Behavioral Interventions for Childhood Obesity

Recruiting at 1 trial location

Overseen By Filoteia Popescu

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Weight management

Disqualifiers: Developmental delay, Disordered eating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different amounts of intensive behavioral therapy (IBT) can help children with obesity improve their health. Researchers will randomly assign children and their caregivers to one of five groups, each receiving varying hours of therapy that includes guidance on diet, exercise, and lifestyle changes. The goal is to assess how these changes affect the children's body mass index (BMI), diet, exercise habits, sleep, media use, and overall quality of life over a year. The trial seeks children aged 5-17 in Tennessee and Louisiana who have obesity and are willing to make lifestyle changes with their caregivers' support. As an unphased trial, this study offers a unique opportunity for families to contribute to understanding effective lifestyle interventions for childhood obesity.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but children taking weight management medications cannot participate.

What prior data suggests that these behavioral interventions are safe for children with obesity?

Research has shown that significant changes to diet, exercise, and daily habits are generally safe for children. These programs help kids and teens lose weight. Studies have found that families working together on these changes achieve better results than with regular care. While these programs are usually manageable, they require active involvement from both kids and their caregivers. The goal is to implement practical changes that fit safely into everyday life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral interventions for childhood obesity because they offer a personalized and comprehensive approach that extends beyond typical treatments like medication and surgery. Unlike standard options, these interventions focus on teaching healthy lifestyle changes through personalized nutrition counseling, web-based learning, and community support sessions. The unique aspect is the varying intensity and duration of the interventions, allowing for tailored plans that can fit different needs and schedules. This holistic and customizable approach could lead to sustainable healthy habits, potentially improving long-term outcomes for children.

What evidence suggests that these behavioral interventions could be effective for childhood obesity?

Research has shown that changes to diet, exercise, and daily habits can help reduce obesity in children. Studies indicate that children receiving treatment involving their families tend to achieve better weight outcomes than those receiving standard care. One study found that these treatments significantly improved children's BMI (body mass index, which measures body fat based on height and weight) over two years. This trial will compare various levels of intensive behavioral lifestyle interventions, ranging from 13-hour to 26-hour programs, to determine their effectiveness. Another study demonstrated that different levels of intensive health behavior programs can be effective, highlighting the importance of both the amount and quality of treatment. Overall, these programs aim to improve children's health by encouraging better eating, more physical activity, and healthier lifestyle choices. ^{1 2 6 7 8}

Who Is on the Research Team?

William Heerman, MD MPH

Principal Investigator

Vanderbilt University Medical Center

Amanda Staiano, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for children aged 5-17 living in Tennessee or Louisiana who are dealing with obesity. The study involves the child and their caregiver, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Patient of a participating clinical practice

Willing to make behavioral and lifestyle changes

Able to access the internet to participate in online intervention components

Exclusion Criteria

Families for whom the primary care provider (PCP) or site principal investigator (PI) thinks the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, disordered eating, mobility impairments, cognitive or mental difficulties)

Participant caregiver-child dyad has plans to move during the 12-month study and will no longer be a patient of a participating clinic

My child is currently on medication for weight management.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intensive behavioral therapy (IBT) with varying contact hours (13, 16, 19, 22, or 26 hours) over six months, including visits with primary care providers, web-based learning, and community resource counseling.

6 months

4 visits (in-person), on-demand web-based modules, 4 community resource sessions

Follow-up

Participants are monitored for changes in BMI, diet, exercise, sleep, media use, and quality of life after treatment

6 months

5 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Behavioral Lifestyle Modification

Trial Overview The trial is testing how different amounts of Intensive Behavioral Therapy (IBT) affect childhood obesity. Children are randomly placed into groups to receive either 26, 22, 19, 16, or 13 hours of IBT over six months. Health changes will be tracked through BMI and lifestyle factors like diet and exercise.

How Is the Trial Designed?

Group I: 26-hour intensive behavioral lifestyle intervention Experimental Treatment 1 Intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session).

Group II: 16-hour intensive behavioral lifestyle intervention Active Control 1 Intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 8 sessions (45 minutes per session).

Group III: 22-hour intensive behavioral lifestyle intervention Active Control 1 Intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 12 sessions (60 minutes per session).

Group IV: 19-hour intensive behavioral lifestyle intervention Active Control 1 Intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professiona for 9 sessions (60 minutes per session).

Group V: 13-hour intensive behavioral lifestyle intervention Active Control 1 Intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 6 sessions (30 minutes per session).

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

Published Research Related to This Trial

Both short-stay (2 months) and long-stay (6 months) intensive lifestyle treatments for severely obese children resulted in significant reductions in SDS-BMI after one year, indicating that both approaches are effective.

There were no significant differences in outcomes between the two treatment durations, suggesting that the shorter treatment may be preferable due to its lower burden on children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. Makkes, S., Renders, CM., Bosmans, JE., et al.[2023]

In a study of 248 overweight and obese children aged 8-14, those with Caucasian parents, lower baseline BMI-SDS, and higher social competence scores showed greater reductions in BMI-SDS after one year of a family-based lifestyle intervention.

Children with non-overweight parents and younger age also had better success in reducing BMI-SDS, indicating that certain baseline characteristics can help predict treatment outcomes in pediatric obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatic complaints and social competence predict success in childhood overweight treatment. de Niet, J., Timman, R., Rokx, C., et al.[2018]

Very low-energy diet (VLED) programs are effective for weight loss in children and adolescents with obesity, showing a mean weight loss of 10.1 kg after interventions lasting 3 to 20 weeks, based on a meta-analysis of 20 studies.

While VLED programs significantly improve weight-related outcomes, the existing literature lacks sufficient data on safety and adverse events, highlighting the need for future studies to monitor these aspects and provide long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Andela, S., Burrows, TL., Baur, LA., et al.[2020]

In a study involving 686 obese children aged 7-13, inpatient lifestyle treatment led to a significant short-term decrease in BMI-SDS, but long-term weight maintenance results were similar regardless of whether parents received additional cognitive-behavioral training or just written information.

Both groups showed improvements in quality of life, healthy food intake, and exercise, indicating that while inpatient treatment is effective, the inclusion of parent training did not enhance long-term outcomes for weight maintenance or psychosocial well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training. Warschburger, P., Kroeller, K., Haerting, J., et al.[2019]

In a study of 568 children and adolescents with severe obesity, 73% attended a one-year follow-up, showing a moderate mean reduction in key weight measures, including BMI and waist circumference, indicating that lifestyle interventions can be effective in this population.

About 65% of participants achieved a reduction in their percentage overweight, with 17% moving from severe obesity to obesity, highlighting that while the interventions had positive outcomes, individual responses varied significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for children and adolescents with severe obesity - results after one year. Skodvin, VA., Lekhal, S., Kommedal, KG., et al.[2021]

Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.

While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]

A 24-month combined dietary, behavioral, and physical activity intervention led to a significant improvement in body composition among 196 adolescents with obesity, with 58.2% achieving a notable reduction in BMI z-scores.

Both boys and girls showed significant decreases in body fat and fat mass index, while height and fat-free mass index increased, indicating that the intervention effectively reduced fat without hindering growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the application of a prolonged combined intervention on body composition in adolescents with obesity. Durá-Travé, T., Gallinas-Victoriano, F., Urretavizcaya-Martinez, M., et al.[2021]

The stage-based lifestyle modification intervention for obese children (ages 7-11) was effective in managing weight, as evidenced by a significant decrease in BMI-for-age z scores in the intervention group compared to the control group, which showed no change.

Children in the intervention group also significantly increased their physical activity levels, while the control group experienced a decrease, highlighting the positive impact of structured lifestyle modifications on physical activity in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a stage-based lifestyle modification intervention for obese children. Md Yusop, NB., Mohd Shariff, Z., Hwu, TT., et al.[2018]

In a study involving 64 children aged 9 to 13 with obesity, two primary care lifestyle treatment programs significantly reduced body mass index (BMI) compared to a non-intervention group, demonstrating the effectiveness of lifestyle interventions for childhood obesity.

The addition of physiotherapist-led sessions did not enhance the outcomes compared to nurse-led sessions, indicating that the type of facilitator may not be as crucial as the lifestyle intervention itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of lifestyle treatment in primary care for children with obesity. Mårild, S., Gronowitz, E., Forsell, C., et al.[2013]

Childhood obesity is a serious issue that requires aggressive treatment due to its long-term psychological, social, and medical consequences.

Behavior modification programs have shown more promise in effectively addressing childhood obesity compared to traditional methods like starvation or appetite suppressants, focusing on nutrition, exercise, and family support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confronting obesity in children: behavioral and psychological factors. Brownell, KD., Wadden, TA.[2019]

Current behavioral treatments for childhood and adolescent obesity can achieve long-term weight control in about one-third of participants, highlighting the need for effective strategies.

Successful treatment components include group formats with individualized counseling, parent involvement, frequent sessions, and a focus on creating supportive home environments, but further research is needed to optimize these approaches for sustained weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural treatment of childhood and adolescent obesity. Robinson, TN.[2022]

Citations

1. pcori.org pcori.org/research-results/2023/comparing-effectiveness-intensive-health-behavior-and-lifestyle-treatment-interventions-among-children-obesity

Comparing the Effectiveness of Intensive Health Behavior ... This study compares the effectiveness of five different doses of intensive health behavior and lifestyle treatment among children with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37314275/

Family-Based Behavioral Treatment for Childhood Obesity ... At 24 months, children receiving family-based treatment had better weight outcomes than those receiving usual care based on the difference in ...

3. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2805906

Family-Based Behavioral Treatment for Childhood Obesity ... At 24 months, children receiving family-based treatment had better weight outcomes than those receiving usual care based on the difference in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06654323

Dose Intensity of Behavioral Interventions for Childhood ... The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4504253/

Family-Based Interventions Targeting Childhood Obesity To date, there is preliminary evidence suggesting that family-based interventions targeting childhood obesity are successful in producing weight loss in the ...

7. academic.oup.com academic.oup.com/jcem/article/93/12/4606/2627263?login=false

Behavioral Interventions to Prevent Childhood Obesity Conclusion: Pediatric obesity prevention programs caused small changes in target behaviors and no significant effect on BMI compared with control. Trials ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2023.2251164

Evidence Base Update on Behavioral Treatments for ... This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.