United States, BMI percentile distributions relative to gender and age on the Centers for Disease Control and Prevention (CDC) 2000 growth charts are now the preferred reference.^[36] The CDC growth charts were not developed as a health-related standard. Instead, the growth charts present percentiles of the BMI distribution derived from measurements taken during several NHANES surveys as points of reference. Although the charts were published in 2000, they include selected data from the 1963 to 1980 surveys and thus are not representative of the U.S. population in 2000. These BMI percentile growth charts provide the best reference data available for describing normal growth in U.S. children. They are, however, a screening tool and not an instrument for the diagnosis of overweight and obesity.

An expert committee jointly convened by the American Medical Association (AMA), the CDC, and the Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration, U.S. Department of Health and Human Services (HHS), recently recommended that BMI be used to assess weight-for-height relationships in children.^[37] This conclusion was reached because BMI can be easily calculated from height and weight, correlates strongly with direct measures of body fat (especially at higher BMI values), associates only weakly with height, and identifies individuals with the highest body fat correctly with acceptable accuracy, particularly above the 85th BMI percentile.^[38] Pediatric care providers need a feasible standard for identifying overweight and obesity in their patients, since parents recognize a child's overweight status in less than half of cases.^[39] The AMA/CDC/MCHB Expert Committee defined a BMI at or greater than the 95th percentile as obese and a BMI between the 85th and 94th percentiles as overweight; children in the latter BMI category have a great deal of variation with respect to prediction of future risk. The Expert Panel for these Guidelines concluded that BMI is a sufficient measure for screening children and adolescents to identify those who need evaluation for CV risk factors associated with body adiposity and that the scientific evidence linking elevated BMI to CV risk factors and morbidity is strong and well-supported.

The Expert Panel recommends that children and adolescents ages 2–18 years with a BMI at or greater than the 95th percentile be described as "obese" and identified as needing assessment for CV risk factors. For children with a BMI that falls between the 85th and 95th percentiles, the term "overweight" should be used, and the position of the child's BMI on the growth chart should be used to express concern regarding weight-for-height disproportion. It is very important to follow the pattern of growth over time, using these cut points to identify children who require more frequent followup and further assessment rather than to assign a diagnosis. Some may feel that "obese" is an unacceptable term for children and parents, so as with all health conditions, the practitioner is encouraged to use descriptive terminology that is appropriate for each child and family, with a thorough explanation and discussion. Each patient and family should be considered on an individual basis in deciding how best to convey the seriousness of this issue and to develop management plans.

OVERVIEW OF THE EVIDENCE ON PREVENTION OF OVERWEIGHT AND OBESITY: ROLE OF DIET OR COMBINED DIET AND PHYSICAL ACTIVITY INTERVENTIONS

Dietary recommendations for children and adolescents focus on promoting optimal health by including all foods and beverages necessary to provide required macronutrients and micronutrients and calories, consistent with HHS and U.S. Department of Agriculture 2010 Dietary Guidelines for Americans (2010 DGA).^[40] Prevention of overweight and obesity throughout childhood is a primary goal for the recommendations of these Guidelines and represents an important health objective for all children. The evidence review and the recommendations for nutrition and diet in all children are presented in Section 5. Nutrition and Diet. In this section, the focus of the evidence review is on studies that specifically addressed prevention of overweight and obesity in children and adolescents using primarily lifestyle interventions. Given the major overlap between the two dietary goals for children—promotion of CV health and prevention of obesity—the majority of the obesity prevention recommendations are the same as those developed for the promotion of CV health in all children.

The Expert Panel's evidence review for overweight and obesity included a large number of studies: 30 systematic reviews, 12 meta-analyses, 121 randomized controlled trials (RCTs), and 47 observational studies. There were five systematic reviews of intervention studies to prevent obesity, four of which were published between 2004 and 2006. The most recent was a rigorous review that selected only RCTs that included a control group and that directly addressed prevention of overweight and obesity in a normal population, with followup of at least 12 months and with obesity-specific outcome measures.^[41] The review included a total of 24 studies, and of these, all but 2 were school-based. The intervention was described for the 10 most recent studies and involved a combined dietary and physical activity intervention in 8 and a pure dietary intervention in 2; each of these is described below. The evidence review concluded that overall, the interventions described significantly reduced obesity measures, with 41 percent of studies reporting positive results.

The RCTs in the Expert Panel's evidence review for overweight and obesity were reviewed to identify a total of 17 studies that specifically addressed dietary intake in normal children within the context of overweight and obesity prevention. Many of these studies evaluated dietary interventions designed to address the prevention of overweight and obesity by lowering fat intake and increasing fruit and vegetable intake to meet the published nutritional goal of five servings per day of fruits and vegetables. Most were school-based and often were part of multicomponent programs designed to simultaneously change dietary intake and increase physical activity levels.^[42]^,^[43]^,^[44]^,^[45]^,^[46]^,^[47]^,^[48]^,^[49]^,^[50]^,^[51]^,^[52] The age groups addressed ranged from preschoolers to teenagers, and the study sizes from 213 to over 5,000 subjects. Measures of overweight and obesity varied and included weight, BMI, BMI percentile, and BMI z-score. Dietary intake was assessed by a variety of methods, including parental report, self-report, diet records, and direct observation of meals. Most studies were minimally successful in improving dietary quality, with small decreases in fat intake, small increases in fruit and vegetable intake, and small increases in physical activity; however, measures of obesity were rarely changed. As an example of this kind of study, a 2-year school-based health behavior intervention in children in grades 6–8 used sessions taught by classroom teachers focused on decreasing the consumption of high-fat foods, increasing fruit and vegetable intake, decreasing TV viewing, and increasing moderate and vigorous physical activity.^[46] There was no attempt to change caloric intake. Obesity was defined as a composite indicator based on BMI and triceps skinfold thickness greater than or equal to age- and gender-specific 85th percentiles. After 2 years, fruit and vegetable consumption increased, and TV viewing time decreased in boys and girls. There was no change in time spent in moderate and vigorous physical activity, the primary outcome of the trial. Prevalence of obesity decreased among girls but not boys.

Another example is the Child and Adolescent Trial for Cardiovascular Health (CATCH), the largest school-based study ever funded in the United States, taking place in 96 schools.^[51] This multicomponent school CV health promotion intervention for middle-school children resulted in improvement in children's diets, with significantly lower saturated fat intakes and significantly more vigorous physical activity by children in the intervention schools, findings that were sustained for 3 years after the end of the trial.^[52] CATCH intervention goals were not focused on obesity, and there were no differences in BMI during the original study or at late followup. The Pathways school RCT in American Indian schoolchildren used similar approaches to CATCH in changing the school diet and physical activity environments, in addition to teaching lifestyle approaches through curricula. The Pathways trial focused on obesity prevention; however, there were no significant differences in obesity measures between the randomized groups, although measures of diet and physical activity did improve.^[53]

An example of a primary dietary intervention study is the Special Turku Coronary Risk Factor Intervention Project (STRIP), which randomized 1,062 Finnish infants to a conventional diet or a low-saturated fat diet at age 7 months.^[54] The intervention families received individualized counseling biannually by a dietitian who focused on lowering saturated fat in the diet and a physician who consistently recommended increased physical activity with no specific activity intervention. Since the study began in 1990, the children have been evaluated at least annually. Review of growth data indicates that there have been consistently fewer overweight girls in the intervention group beginning at age 2 years. At age 10 years, 10.2 percent of girls in the intervention group were overweight (defined as 20 percent above weight for height of average Finnish children) compared with 18.8 percent of controls (P = 0.04); there was no difference in overweight prevalence between groups among boys. There was no significant difference between intervention and control groups in weight for height or obesity (40 percent above average weight for height) at any single age. At 9-year followup, both male and female children in the intervention group reported consuming less total fat and saturated fat and had higher insulin sensitivity than did controls.^[55]^,^[56] A detailed evaluation of macronutrient and micronutrient intakes, linear growth, and neurologic status has identified no adverse effects from the intervention.

To evaluate the relationship between calcium intake and body fat in the prevention of obesity, an RCT of calcium supplementation and physical activity was conducted in preschool children. Analysis of body composition and calcium intake showed no association for the entire group. Among children in the lowest tertile of calcium intake, fat mass gain was lower in the calcium group, but this was not correlated with total calcium intake.^[57]

Observational studies described in detail in Section 5. Nutrition and Diet have linked increased consumption of sugar-sweetened beverages with the development of overweight and obesity. One RCT assigned adolescents with a BMI above the 25th percentile for age and gender who regularly consumed at least one sugar-sweetened beverage/day to an intervention in which noncaloric beverages were delivered to the home free of charge for 25 weeks.^[58] Consumption of sugar-sweetened beverages was reduced dramatically, by 82 percent in the intervention group, with no change in controls. BMI increased in both groups; although the increase was less in the intervention group than in the control group, the difference between groups was not significant. However, among subjects in the highest tertile for BMI at baseline (above the 75th percentile), reduction of sugar-sweetened beverages was accompanied by a significant decrease in BMI compared with an increase in BMI in controls. This pilot study suggests that reducing sugar-sweetened beverage intake may have a beneficial effect on body weight in overweight and obese adolescents. Another study was a cluster RCT testing the reduced intake of carbonated drinks on obesity in six primary schools in England; carbonated drinks were reduced by a 0.7 net servings/day along with a modest decrease in overweight/obese children.^[59]

Innovative methods for teaching nutrition and changing diet to prevent overweight and obesity have been explored. A computer game-based intervention with overweight and obesity as a secondary outcome was associated with improved nutritional knowledge and better food choices than a conventional curriculum among students in the last three grades of primary school.^[43] A 10-session multimedia game designed to increase preference for fruits and vegetables was successful among fourth-grade students in increasing their fruit and vegetable consumption over a 5-week intervention.^[60]

CONCLUSIONS OF THE EVIDENCE REVIEW ON PREVENTION OF OVERWEIGHT AND OBESITY WITH DIET OR COMBINED DIET AND PHYSICAL ACTIVITY INTERVENTIONS

The Expert Panel concluded that there is good evidence that the dietary behavior of children can be safely improved with interventions that result in lower saturated fat intake, reduced intake of sugar-sweetened beverages, and increased consumption of fruits and vegetables. None of these studies included any intervention to change calorie intake. In a small number of studies, the changes described are associated with significantly lower BMI or BMI percentile on followup. Most studies also had specific interventions aimed at changing physical activity behaviors, so it is difficult to separate benefits related to diet change alone. Although calorie balance is generally seen as a key issue for weight control, intervention studies addressing both diet and physical activity had mixed results, perhaps because most offered relatively weak interventions at the community level rather than targeting individual, at-risk youths. No evidence was identified that diets that address lowering saturated fat intake, reducing intake of sugar-sweetened beverages, and increasing consumption of fruits and vegetables are harmful.

For pediatric patients with a BMI below the 85th percentile for age and gender, the recommendations in these Guidelines for nutrition and diet for reducing CV risk for all children, which build on the 2010 DGA for the general public (CHILD 1, Section V. Nutrition and Diet), specifically address optimizing the diet in each of these areas, as well as increasing intake of whole grains and matching energy intake to growth and energy expenditure with monitoring of BMI and dietary intake over time.⁴⁰ No additional dietary recommendations to prevent obesity are indicated based on this evidence review. As described above, it is very important to follow the pattern of growth over time to identify children who require more frequent followup, further assessment, and intervention.

OVERVIEW OF THE EVIDENCE ON PREVENTION OF OVERWEIGHT AND OBESITY: ROLE OF PHYSICAL ACTIVITY

There is strong evidence for the beneficial effects of physical activity and limiting sedentary time on the overall health of children and adolescents.^[61] ^[62] Section 6. Physical Activity reviewed the evidence on the benefits of physical activity and limited sedentary time on overall CV health, including a decrease in BMI, especially if subjects are overweight or obese. The recommendations for activity for all children in these Guidelines address both the limitation of sedentary activity and the prescription of daily physical activity. A recent evidence-based review of physical activity included 850 studies in children and recommended at least 60 minutes of moderate to vigorous physical activity daily to achieve beneficial effects on health,⁶¹ The authors concluded that such a program would have little influence on BMI in normal-weight children.

From the evidence review for these Guidelines, studies were identified that addressed obesity prevention through a pure physical activity intervention to increase physical activity and/or decrease sedentary time. These are not common, with one systematic review and eight RCTs identified in which a physical activity intervention was tested to prevent obesity. A systematic review by The Cochrane Collaboration addressed prevention of overweight and obesity and selected 22 studies published between 1990 and 2005 for inclusion.^[63] Two of 10 long-term studies lasting at least 12 months and 4 of 12 short-term studies focused on physical activity alone, and each is included in the RCT review below. Overall, the Cochrane reviewers concluded that physical activity "interventions employed to date have, largely, not impacted weight status of children to any degree." The Cochrane reviewers noted that, as a group, the studies have been underpowered and/or poorly designed, with interventions often set for short-term impact.

From the RCTs in the evidence review for these Guidelines, a 6-month, classroom-based trial in third- and fourth-grade students was effective in decreasing sedentary activity (TV and video use), with associated significant relative decreases in BMI, triceps skin folds, waist circumference, and waist-to-hip ratio in the intervention group compared with the control group.^[64] A school-based trial in fourth-grade students compared three groups: three 30-minute physical activity classes/week taught by an exercise specialist, three classes taught by a teacher, and no activity classes.^[65] After 3 school years, there was no significant improvement in BMI or body fat measures, but interpretation of results was complicated by differences between the groups at baseline. In a small group of nonobese sedentary adolescent males, a 5-week prospective trial of endurance training was associated with decreased thigh fat but no change in BMI or intra-abdominal fat.^[66] In nonobese African American girls, a 12-week pilot intervention with an afterschool dance class and education to reduce sedentary activity at home was associated with a significant decrease in home TV use and fewer meals in front of the TV, increased physical activity, decreased BMI, and decreased waist circumference; the latter results were not significant, but the study was not powered for these outcomes.^[67] A year-long enhanced physical activity program in nursery schools in Scotland had no effect on BMI or measures of physical activity and sedentary behavior at 6 and 12 months.^[68]

Gender differences in response to interventions were reported in two school-based trials. After an intervention that combined education and activity for inner-city high school students, health knowledge was improved in males and females, but eating habits and fitness and cholesterol levels were significantly improved only in females, with no change in males; neither males nor females had any change in BMI.^[69] Among second-grade American Indian children enrolled in a physical activity intervention, boys were seen to be more active at baseline and followup.^[70] Activity levels were increased among children in the intervention schools compared with controls, but there was no difference in BMI or percentage of body fat.

CONCLUSIONS OF THE EVIDENCE REVIEW ON PREVENTION OF OVERWEIGHT AND OBESITY WITH PHYSICAL ACTIVITY

The RCTs described above have evaluated the effect of interventions that addressed only physical activity and/or sedentary behavior on prevention of overweight and obesity. In a small number of these, the intervention was effective. Notably, these successful interventions often addressed reduction in sedentary behavior rather than attempts to increase physical activity. In the majority of studies, there was no significant difference in any measure of body size, including BMI, BMI percentile, or percentage of body fat. Sample sizes were often small, and followup was often short, frequently less than 6 months. The results of one study suggested that gender-specific programs may be more successful in changing physical activity behavior. Overall, the Expert Panel concluded that, based on the evidence review, increasing physical activity in isolation is of little benefit in preventing obesity. By contrast, the review suggests that reducing sedentary behavior may be beneficial in preventing the development of obesity. The physical activity recommendations in these Guidelines specifically address the CV health benefits of limiting sedentary behavior and increasing physical activity in all children (Section VI. Physical Activity). No additional specific recommendations addressing activity in preventing obesity beyond those developed for all children are indicated based on this evidence review.

OVERVIEW OF THE EVIDENCE ON CHILDREN AT INCREASED RISK FOR OVERWEIGHT AND OBESITY

Certain populations of children who are of normal weight are at risk for developing overweight and obesity as they grow older. Observational studies have identified risk factors that put these children at greater risk; however, research is lacking regarding an appropriate intervention. Despite that fact, epidemiologic associations suggest that primary care providers should be alert to increasing BMI trends and excessive weight gain beyond what is anticipated for height increase or pubertal change when dealing with these children and should consider intervention before the child becomes overweight.

From the evidence review for these Guidelines, observational studies have identified sample populations that are at special risk for obesity as follows:

No RCTs that specifically address these populations were identified. Despite this absence of RCT evidence, the Expert Panel believes that lifestyle recommendations addressing energy balance—diet and physical activity—with a goal of prevention of excess weight gain are needed for normal-weight children with characteristics consistent with these special risks for the development of overweight and obesity. The diet and activity recommendations proposed for all children in these Guidelines should be vigorously reinforced in these children. In any child, the development of a BMI between the 85th and 95th percentiles should be taken as a sign that increased attention to diet and activity, as well as BMI-specific followup, is indicated.

OVERVIEW OF THE EVIDENCE ON TREATMENT OF OBESITY

In children who are already obese, the primary goal of obesity treatment is to improve weight-for-height disproportion through weight loss in older children or through weight maintenance during linear growth through adoption of a healthier lifestyle in younger children. From this evidence review, many studies measuring intermediate variables have shown a significant decrease in CV risk factors with an improvement in weight and/or decrease in body fatness: decreases in systolic and diastolic BPs;^[17]^,^[18]^,^[19]^,^[20]^,^[77]^,^[78] decreases in TC, LDL–C, and/or TG^[18]^,^[19]^,^[20]^,^[21]^,^[22] decrease in IR;^[17]^,^[19]^,^[20]^,^[22]^,^[23]^,^[24] decrease in inflammatory markers;^[25] and improvement in subclinical measures of atherosclerosis.^[20]^,^[28]^,^[79] If weight improvements are sustained, these studies suggest that the improved weight profile should be associated with improved overall health and CV risk, reduced incidence of type 2 diabetes mellitus (T2DM), and other problems known to be associated with obesity in childhood.

The evidence review for overweight and obesity for these Guidelines identified 5 systematic reviews, 2 meta-analyses, and 69 RCTs addressing the treatment of obesity. Of these, a major systematic review from the U.S. Preventive Services Task Force (USPSTF) in 2005 considered all treatment intervention trials applicable to primary care settings published since 1985 in Western industrialized nations.^[80] Of 23 identified studies, the majority involved short-term, behavioral counseling interventions in small numbers of primarily White school-aged children. At followup, mean BMI percentiles decreased from above the 95th percentile at baseline to between the 90th and 95th percentiles at 1-year followup; no long-term followup results were available. Six studies in the USPSTF review involved adolescents, as did an additional review of 17 studies confined to adolescents.^[81] Only half of the interventions were associated with any mean change in BMI at short-term followup. No long-term followup results were available. In all adolescent studies, high dropout rates, as high as 45 percent, complicate the interpretation of results. No adverse effects on eating behaviors, eating disorder symptoms, or weight dissatisfaction were reported, but these results often were not specifically provided. Both published reviews concluded that the evidence that behavioral counseling interventions are effective treatment for obese children and adolescents is fair to poor because of small, short-term studies with limited generalizability.

By contrast, a 2008 systematic review from the Agency for Healthcare Research and Quality evaluated RCTs of weight interventions in obese and overweight children and adolescents released between 2005 and 2007; the review concluded that medium- to high-intensity (defined as meeting for at least 25 hours over 6 months) behavioral management programs were effective in achieving small to moderate weight loss that was sustained for up to 12 months after the end of treatment.^[82] The majority of studies took place in specialized centers for obesity research, with only rare studies in clinical practice settings.

A 2007 meta-analysis quantitatively evaluated the efficacy of RCTs that used lifestyle interventions—defined as any combination of diet, physical activity, and/or behavioral treatment—published before August 2005. Lifestyle interventions were compared with no-treatment control groups or information/education-only controls. Effect sizes were calculated from the means and standard deviations of the change scores of the weight loss measure (percentage overweight, BMI z-score, BMI, or weight) from the beginning of treatment to the end of treatment and/or followup; only one weight measure was included for each study. Compared with both kinds of controls, there was a significant effect size at the end of treatment and at followup.^[83]

A majority of RCTs in the evidence review for these Guidelines tested a hypocaloric diet and an increase in physical activity with behavior change counseling to support these changes. Twenty-one RCTs described this type of combined intervention, and obesity measures included percentage overweight, weight, relative weight, BMI percentile, BMI z-score, body fat percentile, and/or waist circumference. Thirteen of 21 trials reported a significant decrease in at least one of these measures on short-term followup, when intervention and control groups were compared.^[84]^,^[85]^,^[86]^,^[87]^,^[88]^,^[89]^,^[90]^,^[91]^,^[92]^,^[93]^,^[94]^,^[95]^,^[96] Two of these studies were initiated in primary care settings, and the remainder occurred in research clinics. Of note, in obese adolescents, inclusion of peers in a cognitive-behavioral diet and activity intervention was successful in achieving significant weight loss sustained at 10-month followup.^[93] Ten-year followup of obese children (ages 6–12 years at enrollment) documented sustained improvement in weight-for-height measures of family-based interventions based on training children and parents in optimal food choices in a research setting.^[88]^,^[94] This is the first evidence that weight regulation in children can be achieved and maintained over extended periods from childhood through adolescence. Change in physical activity in addition to dietary change was significantly associated with reduced obesity in this report. Another significant variable from this study that has been replicated by others was the importance of a treatment focus on parents in children this age.^[92]^,^[94]^,^[95]^,^[96] Another RCT tested an intervention designed for weight maintenance after an active weight loss treatment program in 204 healthy children ages 7–12 years with elevated BMI; the trial found that maintenance-targeted treatment improved weight loss short term compared with no maintenance treatment, but effects were not significant at 2 years.^[97]

There were 21 studies in this evidence review that specifically evaluated an exercise intervention alone or in combination with dietary change, either an increase in physical activity, a decrease in sedentary activity, or a combination. Of these, nine involved a pure physical activity intervention with no recommended diet change versus no intervention.^[79]^,^[98],^[99],^[100],^[101],^[102],^[103],^[104],^[105],^[106],^[107] Most showed a decrease in body fat and/or an increase in fat-free mass in the exercise group, but only one showed a decrease in weight and BMI.^[104] In this study, points scored with activity allowed children to earn TV time, and weight changes were accompanied by a significant increase in moderate to vigorous activity and a decrease in sedentary activity. Exercise alone was shown to decrease IR^[102]^,^[105] and improve subclinical measures of atherosclerosis even without weight change.^[79]^,^[98]^,^[100] In the remainder of these studies, an activity intervention and diet change were compared with diet alone.^[17]^,^[18]^,^[20]^,^[23]^,^[108]^,^[109]^,^[110]^,^[111]^,^[112]^,^[113]^,^[114] The combination of dietary change and a specific exercise intervention was universally more effective at achieving decreases in weight and BMI, as well as decreases in body fat when compared with an isolated dietary intervention.

Seven studies that met the criteria for inclusion in the Expert Panel evidence review evaluated specific dietary interventions. Three studies compared a low glycemic-load diet to a low-fat diet; two of these were in young adults (ages 18–40 years), and one was in adolescents.^[78]^,^[115]^,^[116] In all three trials, both diet groups lost weight, but loss was greater in the low-glycemic index group. One study compared a low-carbohydrate diet to a low-fat diet over 12 weeks in 39 adolescents, with greater BMI decrease in the low-carbohydrate group.^[19] In two studies, a fiber supplement was added to a hypocaloric diet with no difference in outcomes when compared with diet alone.^[117]^,^[118] Finally, a short-term, protein-sparing modified fast was compared with a hypocaloric balanced diet in a very small group of children ages 7–15 years, with marked decrease in weight and BMI at 10-week followup for the protein-sparing, modified-fast diet group.^[119] Results were sustained at 4.5-months followup but not at 10.5 months when loss to followup was significant. In addition, in this study, the two groups were not comparable at baseline.

Addition of medication to behavioral lifestyle counseling for diet and exercise was investigated in a series of RCTs in pediatric populations, which are detailed below. Three small metformin trials (N = 24–29) enrolled male and female adolescents with severe elevation of BMI (mean greater than 35 kg/m²) and hyperinsulinism without diabetes or with impaired glucose tolerance. Each study used a different metformin dose (500 mg–1 g bid). Treatment duration was 6 months in two studies and 8 weeks in the third. All three reported statistically significant decreases in weight and/or BMI and fasting insulin with metformin compared to placebo. In the two studies that included lipids as a secondary outcome, the effect was improvement in one and no effect in the other.^[24]^,^[120]^,^[121]

For adolescents older than age 12 years, adding orlistat, which causes fat malabsorption through inhibition of enteric lipase, to a comprehensive lifestyle weight loss program was investigated in four trials. A large multicenter RCT enrolled 539 obese 12- to 16-year-olds, excluding those with BMI 44 kg/m²or higher, diabetes requiring medication, and other medical and psychiatric conditions. After 52 weeks, 65 percent of participants were retained; there was significantly greater lowering of all obesity measures in the orlistat group compared with controls.^[122] In a smaller trial, use of orlistat was associated with a significantly greater decrease in BMI and body weight from baseline after 1 year of treatment; absolute BMI was also lower in the orlistat treatment group, but this difference was not significant.^[123] In a small 6-month trial, orlistat was not associated with a significant difference in any obesity measure.^[124] In a small study designed to investigate mineral balance in adolescent obese volunteers, there was no difference in any of 6 selected microminerals or macrominerals after 21 days of orlistat treatment.^[125] In all of these studies, there was a high reported rate of gastrointestinal symptoms with orlistat involving up to 32 percent of subjects.

In adolescents (ages 12–16 years) with severe elevation of BMI (32–44 kg/m²), the addition of sibutramine, a serotonin reuptake inhibitor, to a comprehensive lifestyle weight loss program significantly improved weight loss, BMI, and measures of metabolic risk at 6- to 12-month followup in three RCTs.²²^,^[126]^,^[127]^,^[128] The trials excluded subjects with comorbidities, such as elevated BP, diabetes mellitus, CV disease, and/or elevated heart rate. A large RCT involved 498 participants, ages 12–16 years. After 1 year, 76 percent of sibutramine subjects and 62 percent of placebo subjects completed the study. The sibutramine group had significantly greater decreases in BMI and body weight.^[22] Potential CV side effects were investigated in a separate analysis of this trial.^[126] Tachycardia was significantly more common in the sibutramine group but did not lead to increased drug withdrawal. Medication was stopped for BP in 1 percent of subjects in the sibutramine group versus none in the placebo group. After 1 year, systolic and diastolic BPs and heart rates were decreased from baseline in both intervention and control subjects, with no significant difference between groups.^[22]^,^[126] In one small trial, 9 of 43 subjects on sibutramine had medication decreased or stopped for an increase in BP, heart rate, or both, above a prespecified threshold.¹²⁷ A third small trial (N = 46) did not report stopping sibutramine for BP or heart rate in any subject.^[128] Sibutramine was withdrawn from the U.S. market on October 8, 2010. This withdrawal was due to a 16-percent increase in risk of major CV adverse events demonstrated in the Sibutramine Cardiovascular Outcomes trial in adults: a composite of nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest and CV death.^[129]

A single study of hospitalized adolescents with severe elevation of BMI (all greater than 35 kg/m²) treated with fenfluramine showed no advantage over diet alone.^[130]

Recent studies have examined adolescents receiving bariatric surgery.^[131]^,^[132] One examined nationwide use of bariatric surgery in adults and adolescents, concluding that bariatric surgery in adolescents is uncommon compared with use in adults. There were 771 bariatric procedures performed in the United States in 2003, triple the number performed in 2000; 12 percent of adolescents receiving the surgery had comorbid conditions.^[131] The other study was a case series (N = 38) examining outcomes from bariatric surgery in adolescents; mean preoperative BMI was 60 +/- 8 kg/m² compared with 40 +/- 8 kg/m² at a mean followup of 10 months. The study found significant improvements in CV measures on postoperative followup.^[132] Generally, bariatric procedures have been performed in academic centers as part of research protocols. There are no long-term data on followup after bariatric surgery in adolescents.

CONCLUSIONS AND GRADING OF THE EVIDENCE REVIEW ON TREATMENT OF OBESITY

Table 10–1. Evidence-Based Recommendations for Management of Child and Adolescent Patients With Overweight and Obesity

Grades reflect the findings of the evidence review.
Recommendation levels reflect the consensus opinion of the Expert Panel.

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10. Overweight and Obesity

INTRODUCTION