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result(s) for
"Pediatric Obesity - therapy"
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Once-Weekly Semaglutide in Adolescents with Obesity
by
Barrientos-Pérez, Margarita
,
Arslanian, Silva
,
Weghuber, Daniel
in
Administration, Cutaneous
,
Adolescence
,
Adolescent
2022
A once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is used to treat obesity in adults, but assessment of the drug in adolescents has been lacking.
In this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (12 to <18 years of age) with obesity (a body-mass index [BMI] in the 95th percentile or higher) or with overweight (a BMI in the 85th percentile or higher) and at least one weight-related coexisting condition. Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary end point was the percentage change in BMI from baseline to week 68; the secondary confirmatory end point was weight loss of at least 5% at week 68.
A total of 201 participants underwent randomization, and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points; 95% confidence interval [CI], -20.3 to -13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, lipids [except high-density lipoprotein cholesterol], and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.
Among adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone. (Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189.).
Journal Article
A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity
by
Barrientos-Perez, Margarita
,
Prabhu, Nandana
,
Hale, Paula M
in
Adolescence
,
Adolescent
,
Adolescents
2020
Adolescents with obesity and a poor response to lifestyle therapy alone were randomly assigned to receive either liraglutide or placebo subcutaneously once daily, in addition to lifestyle therapy. The use of liraglutide led to a significantly greater reduction in the standard-deviation score for the body-mass index than placebo.
Journal Article
Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial
by
Barrientos-Pérez, Margarita
,
Jalaludin, Muhammad Yazid
,
Sahu, Kushal
in
Adolescent Medicine
,
Adverse events
,
Anti-Obesity Agents - administration & dosage
2025
Obesity often develops in childhood. In children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions induced a greater mean change in BMI than lifestyle interventions alone.
Journal Article
Effect of a Low-Glycemic Index Nutritional Intervention on Body Weight and Selected Cardiometabolic Parameters in Children and Adolescents with Excess Body Weight and Dyslipidemia
2024
Excess body weight in pediatric patients and the resulting dyslipidemia, if left untreated, are a serious risk factor for cardiovascular disease in young adults. Despite this, there is still no effective and validated nutritional strategy for the treatment of overweight/obesity and comorbid dyslipidemia in children and adolescents. A low-glycemic index (LGI) diet may be recommended, but evidence for its effectiveness in the pediatric population is limited. The aim of this study was to evaluate the effectiveness of nutritional intervention in children and adolescents with excess body weight and dyslipidemia. The study was conducted in patients aged 8–16 with overweight or obesity and lipid disorders (n = 64), of which 40 participants who completed the entire 8-week study were included in the analysis. Patients were randomly selected and allocated to one of the two dietary groups: the LGI diet or the standard therapy (ST) diet. Both diets were based on the principal recommendation of Cardiovascular Health Integrated Lifestyle Diet-2 (CHILD-2). This study showed that both LGI and ST diets were equally beneficial in reducing body weight, body fat, blood pressure, total cholesterol (TC), and triglyceride (TG) levels. The LGI diet, compared to the ST diet, was less effective in reducing blood TG levels but more effective in reducing diastolic blood pressure (DBP). Therefore, the choice of the type of diet in the treatment of children and adolescents with excess body weight and dyslipidemia may be individual. However, it should be based on the recommendation of CHILD-2. Further long-term, larger-scale studies are needed.
Journal Article
The GReat-Child™ Trial: A Quasi-Experimental Intervention on Whole Grains with Healthy Balanced Diet to Manage Childhood Obesity in Kuala Lumpur, Malaysia
2018
Background: The GReat-Child Trial was a quasi-experimental intervention that has emphasized whole grain as a strategy to manage childhood obesity. Methods: Two schools in Kuala Lumpur with similar demographic characteristics were assigned as intervention (IG) and control (CG). Eligibility criteria were overweight/obese children aged 9 to 11 years who had no serious co-morbidity. Children who reported consuming wholegrain foods in their 3-day diet-recall during screening were excluded. A total of 63 children (31 IG; 32 CG) completed the entire intervention program. The IG children underwent six 30-min nutrition education lessons and had school delivery of wholegrain food on a daily basis over a 12-week period. Parents of IG children attended 1-h individual diet counseling. Anthropometric outcomes including BMI-for-age z-score (BAZ), body fat percentage and waist circumference were measured at baseline [T0], post-intervention [T1] (3rd month) and follow-up [T2] (9th month). Results: IG showed significantly lower BAZ (weighted difference: −0.12; 95% CI: −0.21, −0.03; p = 0.009), body fat percentage (weighted difference: −2.6%; 95% CI: −3.7, −1.5; p < 0.001) and waist circumference (weighted difference: −2.4 cm; 95% CI: −3.8, −1.0; p = 0.001) compared to CG. IG reported significantly lower body fat percentage (weighted difference: −3.4%; 95% CI: 1.8, 5.0; p < 0.001) and waist circumference (weighted difference: −2.1 cm; 95% CI: −3.7, −0.5; p = 0.014) at T1 compared to T0. Conclusions: The GReat-Child Trial made a positive impact in managing childhood obesity. It can be incorporated into childhood obesity intervention programs that are being implemented by the policy makers.
Journal Article
Association of dairy intake with weight change in adolescents undergoing obesity treatment
2019
The role of dairy products in obesity treatment for adolescents is unclear. The study purpose was to assess the association between dairy intake and changes in BMI z-score (zBMI) during adolescent obesity treatment.
Observational study nested within a randomized control trial. Linear mixed-effects regression models were adjusted for important non-lifestyle factors then further adjusted for dietary and physical activity variables. In total, 91 adolescents were studied.
Each serving of total dairy (β = -0.0054, P < 0.01), unflavored milk (β = -0.012, P < 0.01), reduced fat (β = -0.0078, P < 0.05), and low fat/fat-free products (β = -0.0149, P < 0.01) was associated with a decrease in zBMI over 12 months. These associations were no longer significant after adjustment for other dietary and physical activity factors. Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
Intakes of total dairy, unflavored milk, reduced fat dairy and low fat/fat-free dairy products are associated with improved obesity treatment outcomes among adolescents. This could be due to co-occurring healthy lifestyle behaviors or to replacement of other food and beverages associated with obesity, such as sugar-sweetened beverages, by dairy products.
Journal Article
Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial
2025
Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioral change strategies have been proposed as the first-line weight management approach for children and adolescents with obesity. Nonpharmacological interventions, such as traditional Chinese medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly being investigated in the young obese population. However, there is limited high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in the pediatric population.
This study aimed to compare the effect of cardiometabolic risk reduction between TCM auricular acupressure treatment (TAAT) and ILCD in children with overweight or obesity with gastric-heat and dampness-obstruction syndrome.
This is a randomized controlled trial. Eligible participants are children with overweight or obesity and enrolled at the obesity clinic of the department of TCM at a tertiary children's hospital. Eligible participants must meet the following criteria: (1) be aged between 6 and 18 years, (2) be overweight, and (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized 3:1 to receive either TAAT or a self-administered ILCD for 1 month: 150 in the TAAT group and 50 in the ILCD group. The primary outcome is the change in body weight from the beginning of treatment to the end of 1 month. Secondary outcomes included body weight, waist circumference, waist-to-height ratio, BMI, blood pressure, body fat content, indexes of liver and renal function, indexes of glucose metabolism, gut microbiota, and TCM syndrome scores at the end of 1 month and 3 months, respectively. Primary statistical analyses were conducted using the intention-to-treat strategy. A generalized linear model was used to compare the difference in weight change between the groups, with the baseline body weight as the covariate, to obtain the estimate of the mean difference in body weight change and its 95% CI, using Gaussian for family function and identity for link function.
The study protocol was approved by the institutional ethical committee and registered on ClinicalTrials.gov on May 5, 2023, before recruitment. Recruitment began in June 2023 and is expected to be completed by December 2025. As of November 2024, we have enrolled 112 participants.
This randomized controlled trial will provide evidence on the treatment effects and safety of TAAT versus ILCD among children with overweight or obesity with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the 2 kinds of interventions, based on biosamples.
ClinicalTrials.gov NCT05847478. https://clinicaltrials.gov/study/NCT05847478.
DERR1-10.2196/59856.
Journal Article
Effects of school-based high-intensity interval training on body composition, cardiorespiratory fitness and cardiometabolic markers in adolescent boys with obesity: a randomized controlled trial
2022
Background
With accumulating evidence suggesting that CVD has its origins in childhood obesity. The purpose of this study was to determine the effect of a real-world school-based high-intensity interval training intervention on body composition, cardiorespiratory fitness and cardiometabolic markers in obese boys aged 10 to 13 years.
Methods
Forty-five adolescent boys with obesity (age = 11.2 ± 0.7 years, BMI = 24.2 ± 1.0 kg/m
2
), were randomized to high-intensity interval training group (HIIT,
n
= 15), moderate-intensity continuous training group (MICT,
n
= 15), or a control group (CON,
n
= 15). The intervention groups performed three weekly exercise sessions over 12 weeks. HIIT group performed two sets of eight bouts of 15 s run at high-intensity [90 ~ 100% maximal aerobic speed (MAS)] separated by eight bouts of 15 s recovery run at low-intensity (50% MAS), MICT group performed 30 min run at moderate intensity (60 ~ 70% MAS) and CON group were instructed to continue their normal behaviors. All participants had indices of body composition, cardiorespiratory fitness (CRF) and cardiometabolic markers measured at baseline and post-intervention. Statistical differences between and within groups were determined by use of two-way analysis of variance (ANOVA) with repeated measures.
Results
Following the school-based training program, BMI and body fat mass decreased (BMI: − 1.8 kg/m
2
vs. – 1.2 kg/m
2
,
P
< 0.01; FM: − 1.6 kg,
P
< 0.05 vs. -3.7 kg,
P
< 0.01) in HIIT and MICT group, but there was no significant difference between the two interventions;
V
˙
O
2
peak
both increased significantly in two intervention groups, and the increment of HIIT group was significantly greater than that of MICT (6.1 mL/kg/min vs. 3.8 mL/kg/min,
P
< 0.01), Visceral adipose tissue was significant decrease in HIIT group (− 53 g vs. -17 g,
P
< 0.01) whilst the MICT group experienced a significant decrease in body fat percentage (− 3.1 ± 1.0 kg,
P
< 0.01), but there were no significant difference between the two interventions. Low-density lipoprotein cholesterol decreased only in HIIT group (− 17.2%,
P
< 0.05). Significant decrease in the usual index of insulin resistance (HOMA-IR) occurred in HIIT and MICT groups (− 27.3 and − 28.6%, respectively;
P
< 0.05).
Conclusions
Our results demonstrated that high-intensity interval training based on running can be used to improve the physical health of obese adolescents in school. Further investigations involving a larger cohort of participants, taken from different schools, is recommended.
Trial registration
title
Effect of High Intensity Interval Training on Obese Children and Adolescents,
time
16/12/2017,
ID
ChiCTR-IOR-17013992
,
website
http://www.chictr.org.cn
Journal Article
Effects of Fecal Microbiome Transfer in Adolescents With Obesity
by
Svirskis, Darren M.
,
Albert, Benjamin B.
,
Jiang, Yannan
in
Adolescent
,
Body Mass Index
,
Diabetes and Endocrinology
2020
Treatment of pediatric obesity is challenging. Preclinical studies in mice indicated that weight and metabolism can be altered by gut microbiome manipulation.
To assess efficacy of fecal microbiome transfer (FMT) to treat adolescent obesity and improve metabolism.
This randomized, double-masked, placebo-controlled trial (October 2017-March 2019) with a 26-week follow-up was conducted among adolescents aged 14 to 18 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 30 or more in Auckland, New Zealand. A total of 87 individuals took part-565 individuals responded to advertisements, 328 were ineligible, and 150 declined participation. Clinical data were analyzed from September 2019 to May 2020.
Single course of oral encapsulated fecal microbiome from 4 healthy lean donors of the same sex or saline placebo.
Primary outcome was BMI standard deviation score at 6 weeks using intention-to-treat analysis. Secondary outcomes included body composition, cardiometabolic parameters, well-being, and gut microbiome composition.
Eighty-seven participants (59% female adolescents, mean [SD] age 17.2 [1.4] years) were randomized 1:1, in groups stratified by sex, to FMT (42 participants) or placebo (45 participants). There was no effect of FMT on BMI standard deviation score at 6 weeks (adjusted mean difference [aMD] -0.026; 95% CI -0.074, 0.022). Reductions in android-to-gynoid-fat ratio in the FMT vs placebo group were observed at 6, 12, and 26 weeks, with aMDs of -0.021 (95% CI, -0.041 to -0.001), -0.023 (95% CI, -0.043 to -0.003), and -0.029 (95% CI, -0.049 to -0.008), respectively. There were no observed effects on insulin sensitivity, liver function, lipid profile, inflammatory markers, blood pressure, total body fat percentage, gut health, and health-related quality of life. Gut microbiome profiling revealed a shift in community composition among the FMT group, maintained up to 12 weeks. In post-hoc exploratory analyses among participants with metabolic syndrome at baseline, FMT led to greater resolution of this condition (18 to 4) compared with placebo (13 to 10) by 26 weeks (adjusted odds ratio, 0.06; 95% CI, 0.01-0.45; P = .007). There were no serious adverse events recorded throughout the trial.
In this randomized clinical trial of adolescents with obesite, there was no effect of FMT on weight loss in adolescents with obesity, although a reduction in abdominal adiposity was observed. Post-hoc analyses indicated a resolution of undiagnosed metabolic syndrome with FMT among those with this condition. Further trials are needed to confirm these results and identify organisms and mechanisms responsible for mediating the observed benefits.
Australian New Zealand Clinical Trials Registry Identifier: ACTRN12615001351505.
Journal Article