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Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.

ABSTRACT: INTRODUCTION:Treatment of childhood obesity is a complex challenge for primary health care professionals. OBJECTIVES:To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. METHODS:Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. RESULTS:At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). CONCLUSIONS:At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. TRIAL REGISTRATION:ClinicalTrials.gov NCT01878994.

SUBMITTER: Serra-Paya N

PROVIDER: S-EPMC4684233 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.

Serra-Paya Noemi N Ensenyat Assumpta A Castro-Viñuales Iván I Real Jordi J Sinfreu-Bergués Xènia X Zapata Amalia A Mur Jose María JM Galindo-Ortego Gisela G Solé-Mir Eduard E Teixido Concepció C

PloS one 20151214 12

<h4>Introduction</h4>Treatment of childhood obesity is a complex challenge for primary health care professionals.<h4>Objectives</h4>To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake.<h4>Methods</h4>Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 y ...[more]

PMID: 26658988

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Project description:BackgroundChildhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children.MethodsThe Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm.DiscussionThis study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children.Trial registrationNCT01574352 at http://clinicaltrials.gov on the 8th of March 2012.

Project description:BACKGROUND:This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. METHODS:Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. RESULTS:Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups. CONCLUSIONS:Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

Project description:Pediatric studies have shown that aerobic exercise reduces metabolic risk, but dose-response information is not available.To test the effect of different doses of aerobic training on insulin resistance, fatness, visceral fat, and fitness in overweight, sedentary children and to test moderation by sex and race.Randomized controlled efficacy trial conducted from 2003 through 2007 in which 222 overweight or obese sedentary children (mean age, 9.4 years; 42% male; 58% black) were recruited from 15 public schools in the Augusta, Georgia, area.Children were randomly assigned to low-dose (20 min/d; n = 71) or high-dose (40 min/d; n = 73) aerobic training (5 d/wk; mean duration, 13 [SD, 1.6] weeks) or a control condition (usual physical activity; n = 78).The prespecified primary outcomes were postintervention type 2 diabetes risk assessed by insulin area under the curve (AUC) from an oral glucose tolerance test, aerobic fitness (peak oxygen consumption [VO2]), percent body fat via dual-energy x-ray absorptiometry, and visceral fat via magnetic resonance, analyzed by intention to treat.The study had 94% retention (n = 209). Most children (85%) were obese. At baseline, mean body mass index was 26 (SD, 4.4). Reductions in insulin AUC were larger in the high-dose group (adjusted mean difference, -3.56 [95% CI, -6.26 to -0.85] × 10(3) ?U/mL; P = .01) and the low-dose group (adjusted mean difference, -2.96 [95% CI, -5.69 to -0.22] × 10(3) ?U/mL; P = .03) than the control group. Dose-response trends were also observed for body fat (adjusted mean difference, -1.4% [95% CI, -2.2% to -0.7%]; P < .001 and -0.8% [95% CI, -1.6% to -0.07%]; P = .03) and visceral fat (adjusted mean difference, -3.9 cm3 [95% CI, -6.0 to -1.7 cm3]; P < .001 and -2.8 cm3 [95% CI, -4.9 to -0.6 cm3]; P = .01) in the high- and low-dose vs control groups, respectively. Effects in the high- and low-dose groups vs control were similar for fitness (adjusted mean difference in peak VO2, 2.4 [95% CI, 0.4-4.5] mL/kg/min; P = .02 and 2.4 [95% CI, 0.3-4.5] mL/kg/min; P = .03, respectively). High- vs low-dose group effects were similar for these outcomes. There was no moderation by sex or race.In this trial, after 13 weeks, 20 or 40 min/d of aerobic training improved fitness and demonstrated dose-response benefits for insulin resistance and general and visceral adiposity in sedentary overweight or obese children, regardless of sex or race.clinicaltrials.gov Identifier: NCT00108901.

Project description:Too much prolonged sitting is a prevalent health risk among adults. Interventions have focused mainly on the workplace, with limited attention to non-work settings. The effectiveness of a short-term intervention to reduce and break-up sitting-time in overweight/obese adults was examined. This pilot study sought to determine the feasibility of interrupting sitting to stand/ambulate objectively with ActivPAL devices which provide a valid measurement of sit/stand transitions.This is a cross-over randomized controlled pilot that included 10 participants (aged 37-65 years) and although a small and short-term intervention (1-week intervention; no washout) further informs on the feasibility of interventions on a larger scale. At the workplace, screen-delivered hourly alerts prompted participants to break-up sitting-time through adopting walking behaviors (approximately 30-60 minutes day(-1)). During transportation/home/leisure-time individual goals for steps day(-1) were set and sitting-reduction strategies (including behavioral self-monitoring) were delivered through daily text messages. Change in inclinometer-derived sitting-time is the main outcome. Standing, stepping, number of sit/stand transitions and participant satisfaction were also examined.For the intervention compared to the control-week (mean difference (95 % confidence interval); p value), participants had less sitting-time (1.85 hours (0.96-2.75); p?=?0.001), more standing (0.77 hours (0.06-1.48); p?=?0.036), and more stepping (1.09 hours (0.79- 1.38); p?<?0.001). Importantly, there was no change in the total number of sit/stand transitions (3.28 (-2.33-8.89); p?=?0.218) despite successfully reducing sitting-time and increasing time spent standing and walking.Sitting-time in overweight/obese adults can be reduced following a brief multi-component intervention based on prompts, telephone support, goal setting and behavioral self-monitoring. However, the results from this pilot study provide new insight that when overweight/obese adults attempted to reduce sedentary-time by walking and standing for approximately 2 hour day(-1) more than usual, they did not actually get up from sitting more often (i.e. increasing the number of sit/stand transitions), but instead remained on their feet for longer during each non-sitting bout. This behavioral resistance to make more sit/stand transitions (i.e. get-up from sitting more often) may have important implications for future modification programs and supports the concept that when overweight/obese people are sitting, people seem to prefer not to interrupt the sedentary behavior to get-up from sitting.26 November 2013, ClinicalTrials.govID: NCT02007681 (first participant was randomized on 2 September 2013).

Dataset Information

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.

Publications

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.

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