Brighter Bites for Childhood Obesity
Recruiting in Palo Alto (17 mi)
Overseen byShreela Sharma, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Disqualifiers: Special needs, Physical, Cognitive, Psychological, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the Brighter Bites treatment for childhood obesity?
Research shows that successful childhood obesity treatments often involve changes in diet and physical activity, along with family support. Programs that include these elements, like Brighter Bites, can help children develop healthier habits and reduce obesity.
12345Is the Brighter Bites program safe for children with obesity?
The existing literature on very low-energy diet programs, which may be similar to Brighter Bites, indicates that while they are effective for weight loss in children and adolescents, there is limited information on their safety. Future studies should include comprehensive monitoring of any adverse events to better understand safety.
45678How does the Brighter Bites treatment for childhood obesity differ from other treatments?
The Brighter Bites treatment is unique because it focuses on providing fresh produce and nutrition education to families, aiming to improve eating habits and lifestyle choices, rather than relying on high-intensity, family-based interventions or pharmacological approaches.
910111213Eligibility Criteria
This trial is for children and their parents living in areas of persistent poverty, who are facing issues with obesity and cardiometabolic health. The study aims to include families willing to participate in a fruit and vegetable co-op program. Specific medical criteria like HbA1c levels may be considered.Inclusion Criteria
High proportion of children participating in the free and reduced lunch (FRL) program (>70%)
I am willing to start a school health program.
I am a student in the 1st, 2nd, or 3rd grade.
Exclusion Criteria
Prior participation in BB in the previous school year
I or my child have a condition that makes it hard to participate in certain activities.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive the Brighter Bites intervention, including fruit and vegetable distributions, healthy recipe tastings, and nutrition education
9 months
Regular visits for intervention activities
Post-intervention Assessment
Assessment of primary and secondary outcomes, including child vegetable intake, HbA1c levels, and household food security status
1 month
In-person assessments
Follow-up
Participants are monitored for long-term effects of the intervention on diet, adiposity, and metabolic outcomes
21 months
Participant Groups
The 'Brighter Bites' intervention is being tested against a wait-list control group to see if it improves kids' health by increasing vegetable intake, improving household food security, and changing dietary behaviors over nine months.
2Treatment groups
Experimental Treatment
Active Control
Group I: Brighter BitesExperimental Treatment1 Intervention
This group will receive the Brighter Bites intervention throughout the study implementation. The intervention includes fruit and vegetable distributions of \~20lbs. for teachers and families, healthy recipe tastings, and nutrition education.
Group II: Control groupActive Control1 Intervention
This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.
Brighter Bites is already approved in United States for the following indications:
🇺🇸 Approved in United States as Brighter Bites for:
- Improving access to fruits and vegetables among low-income children and families
- Nutrition education
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Treatment of pediatric obesity. [2007]The primary goal of childhood obesity interventions is regulation of body weight and fat with adequate nutrition for growth and development. Ideally, these interventions are associated with positive changes in the physiologic and psychological sequelae of obesity. To contribute to long-term weight maintenance, interventions should modify eating and exercise behaviors such that new, healthier behaviors develop and replace unhealthy behaviors, thereby allowing healthier behaviors to persist throughout development and into adulthood. This overview of pediatric obesity treatment, using predominantly randomized, controlled studies, highlights important contributions and developments in primarily dietary, activity, and behavior change interventions, and identifies characteristics of successful treatment and maintenance interventions. Potential positive (eg, reduction in blood pressure, serum lipids, and insulin resistance) and negative (eg, development of disordered eating patterns) side effects of treatment also are described. Recommendations for improving implementation of childhood obesity treatments, including application of behavioral choice theory, improving knowledge of response extinction and recovery in regards to behavior relapse, individualization of treatment, and integration of basic science with clinical outcome research, are discussed.
[Dietary interventions and social care for treating obesity in children]. [2016]The prevalence of obesity and associated comorbidities among children and adolescents has risen worldwide throughout the past 3 decades. To break this trend, population-based activities in health promotion/prevention and health care are necessary. Studies showed that long-term eating behavior improvement with the cooperation of the patient's family together with child-friendly organization support both individual therapeutic improvements as well as a relevant reduction of obesity prevalence. A significant BMI reduction can be achieved with a normal varied diet, whose energetic value is 300-400 kcal/day below the patient's daily energetic needs, due to the lower consumption of fat and sugar. This requires, however, that the entire family be willing to change their unhealthy eating behaviors (e.g., soft drinks and fast food) and to introduce regular meals into their daily routine. Sensibly, most therapies combine diet therapy with increased physical activity and parental training. Controlled media consumption, active leisure-time behavior, and a structured daily routine are further conditions for successful weight reduction. The high-risk groups for pediatric obesity, i.e., families with migration background and/or low socioeconomic status, have been poorly reached by established programs.
Behavioural treatment of childhood and adolescent obesity. [2022]Current state-of-the-art behavioural treatments for childhood and adolescent obesity, produce long-term weight control in up to one-third of participants. A review of the most effective treatments suggests structural and organizational components and treatment content that are most likely to be successful. These include a group format with individualized behavioural counseling; parent participation; frequent sessions; a long treatment duration; a simple and explicit diet that produces a calorie deficit; a physical activity program emphasizing choice and reinforcing reduced sedentary behaviours; making changes in the home and family environment to help reduce cues and opportunities associated with calorie intake and inactivity, and to increase cues and opportunities for physical activity; self-monitoring; goal setting and contracting; parenting skills training; skills for managing high-risk situations; and skills for maintenance and relapse prevention. Still, there are many unanswered questions about the implementation of all the components of treatment. Further research, to identify treatment approaches that promote long-term maintenance of weight control, is greatly needed.
Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. [2022]This study compares children with severe obesity and children with mild obesity/overweight participating in family-based obesity treatment (FBT) on change in (1) relative weight and adiposity and (2) psychosocial distress.
Targeted dietary approaches for the management of obesity and severe obesity in children and adolescents: A systematic review and meta-analysis. [2023]There is a need for a detailed understanding of effective dietary interventions for children with obesity. This systematic review examined the effectiveness of diets of varying energy content as a component of weight treatment in children and adolescents with obesity, severe obesity and obesity-related comorbidity. A systematic search of six databases, from 2000 to 2021, for intervention studies of targeted dietary treatment for obesity in children aged 2-18 years identified 125 studies. Dietary interventions were grouped according to diet type and energy target. Risk of bias was assessed using the Effective Public Healthcare Panacea Project assessment tool. Meta-analysis examined change in body mass index (BMI) at intervention end. A broad array of diet types were effective at reducing BMI in children with obesity. When dietary types were considered by energy target, a gradient effect was observed. Very-low energy diets were most effective with a - 4.40 kg/m2 (n = 3; 95% CI -7.01 to -1.79). While dietary interventions with no specified energy target were ineffective, resulting in a BMI gain of +0.17 kg/m2 (n = 22; 95% CI 0.05 to 0.40). Practical definitions of dietary energy target in the management of obesity and severe obesity are urgently required to ensure treatment seeking children have timely access to efficacious interventions.
Efficacy of very low-energy diet programs for weight loss: A systematic review with meta-analysis of intervention studies in children and adolescents with obesity. [2020]The objective of this review was to evaluate the efficacy and safety of very low-energy diet (VLED) programs for weight loss in children and adolescents with obesity. Six electronic databases were searched identifying 24 eligible studies (16 pre-post studies, four nonrandomized trials, two randomized controlled trials [RCTs], and two chart reviews) published up to October 2018. Studies were in English, implemented a VLED (≤3360 kJF/day [≤800 kcal/day] or <50% estimated energy requirements) in 5- to 18-year-olds with obesity, and reported at least one weight-related outcome. Weight-related outcomes significantly improved postintervention in all studies. Meta-analysis of 20 studies indicated a mean 10.1 kg (95% confidence interval [CI], 8.7-11.4 kg, P < 0.001; I2  = 92.3%) weight loss following interventions lasting 3 to 20 weeks. Moderator analysis indicated greater weight loss in adolescent-only studies (10-18 years) and formulated meal replacement interventions and inpatient settings. Meta-analysis of seven studies reporting weight at follow-up (5-14.5 months from baseline) indicated 5.3 kg mean weight loss (CI, 2.5-8.0 kg, P < 0.001; I2  = 50.6%). Details of adverse events were limited. VLED programs are effective for treating children and adolescents with obesity. However, conclusions on their safety cannot be drawn from the existing literature at this time. Future studies should include long-term follow-up with ongoing support and comprehensive monitoring of all adverse events.
Obesity in preschoolers: behavioral correlates and directions for treatment. [2022]Nearly 14% of American preschoolers (ages 2-5) are obese (BMI ≥ 95th percentile for age and gender), yet this group has received little attention in the obesity intervention literature. This review examines what is known about behavioral correlates of obesity in preschoolers and the developmental context for lifestyle modification in this age group. Information was used to critically evaluate existing weight management prevention and intervention programs for preschoolers and formulate suggestions for future intervention research development. A systematic search of the medical and psychological/behavioral literatures was conducted with no date restrictions, using PubMed, PsycInfo, and MEDLINE electronic databases and bibliographies of relevant manuscripts. Evidence suggests several modifiable behaviors, such as sugar sweetened beverage intake, television use, and inadequate sleep, may differentiate obese and healthy weight preschoolers. Developmental barriers, such as food neophobia, food preferences, and tantrums challenge caregiver efforts to modify preschoolers' diet and activity and parental feeding approaches, and family routines appear related to the negative eating and activity patterns observed in obese preschoolers. Prevention programs yield modest success in slowing weight gain, but their effect on already obese preschoolers is unclear. Multi-component, family-based, behavioral interventions show initial promise in positive weight management for already obese preschoolers. Given that obesity intervention research for preschoolers is in its infancy, and the multitude of modifiable behavioral correlates for obesity in this age group, we discuss the use of an innovative and efficient research paradigm (Multiphase Optimization Strategy; MOST) to develop an optimized intervention that includes only treatment components that are found to empirically reduce obesity in preschoolers.
Translational research: are community-based child obesity treatment programs scalable? [2021]Community-based obesity treatment programs have become an important response to address child obesity; however the majority of these programs are small, efficacy trials, few are translated into real-world situations (i.e., dissemination trials). Here we report the short-term impact of a scaled-up, community-based obesity treatment program on children's weight and weight-related behaviours disseminated under real world conditions.
Real-world effectiveness of the Bright Bodies healthy lifestyle intervention for childhood obesity. [2023]This study aimed to examine the extent to which Bright Bodies, a high-intensity, family-based pediatric weight management intervention, improved BMI for participants since publication of the randomized controlled trial establishing efficacy in 2007 and to describe adaptations to the program.
Cost-Effectiveness and Long-Term Savings of the Bright Bodies Intervention for Childhood Obesity. [2023]To estimate the cost and cost-effectiveness of Bright Bodies, a high-intensity, family-based intervention that has been demonstrated to improve body mass index (BMI) among children with obesity in a randomized controlled trial.
Design of the FRESH-DOSE study: A randomized controlled noninferiority trial evaluating a guided self-help family-based treatment program for children with overweight or obesity. [2023]Overweight and obesity affect 45% of children and increases the risk for several negative health sequelae. Family-Based Behavioral Treatment (FBT) is the most efficacious treatment for child weight management and consists of nutrition and physical activity education, behavior change skills and parenting skills training. FBT is time and staff intensive and can include 20, 60-min separate groups for parents and children, as well as 20-min behavior coaching sessions to help problem solve barriers to implementing the skills learned and individualize the program. Guided self-help (GSH) therapies involve providing families a manual to review independently and brief coaching sessions by an interventionist to facilitate adherence. We developed a GSH version of FBT (gshFBT) which provides a manual to both parents and children and includes 14, 20-min coaching sessions over 6-months. The current study randomized 150 children (mean age = 10.1 years (SD = 1.38); mean BMI% = 97.3% (SD = 2.84); mean BMIz = 2.09 (SD = 0.40); 49% female; 43% Hispanic) and one of their parents (mean age = 41.8 years (SD = 6.52); mean BMI = 32.0 (SD = 7.24); 87.3% female; 43% Hispanic) to either a group-based FBT program or a gshFBT program. Assessments are conducted at baseline, post-treatment (6 months), 6-month follow-up (12 months) and 12-month follow-up (18 months). Primary outcomes are child weight change (BMIz) and cost effectiveness. Recruitment occurred between May 2017 and October 2021 and follow-up assessments are underway. Given the public health concern for children with obesity and the low level of access to FBT, gshFBT could prove extremely useful to provide intervention to a greater proportion of the population.
An overview of pediatric obesity. [2007]Pediatric obesity is increasing worldwide and disproportionately affects the economically and socially disadvantaged. Obese children are at risk of developing the (dys)metabolic syndrome, insulin resistance, early-onset type 2 diabetes mellitus, polycystic ovarian syndrome, hypertension, hyperlipidemia, and obstructive sleep apnoea. Those with diabetes may have mixed features of type 1 and type 2 diabetes mellitus. Pediatric obesity is the result of persistent adverse changes in food intake, lifestyle, and energy expenditure. It may be because of underlying a genetic syndrome or a conduct disorder. Children living in urban settings often lack safe, affordable, and accessible recreational facilities. Tight educational schedules mean less free time, while computer games and television have become preferred recreational activities. More families are eating out or eating take-out meals and processed foods at home because of pressures of work and time constraints. Consumer advertising targeted at children and the ready availability of vending machines encourage unwise food choices. Some children eat excessively because they are depressed, anxious, sad, or lonely. Often families and obese children are aware of the need for healthy eating and exercise but are unable to translate knowledge into weight loss. Population-based measures such as public education, school meal reforms, child-safe exercise friendly environments, and school-based and community-based exercise programs have been shown to be successful to varying degrees, but there remain individuals who will need special help to overcome obesity. Overeating (e.g. binge eating) may be a manifestation of disordered coping behavior but may also be because of defects in the neural and hormonal control of appetite and satiety. New pharmacological approaches are targeting these areas. We need a coordinated approach involving government, communities, and healthcare providers to provide a continuum of population-based interventions, focused screening, and personalized multidisciplinary interventions for the obese child and family.
Anthropometric and psychosocial changes in obese adolescents enrolled in a Weight Management Program. [2008]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.