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A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol.

ABSTRACT: Childhood obesity gives rise to health complications including impaired musculoskeletal development that associates with increased risk of fractures. Prevention and treatment programs should focus on nutrition education, increasing physical activity (PA), reducing sedentary behaviours, and should monitor bone mass as a component of body composition. To ensure lifestyle changes are sustained in the home environment, programs need to be family-centered. To date, no study has reported on a family-centered lifestyle intervention for obese children that aims to not only ameliorate adiposity, but also support increases in bone and lean muscle mass. Furthermore, it is unknown if programs of such nature can also favorably change eating and activity behaviors. The aim of this study is to determine the effects of a 1 y family-centered lifestyle intervention, focused on both nutrient dense foods including increased intakes of milk and alternatives, plus total and weight-bearing PA, on body composition and bone mass in overweight or obese children.The study design is a randomized controlled trial for overweight or obese children (6-8 y). Participants are randomized to control, standard treatment (StTx) or modified treatment (ModTx). This study is family-centred and includes individualized counselling sessions on nutrition, PA and sedentary behaviors occurring 4 weeks after baseline for 5 months, then at the end of month 8. The control group receives counselling at the end of the study. All groups are measured at baseline and every 3 months for the primary outcome of changes in body mass index Z-scores. At each visit blood is drawn and children complete a researcher-administered behavior questionnaire and muscle function testing. Changes from baseline to 12 months in body fat (% and mass), waist circumference, lean body mass, bone (mineral content, mineral density, size and volumetric density), dietary intake, self-reported PA and sedentary behaviour are examined.This family-centered theory-based study permits for biochemical and physiological assessments. This trial will assess the effectiveness of the intervention at changing lifestyle behaviours by decreasing adiposity while enhancing lean and bone mass. If successful, the intervention proposed offers new insights for the management or treatment of childhood obesity.ClinicalTrials.gov, NCT01290016.

SUBMITTER: Cohen TR

PROVIDER: S-EPMC3648398 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol.

Cohen Tamara R TR Hazell Tom J TJ Vanstone Catherine A CA Plourde Hugues H Rodd Celia J CJ Weiler Hope A HA

BMC public health 20130425

<h4>Background</h4>Childhood obesity gives rise to health complications including impaired musculoskeletal development that associates with increased risk of fractures. Prevention and treatment programs should focus on nutrition education, increasing physical activity (PA), reducing sedentary behaviours, and should monitor bone mass as a component of body composition. To ensure lifestyle changes are sustained in the home environment, programs need to be family-centered. To date, no study has rep ...[more]

PMID: 23617621

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Project description:BACKGROUND:Technology-in particular, access to the Internet from a mobile device-has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE:A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS:A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS:Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; P>.05). CONCLUSIONS:Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. TRIAL REGISTRATION:ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583.

Project description:IntroductionThere has been a steep increase in the prevalence of adolescent overweight and obesity globally and in India, demonstrating that present prevention strategies are insufficient. Available evidence suggests that multifactorial interventions may improve short-term physical activity (PA), nutrition and psychological behaviour of overweight and obese adolescents but long-term follow-ups and strategies are needed. This study will investigate the effects of a structured multifactorial (school-based and family-based) intervention on adolescent obesity, compared with a single or no intervention.Methods and analysisA pragmatic, clustered randomised controlled trial with 12 weeks of interventions and 3-month, 6-month and 12-month follow-ups will be conducted at multiple participating schools in Karnataka, India. The participants will be overweight and obese male and female adolescents aged 11-16 years and will be randomly assigned by school into three groups: group A (multifactorial intervention, exercise and dietary advice); group B (exercise only); and group C (controls, no interventions). Primary outcome measures are the level of PA and body composition. Secondary outcomes are dietary change, behaviour change, food behaviours, cardiovascular and muscular fitness, quality of life, parental behaviours (physical and mental) and family functioning. Positive intervention results may reduce obesity in adolescents and promote a healthier lifestyle for students and families. A larger, culturally diverse population can benefit from a similar methodology.Ethics and disseminationThe study has been approved by the Institutional Research and Ethics Committee (IEC 536-2018), Kasturba Hospital, Manipal, Udupi District, Karnataka, India. A written and verbal informed consent (supplemental material) will be provided to the participants prior to participation. On completion of the trial, the results can be communicated to adolescents and their parents on request, and will be published at national and international conferences and in peer-reviewed journals.Trial registration numberCTRI/2019/04/018834.

Dataset Information

A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol.

Publications

A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol.

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