Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial.

CONTEXT: Pediatric obesity has escalated to epidemic proportions, leading to an array of comorbidities, including type 2 diabetes in youth. Since most overweight children become overweight adults, this chronic condition results in serious metabolic complications by early adulthood. To curtail this major health issue, effective pediatric interventions are essential. OBJECTIVE: To compare effects of a weight management program, Bright Bodies, on adiposity and metabolic complications of overweight children with a control group. DESIGN: One-year randomized controlled trial conducted May 2002-September 2005. SETTING: Recruitment and follow-up conducted at Yale Pediatric Obesity Clinic in New Haven, Conn, and intervention at nearby school. PARTICIPANTS: Random sample of 209 overweight children (body mass index [BMI] >95th percentile for age and sex), ages 8 to 16 years of mixed ethnic groups were recruited. A total of 135 participants (60%) completed 6 months of study, 119 (53%) completed 12 months. INTERVENTION: Participants were randomly assigned to either a control or weight management group. The control group (n = 69) received traditional clinical weight management counseling every 6 months, and the weight management group (n = 105) received an intensive family-based program including exercise, nutrition, and behavior modification. Intervention occurred biweekly the first 6 months, bimonthly thereafter. The second randomization within the weight management group assigned participants (n = 35) to a structured meal plan approach (dieting), but this arm of the study was discontinued while enrollment was ongoing due to a high dropout rate. MAIN OUTCOME MEASURES: Change in weight, BMI, body fat, and homeostasis model assessment of insulin resistance (HOMA-IR) at 6 and 12 months. RESULTS: Six-month improvements were sustained at 12 months in weight management vs control, including changes in the following (mean [95% confidence interval]): weight (+0.3 kg [-1.4 to 2.0] vs +7.7 kg [5.3 to 10.0]); BMI (-1.7 [-2.3 to -1.1] vs +1.6 [0.8 to 2.3]); body fat (-3.7 kg [-5.4 to -2.1] vs +5.5 kg [3.2 to 7.8]); and HOMA-IR (-1.52 [-1.93 to -1.01] vs +0.90 [-0.07 to 2.05]). CONCLUSION: The Bright Bodies weight management program had beneficial effects on body composition and insulin resistance in overweight children that were sustained up to 12 months. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00409422.

Anthropometric and psychosocial changes in obese adolescents enrolled in a Weight Management Program.

OBJECTIVE: To determine short- and long-term effects of the Bright Bodies Weight Management Program on obese adolescents and to further observe if a diet or nondiet approach is more successful. DESIGN: Twenty-five obese adolescents completed a 1-year, comprehensive weight-management program and returned for a 2-year follow-up. Adolescents were 11 to 16 years old (17 female, eight male) with mixed ethnic backgrounds. Although the program emphasizes a nondiet approach, eight children requested a structured meal plan (diet approach), while 17 were taught to make better food choices (nondiet approach). Body mass index (BMI) z score, body fat percent, and self-concept were measured at 0, 1, and 2 years. Outcomes were analyzed for the entire group and by diet method groups. STATISTICAL ANALYSIS: Changes in outcome variables were evaluated using covariance pattern models for repeated measures. RESULTS: At 1 year, the entire group (N=25) demonstrated a decrease in BMI z score (P <.001) and body fat percent (P <.001), while self-concept scores increased (P <.001). At 2 years, the decrease in BMI z score was still significant (P =.004) and body fat percent and self-concept scores remained improved, although not significant compared to baseline (P =.15 and P =.10, respectively). When comparing dietary approaches, the dieting group (n=8) tended to show favorable results short-term for BMI z score at year 1 (P =.11), but by year 2, the nondieting group (n=17) further improved BMI z score (P =.006), while the dieting group reverted toward baseline. CONCLUSIONS: The Bright Bodies Weight Management Program was successful at decreasing BMI z scores both short and long term. In a separate analysis, dieting showed more superior short-term results, but a nondiet approach demonstrated improved long-term results.

Effectiveness of a spanish language clinic for Hispanic youth with type 1 diabetes.

OBJECTIVE: A pilot study was undertaken to determine whether establishment of a Spanish Language Diabetes Clinic (SLDC) for Spanish-speaking families conducted by a team of Spanish-speaking, Hispanic and nonHispanic clinicians provides a means to improve control of type 1 diabetes (T1D). METHODS: The first 21 Hispanic pediatric patients with T1D who enrolled in the SLDC were matched to 21 Hispanic patients treated in the English Language Diabetes Clinic (ELDC) based on age and duration of diabetes. The two groups did not differ significantly with respect to gender, body mass index (BMI), or glycated hemoglobin (HbA1c). Patients in both groups were followed for 12 months. RESULTS: The mean (± standard deviation) baseline glycated hemoglobin (HbA1c) level in the SLDC group (8.4 ± 1.0%) was similar to that in the ELDC group (8.6 ± 1.4%, P = .83). HbA1c levels fell by 0.5 ± 1.0% (P = .01) during the year following enrollment in the SLDC but did not change significantly from baseline during the year of follow-up in the ELDC group (decrease of 0.2 ± 0.9%, P = .1). At the start of the study, only 5 patients (23%) in the SLDC group and 7 patients (33%) in the ELDC group met the ≤7.5% target HbA1c level. After 1 year, 10 of the SLDC patients (48%) and 4 of ELDC patients (19%) had HbA1c levels ≤7.5% (P = .01). CONCLUSIONS: Our preliminary findings support the hypothesis that overcoming language barriers by the establishment of a SLDC can be an effective means of improving metabolic control in youth with T1D in Hispanic families with limited English language skills.

Utility of hemoglobin A(1c) for diagnosing prediabetes and diabetes in obese children and adolescents.

OBJECTIVE: Hemoglobin A(1c) (A1C) has emerged as a recommended diagnostic tool for identifying diabetes and subjects at risk for the disease. This recommendation is based on data in adults showing the relationship between A1C with future development of diabetes and microvascular complications. However, studies in the pediatric population are lacking. RESEARCH DESIGN AND METHODS: We studied a multiethnic cohort of 1,156 obese children and adolescents without a diagnosis of diabetes (male, 40%/female, 60%). All subjects underwent an oral glucose tolerance test (OGTT) and A1C measurement. These tests were repeated after a follow-up time of ∼2 years in 218 subjects. RESULTS: At baseline, subjects were stratified according to A1C categories: 77% with normal glucose tolerance (A1C <5.7%), 21% at risk for diabetes (A1C 5.7-6.4%), and 1% with diabetes (A1C >6.5%). In the at risk for diabetes category, 47% were classified with prediabetes or diabetes, and in the diabetes category, 62% were classified with type 2 diabetes by the OGTT. The area under the curve receiver operating characteristic for A1C was 0.81 (95% CI 0.70-0.92). The threshold for identifying type 2 diabetes was 5.8%, with 78% specificity and 68% sensitivity. In the subgroup with repeated measures, a multivariate analysis showed that the strongest predictors of 2-h glucose at follow-up were baseline A1C and 2-h glucose, independently of age, ethnicity, sex, fasting glucose, and follow-up time. CONCLUSIONS: The American Diabetes Association suggested that an A1C of 6.5% underestimates the prevalence of prediabetes and diabetes in obese children and adolescents. Given the low sensitivity and specificity, the use of A1C by itself represents a poor diagnostic tool for prediabetes and type 2 diabetes in obese children and adolescents.

Insulin pump therapy in pediatrics: a therapeutic alternative to safely lower HbA1c levels across all age groups.

OBJECTIVE: To examine the efficacy and safety of using continuous subcutaneous insulin infusion (CSII) therapy in a large group of patients 18 months to 18 yr from a single pediatric diabetes program. RESEARCH DESIGN AND METHODS: All patients < or = 18 yr of age starting on CSII from 1 January 1997 to 31 March 2000 at the Yale Children's Diabetes Program were included. Clinical data were collected prospectively before and during pump treatment. HbA1c was the primary efficacy outcome and rates of diabetes-related adverse events were the primary safety measures. RESULTS: One hundred and sixty-one children ranging in age from 18 months to 18 yr received CSII for an average of 32 +/- 9 months when data collection was closed on 31 October 2001, including 26 preschoolers (< 7 yr), 76 school-agers (7-11 yr) and 59 adolescents (12-18 yr). Mean HbA1c levels were 7.1% in the preschoolers, 7.8% in the school-agers and 8.1% in the adolescents prior to the start of CSII. There was a significant and consistent reduction in mean HbA1c levels after 12 months of CSII (to 6.5% in preschoolers, 7.3% in school-agers and 7.4% in adolescents, p < 0.02 vs. prepump) that was maintained at the most recent visit. Improved diabetes control was achieved with CSII without increasing daily insulin doses and in association with a decrease in the frequency of severe hypoglycemic events (p < 0.05 vs. prepump, all three age groups combined). CONCLUSIONS: CSII is an effective alternative to injection therapy in a large pediatric diabetes clinic setting. Even very young patients can utilize CSII to safely lower HbA1c levels.