Childhood obesity prevention cluster randomized trial for Hispanic families: outcomes of the healthy families study.
ABSTRACT: BACKGROUND:Obesity prevalence is disproportionately high among Hispanic children. OBJECTIVES:The Healthy Families Study assessed the efficacy of a culturally targeted, family-based weight gain prevention intervention for Hispanic immigrant families with children ages 5-7?years. METHODS:The study used a two-group, cluster randomized trial design, assigning 136 families (clusters) to the active intervention (weight gain prevention) and 136 families to attention control (oral health). The active intervention included a 4-month intensive phase (eight classes) and an 8-month reinforcement phase (monthly mail/telephone contact). Children's body mass index z-score (BMI-Z) was the primary outcome. RESULTS:The BMI-Z growth rate of the active intervention group did not differ from the attention control group at short-term follow-up (median 6?months; 168 families, 206 children) or long-term follow-up (median 16?months; 142 families, 169 children). Dose response analyses indicated a slower increase in BMI-Z at short term among overweight/obese children who attended more intervention classes. Moderate physical activity on weekends increased at short term. Weekend screen time decreased at short term among those attending at least one class session. CONCLUSION:Low class attendance likely impacted intention-to-treat results. Future interventions targeting this population should test innovative strategies to maximize intervention engagement to produce and sustain effects on weight gain prevention.
Project description:BACKGROUND:The childhood obesity epidemic disproportionately affects Hispanics. This paper reports on the design of the ongoing Healthy Families Study, a randomized controlled trial testing the efficacy of a community-based, behavioral family intervention to prevent excessive weight gain in Hispanic children using a community-based participatory research approach. METHODS:The study will enroll 272 Hispanic families with children ages 5-7 residing in greater Nashville, Tennessee, United States. Families are randomized to the active weight gain prevention intervention or an alternative intervention focused on oral health. Lay community health promoters implement the interventions primarily in Spanish in a community center. The active intervention was adapted from the We Can! parent program to be culturally-targeted for Hispanic families and for younger children. This 12-month intervention promotes healthy eating behaviors, increased physical activity, and decreased sedentary behavior, with an emphasis on parental modeling and experiential learning for children. Families attend eight bi-monthly group sessions during four months then receive information and/or support by phone or mail each month for eight months. The primary outcome is change in children's body mass index. Secondary outcomes are changes in children's waist circumference, dietary behaviors, preferences for fruits and vegetables, physical activity, and screen time. RESULTS:Enrollment and data collection are in progress. CONCLUSION:This study will contribute valuable evidence on efficacy of a childhood obesity prevention intervention targeting Hispanic families with implications for reducing disparities.
Project description:Background:American Indian (AI) families experience a disproportionate risk of obesity due to a number of complex reasons, including poverty, historic trauma, rural isolation or urban loss of community connections, lack of access to healthy foods and physical activity opportunities, and high stress. Home-based obesity prevention interventions are lacking for these families. Objective:Healthy Children, Strong Families 2 (HCSF2) was a randomized controlled trial of a healthy lifestyle promotion/obesity prevention intervention for AI families. Methods:Four hundred and fifty dyads consisting of an adult primary caregiver and a child ages 2 to 5 y from 5 AI communities were randomly assigned to a monthly mailed healthy lifestyle intervention toolkit (Wellness Journey) with social support or to a child safety control toolkit (Safety Journey) for 1 y. The Wellness Journey toolkit targeted increased fruit/vegetable (F/V) intake and physical activity, improved sleep, decreased added sugar intake and screen time, and improved stress management (adults only). Anthropometrics were collected, and health behaviors were assessed via survey at baseline and at the end of Year 1. Adults completed surveys for themselves and the participating child. Repeated measures analysis of variance was used to assess change over the intervention period. Results:Significant improvements to adult and child healthy diet patterns, adult F/V intake, adult moderate-to-vigorous physical activity, home nutrition environment, and adult self-efficacy for health behavior change were observed in Wellness Journey compared with Safety Journey families. No changes were observed in adult body mass index (BMI), child BMI z-score, adult stress measures, adult/child sleep and screen time, or child physical activity. Qualitative feedback suggests the intervention was extremely well-received by both the families and our community partners across the 5 participating sites. Conclusions:This multi-site community-engaged intervention addressed key gaps regarding family home-based approaches for early obesity prevention in AI communities and showed several significant improvements in health behaviors. Multiple communities are working to sustain intervention efforts. This trial was registered at clinicaltrials.gov as NCT01776255.
Project description:The rise in pediatric obesity since the 1970s has been well established in the United States and is becoming a major concern worldwide. As a potential means to help slow the obesity epidemic, low-calorie sweeteners (LCS) have gained attention as dietary tools to assist in adherence to weight loss plans or prevention of excess weight gain. Observational studies tend to show positive correlations between LCS consumption and weight gain in children and adolescents. Although the data are intriguing, these epidemiologic studies do not establish that LCS cause weight gain, because there are likely many lifestyle and genetic differences between children and families who choose to consume LCS and those who do not. Short-term randomized controlled trials have shown LCS use to be BMI neutral or to have modest weight-reducing effects in overweight and obese adolescents. The long-term effects of LCS in children and adolescents are unknown. Some compelling research is currently underway and may provide needed insight into the potential role of LCS in weight management. The paucity of data regarding the effects of LCS use in children and adolescents creates challenges in decision-making for health care providers and parents.
Project description:The one-year outcome of the randomized controlled T.A.F.F. (Telephone based Adiposity prevention For Families) study is presented. Screening of overweight (BMI-SDS > 90th centile) children 3.5-17.4 years was performed via the German CrescNet database, and candidates were randomized to an intervention group (IG) and control group (CG). The intervention consisted of computer-aided telephone counselling for one year, supported by mailed newsletters. The primary endpoint was change in BMI-SDS; secondary endpoints were eating behavior, physical activity, media consumption, quality of life. Data from 289 families (145 IG (51% females); 144 CG (50% females)) were analyzed (Full Analysis Set: FAS; Per Protocol Set: PPS). Successful intervention was defined as decrease in BMI-SDS ? 0.2. In the FAS, 21% of the IG was successful as compared to 16% from the CG (95% CI for this difference: (-4, 14), p = 0.3, mean change in BMI-SDS: -0.02 for IG vs. 0.02 for CG; p = 0.4). According to the PPS, however, the success rate was 35% in the IG compared to 19% in the CG (mean change in BMI-SDS: -0.09 for IG vs. 0.02 for CG; p = 0.03). Scores for eating patterns (p = 0.01), media consumption (p = 0.007), physical activity (p = 9 × 10-9), quality of life (p = 5 × 10-8) decreased with age, independent of group or change in BMI-SDS. We conclude that a telephone-based obesity prevention program suffers from well-known high attrition rates so that its effectiveness could only be shown in those who adhered to completion. The connection between lifestyle and weight status is not simple and requires further research to better understand.
Project description:Obesity prevention in children offers a unique window of opportunity to establish healthful eating and physical activity behaviors to maintain a healthful body weight and avoid the adverse proximal and distal long-term health consequences of obesity. Given that obesity is the result of a complex interaction between biological, behavioral, family-based, and community environmental factors, intervention at multiple levels and across multiple settings is critical for both short- and long-term effectiveness. The Minnesota NET-Works (Now Everybody Together for Amazing and Healthful Kids) study is one of four obesity prevention and/or treatment trials that are part of the Childhood Obesity Prevention and Treatment (COPTR) Consortium. The goal of the NET-Works study is to evaluate an intervention that integrates home, community, primary care and neighborhood strategies to promote healthful eating, activity patterns, and body weight among low income, racially/ethnically diverse preschool-age children. Critical to the success of this intervention is the creation of linkages among the settings to support parents in making home environment and parenting behavior changes to foster healthful child growth. Five hundred racially/ethnically diverse, two-four year old children and their parent or primary caregiver will be randomized to the multi-component intervention or to a usual care comparison group for a three-year period. This paper describes the study design, measurement and intervention protocols, and statistical analysis plan for the NET-Works trial.
Project description:Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described. Methods Healthy Children, Strong Families 2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two less-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyle intervention ( Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group ( Safety Journey) for 1?year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities' request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities' request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a 2-year study. Conclusion This multisite intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. Healthy Children, Strong Families 2's innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and less-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families.
Project description:BACKGROUND:The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2 years of age, compared to usual care (Control group). The study had high uptake at recruitment (58 %) and retention at 2 years (86 %). Although the FAB intervention produced no significant effect on BMI or weight status at 2 years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2 years of life reduces BMI at 3.5 and 5 years of age, and to determine the role of self-regulation in any such relationship. METHODS/DESIGN:We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2 years of age. Follow-up data collection will occur when the children are aged 3.5 and 5 years (i.e. up to 3 years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment). DISCUSSION:Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2 years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention. TRIAL REGISTRATION:ClinicalTrials.gov number NCT00892983 .
Project description:<h4>Background</h4>Childhood obesity persists as a serious public health problem. In the current meta-analysis, we summarized the results of controlled trials that evaluated the effect of obesity prevention policies in children and adolescents.<h4>Methods</h4>Three databases (SCOPUS, PubMed and Embase) were searched for studies published before the 6th April 2020, by reported outcome measures of body mass index (BMI) and BMI-Z<sub>score</sub>. Forty-seven studies reported BMI, while 45 studies reported BMI-Z<sub>score</sub> as final outcome.<h4>Results</h4>The results showed that the obesity-prevention policies had significant effect in reducing BMI (WMD: - 0.127; CI - 0.198, - 0.056; P?<?0.001). These changes were not significant for BMI-Z<sub>score</sub> (WMD: - 0.020; CI - 0.061, 0.021; P?=?0.340). In dose-response meta-analysis, a non-linear association was reported between the duration of intervention and BMI (P<sub>nonlinearity</sub>?<?0.001) as well as BMI-Z<sub>score</sub> (P<sub>nonlinearity</sub>?=?0.023). In subgroup analysis, the more favorite results were observed for 5-10 years old, with combination of physical activity and diet as intervention materials.<h4>Conclusion</h4>In conclusion, the obesity prevention policies in short-term periods of less than 2 years, in rather early age of school with approaches of change in both of diet and physical activity, could be more effective in prevention of childhood obesity. Trial registration PROSPERO registration number: CRD42019138359.
Project description:To evaluate the effectiveness of a school-based intervention involving the families and teachers that aimed to promote healthy eating habits in adolescents; the ultimate aim of the intervention was to reduce the increase in body mass index (BMI) of the students.Paired cluster randomized school-based trial conducted with a sample of fifth graders.Twenty classes were randomly assigned into either an intervention group or a control group.From a total of 574 eligible students, 559 students participated in the study (intervention: 10 classes with 277 participants; control: 10 classes with 282 participants). The mean age of students was 11 years.Students attended 9 nutritional education sessions during the 2010 academic year. Parents/guardians and teachers received information on the same subjects.Changes in BMI and percentage of body fat.Intention-to-treat analysis showed that changes in BMI were not significantly different between the 2 groups (??=?0.003; p?=?0.75). There was a major reduction in the consumption of sugar-sweetened beverages and cookies in the intervention group; students in this group also consumed more fruits.Encouraging the adoption of healthy eating habits promoted important changes in the adolescent diet, but this did not lead to a reduction in BMI gain. Strategies based exclusively on the quality of diet may not reduce weight gain among adolescents.Clinicaltrials.gov NCT01046474.
Project description:Most school-based obesity prevention programs in low- to middle-income countries are of short duration, and few undertake follow-up analyses after the termination of the project. The aims of the current study are to investigate (1) the long-term effects of a school-based intervention program when implemented over two years on body mass index (BMI), healthy dietary behaviors, and physical activity (PA); and (2) whether the effects are sustained after one-year washout. The study is a cluster-randomized trial; 36 public and private schools were randomized into either intervention or control groups. Students (8-12 years) completed pre-and post-assessment anthropometric measurements and questionnaires about their eating and physical activity habits. Students in the intervention groups received the program components for two consecutive years. Multiple logistic regression models were used to examine the effect of the intervention on BMI and healthy behaviors. Students in the intervention groups were less likely to be overweight at washout, only in public schools. The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools. Policies aiming at securing a positive nutrition environment in schools, and adoption of nutrition programs, are needed for achieving sustained behavior and prompting BMI changes in children.