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

Trial Summary

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 data supports the effectiveness of the treatment Intensive Behavioral Lifestyle Modification for childhood obesity?

Research shows that lifestyle interventions, which include changes in diet and physical activity, can help reduce weight in children with obesity. Behavioral treatments that involve family participation and focus on long-term lifestyle changes have been effective in managing childhood obesity. ^{1 2 3 4 5}

Is intensive behavioral lifestyle modification safe for children and adolescents with obesity?

While intensive behavioral lifestyle interventions for childhood obesity can lead to positive changes like weight loss and improved health markers, there is limited information on their safety. Some studies mention potential negative effects, such as the development of disordered eating patterns, but more research is needed to fully understand the safety of these interventions. ^{1 6 7 8 9}

How is the Intensive Behavioral Lifestyle Modification treatment different from other treatments for childhood obesity?

Intensive Behavioral Lifestyle Modification is unique because it focuses on changing behaviors related to diet, exercise, and family support, rather than relying on traditional methods like appetite suppressants or strict diets. This approach involves a comprehensive plan that addresses eating habits, physical activity, and psychological factors, making it a more holistic and potentially effective option for managing childhood obesity. ^{1 2 6 10 11}

What is the purpose of this trial?

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 caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and their caregivers receive 16, 19, or 22 hours of IBT. Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months. At the start of the study and again after one year, the research team is measuring the children's body mass index, or BMI. BMI is a measure of a person's body fat based on their height and weight. The team is also looking at the children's: * Diet * Exercise * Sleep * Media use * Quality of life

Research Team

Amanda Staiano, PhD

Principal Investigator

Pennington Biomedical Research Center

William Heerman, MD MPH

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. Norway pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for children and adolescents with severe obesity - results after one year. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of a stage-based lifestyle modification intervention for obese children. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Somatic complaints and social competence predict success in childhood overweight treatment. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Behavioural treatment of childhood and adolescent obesity. [2022]

6. England pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. [2023]

7. England 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effects of the application of a prolonged combined intervention on body composition in adolescents with obesity. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. [2007]

10. England pubmed.ncbi.nlm.nih.gov

A controlled study of lifestyle treatment in primary care for children with obesity. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Confronting obesity in children: behavioral and psychological factors. [2019]