Family-Based Treatment for Childhood Obesity

Overseen By Hollie Raynor, PhD RD LDN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Must not be taking: Weight loss medications

Disqualifiers: Heart condition, Psychiatric diseases, Bariatric surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new family-based approach to managing childhood obesity affects children's body mass index (BMI) over 18 months. Participants will split into two groups: one will follow a standard family-based behavioral treatment (FBT) plan, while the other will focus additionally on reducing the variety of high-energy-dense foods consumed (FBT+Variety). Researchers will assess changes in dietary habits, activity levels, and weight. This trial suits children aged 8 to 12 who are above the 85th percentile for BMI and have an adult caregiver willing to participate. As an unphased trial, this study allows families to contribute to innovative research that could shape future obesity treatments.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using prescription medications that could limit exercise, you will need written consent from a physician to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that family-based treatments (FBT) for childhood obesity are generally safe. In various studies, children in these programs achieved better weight outcomes without major side effects. This includes both regular FBT and a version that limits food variety, known as FBT+Variety.

For FBT, evidence indicates that children lost weight over time, with no serious negative effects reported. This method is well-accepted and helps families make healthy lifestyle changes together.

The FBT+Variety approach, which reduces the variety of high-calorie foods, also appears safe. One study found that children in this group lost more weight without any reports of harm.

Overall, these treatments focus on changing behavior and diet, which are non-invasive and considered safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood obesity because they offer a family-centered approach that emphasizes behavioral changes rather than relying solely on medication or surgery. The FBT (Family-Based Treatment) uses a Traffic Light Diet that simplifies meal planning by categorizing foods into RED, YELLOW, and GREEN, making it easier for families to adopt healthier eating habits. The FBT+Variety treatment builds on this by helping families identify specific RED foods to limit, which can streamline decision-making and encourage consistency in dietary choices. Both methods also incorporate daily physical activity goals for both children and adults, making them holistic approaches to tackling obesity.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research shows that family-based behavioral treatment (FBT) for childhood obesity works well. Studies indicate that children in FBT achieve better weight outcomes than those receiving standard care. Long-term data reveal that many children in FBT no longer have obesity after ten years.

In this trial, participants will join one of two treatment arms. One arm, the FBT+Variety approach, limits the variety of high-calorie foods and looks promising. Early studies found that this method led to greater reductions in child obesity levels compared to regular FBT. Overall, both treatments in this trial effectively manage childhood obesity by involving the family and making dietary changes. ^{1 3 4 6 7}

Who Is on the Research Team?

Hollie Raynor, PhD RD LDN

Principal Investigator

University of Tennessee Knoxville

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with a BMI over the 85th percentile and an adult caregiver in the household with a BMI over 25 kg/m2. Both must live together full-time, be able to walk two blocks without stopping, not have had or plan bariatric surgery within certain time frames, and not be pregnant or planning pregnancy.

Inclusion Criteria

BMI > 85th percentile

> 85th percentile BMI

I have an adult caregiver with a BMI over 25 willing to attend treatment meetings.

Exclusion Criteria

Do not have reliable internet access

Child or adult caregiver report allergies to lemon or lime juice (used in habituation measures)

Child is not able to read at a third-grade reading level

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive family-based behavioral obesity treatment (FBT) or FBT+Variety for 18 months, focusing on dietary intake, habituation, and physical activity

18 months

Assessments at 0, 6, 12, and 18 months

Follow-up

Participants are monitored for changes in BMI, dietary intake, and habituation after the treatment phase

6 months

What Are the Treatments Tested in This Trial?

Interventions

• FBT
• FBT+Variety

Trial Overview The study tests if limiting high-energy-dense food variety affects body mass index (BMI) in kids during an 18-month family-based treatment (FBT). It compares standard FBT against FBT plus varied diet interventions, measuring changes in weight, eating habits, and physical activity.

How Is the Trial Designed?

Group I: FBT+Variety Experimental Treatment 1 Intervention

The FBT+Variety condition will receive FBT along with a limited variety prescription. In this prescription families will identify two RED foods, a dinner entree and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED entrees and snack foods.

Group II: FBT (family-based behavioral treatment) Active Control 1 Intervention

This condition will be prescribed the Traffic Light Diet (1000-1500 kcal/day, \< 2 servings/day of RED \[non-nutrient-dense, energy-dense\] foods) and a \> 60 min/day of MVPA prescription for children and \> 30 min/day of MVPA for adults at least 5 days/week. FBT will receive a family-based, behavioral intervention to assist the targeted child and a participating adult caregiver with making changes in energy balance behaviors.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Memphis

Collaborator

Trials

73

Recruited

12,000+

Citations

1. 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 ...

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424001459

A randomized controlled trial examining general parenting ... This clinical trial tests the effect of parenting training on childhood obesity. Results will inform the development of more effective treatments.

4. 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.

5. publications.aap.org publications.aap.org/pediatrics/article/155/2/e2024066561/200679/Guided-Self-Help-vs-Group-Treatment-for-Children

Guided Self-Help vs Group Treatment for Children With ... Ten-year FBT follow-up data show that one-third of children who participate in FBT no longer have obesity.13,14 FBT is provided in weekly group ...

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

Family-Based Interventions Targeting Childhood Obesity Of these, 50% showed statistically significant child weight loss change at 6-month, 1-year and 2-year follow-up, although effect sizes were more modest (small ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9664376/

Implementing family-based behavioral treatment in the ... The primary hypothesis is that children randomized to FBT + UC will show greater reduction in percent over 50th percentile BMI change in comparison to children ...