Family-Based Weight Loss Program for Childhood Obesity

Overseen By Justin Moore, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Bmi < 30, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a family-based program designed to help children and their guardians lose weight and develop healthy habits. It emphasizes strategies such as self-monitoring, communication, and support to boost physical activity and improve eating behaviors. The trial includes different groups: one for children in the Brenner FIT program, one for their caregivers, and a combined group where both participate together. Families with an overweight child referred by a doctor, and a caregiver living in the house with a BMI over 30 who can engage in physical activities and follow dietary guidelines, may be a good fit. As an unphased trial, this study offers families the chance to contribute to important research on health and wellness improvement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for participants?

Research has shown that the Brenner FIT program, a family-based clinic, effectively manages childhood obesity and receives positive feedback from participants. This program includes a team of experts, such as pediatricians, dietitians, and counselors, who collaborate to help children and their families adopt healthy lifestyle changes. By focusing on lifestyle changes rather than medication, it maintains a good safety record with fewer side effects.

For the By Design Essentials component, studies indicate that emphasizing healthy eating and physical activity is generally safe for children with obesity. These changes aim for gradual weight loss, helping to avoid negative health effects.

The Dyad Plus program aims to improve self-monitoring, communication, and social support. Although specific safety data is limited, its focus on behavior and lifestyle changes suggests a low risk of side effects.

Overall, these programs use safe, non-invasive methods to promote weight loss and healthy habits in families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on innovative family-based approaches to tackle childhood obesity. The "Co-enrollment" arm takes a unique angle by involving both children and their caregivers, adding elements like joint goal setting and parent/child communication sessions to boost motivation and support. Unlike traditional weight loss programs, which often focus solely on the individual, this method emphasizes family dynamics and home environment, aiming to create lasting healthy habits. Meanwhile, the caregivers' program provides tailored diet and exercise plans to achieve steady weight loss, something not always emphasized in existing family health interventions. By involving a multidisciplinary team, this approach ensures comprehensive support, addressing both physical and behavioral aspects of weight management.

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

Research has shown that the Brenner FIT Standard program, a treatment option in this trial, improves children's weight and family health habits. Families collaborating have successfully managed weight. Another option, the By Design Essentials program, supports caregivers and demonstrates that family support can lead to weight loss. Studies indicate that caregivers can lose significant weight through organized programs. The Dyad Plus approach, also included in this trial, emphasizes tracking progress, positive communication, and support, which are crucial for successful family weight loss. ^{1 3 6 7 8}

Who Is on the Research Team?

Justin Moore

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for families where a child and their caregiver are both looking to lose weight. The caregiver must live with the child, have a BMI over 30, and be able to read and write in English. They should also be fit enough for physical activity and caloric restriction.

Inclusion Criteria

Must be able to read and write English

Eligible for enrollment in Brenner FIT and/or By Design Essentials

My caregiver at home is overweight.

Exclusion Criteria

BMI < 30

Cannot read or write English

You are unable to exercise or follow a restricted diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Brenner FIT standard care, By Design Essentials, or Dyad Plus interventions, including monthly visits and group sessions over 6 months

6 months

Monthly visits (in-person), group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brenner FIT Standard
• By Design Essentials
• Dyad Plus

Trial Overview The study tests Dyad Plus, a program aiming to improve family health by encouraging exercise, healthy eating habits, and weight loss through better self-monitoring, communication, problem-solving skills, and social support.

How Is the Trial Designed?

Group I: Co-enrollment Experimental Treatment 1 Intervention

This condition is for dyads that are co-enrolled in This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.

Group II: Caregivers of Adolescent Participants Experimental Treatment 1 Intervention

Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.

Group III: Adolescent Participants Active Control 1 Intervention

Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a 12-week family-based program called Building Healthy Families, 22 obese children lost an average of 2.3 kg, while their parents lost an average of 6.4 kg, indicating the program's effectiveness in promoting weight loss for both children and parents.

The study found that reducing the intake of high-fat, high-calorie foods was a strong predictor of weight loss in children, highlighting the importance of dietary changes in successful obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]

The CANadian Pediatric Weight management Registry (CANPWR) aims to track changes in weight and health outcomes in 1,600 children aged 2-17 with obesity over three years, focusing on various health metrics and lifestyle factors.

This study will provide valuable insights into the effectiveness of family-based weight management interventions in real-world clinical settings, helping to improve care for children with obesity and inform future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CANadian Pediatric Weight management Registry (CANPWR): study protocol. Morrison, KM., Damanhoury, S., Buchholz, A., et al.[2021]

Parents participating in a commercial weight loss program showed a significant decrease in their body mass index (BMI) after 8 weeks, indicating potential efficacy of such programs for adult weight management.

However, children in the study experienced an increase in their BMI and BMI percentile, suggesting that while parents improved their health behaviors, the impact on children's weight-related health behaviors may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility of parent participation in a commercial weight loss program to improve child body mass index and weight-related health behaviors. Song, M., Lee, CS., Lyons, KS., et al.[2022]

The ProActive Kids Foundation's early intervention program significantly improved body composition in 884 overweight and obese youth aged 5 to 17 over an 8-week period, demonstrating effective weight management strategies.

Involving families in the program, which included education on mental health, nutrition, and physical activity, led to sustainable improvements in weight, body fat, and BMI, highlighting the importance of a supportive environment in tackling pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and Treatment of Pediatric Obesity: A Strategy Involving Children, Adolescents and the Family for Improved Body Composition. Moxley, E., Habtzghi, D., Klinkhamer, N., et al.[2019]

In a study of 75 participants in the Building Healthy Families program, those who achieved the largest reductions in BMI z-scores had high attendance and self-regulation skills, particularly among both children and mothers.

Successful outcomes were linked to mothers achieving clinically meaningful weight loss and children maintaining high attendance rates, suggesting that both parental involvement and self-regulation are crucial for effective obesity treatment in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. Golden, CA., Heelan, KA., Hill, JL., et al.[2022]

The study aims to enhance the existing Brenner Families in Training (Brenner FIT) program for youth obesity by integrating mobile health (mHealth) components, which include tracking tools and educational content, to improve engagement and outcomes.

Eighty youths aged 13-18 with obesity will be randomized to either the standard Brenner FIT program or the enhanced Brenner mFIT program, with outcomes assessed at 3 and 6 months to evaluate acceptability, feasibility, and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study. Moore, JB., Dilley, JR., Singletary, CR., et al.[2020]

The Fit Kids/Fit Families (FKFF) program, a 12-week intervention involving 68 children and their families, led to significant improvements in healthy lifestyle knowledge and attitudes, with 59% of children increasing physical activity and 32% reducing sedentary behavior.

Preliminary results indicate that FKFF effectively reduced body mass index (BMI) and total body circumferences in 81% and 74% of participants, respectively, while also enhancing self-esteem in nearly two-thirds of the children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit Kids/Fit Families: a report on a countywide effort to promote healthy behaviors. Joosse, L., Stearns, M., Anderson, H., et al.[2008]

In a randomized controlled trial involving 72 obese children, family-based behavioral treatment (FBBT) showed no significant difference in BMI reduction compared to a waiting-list control group, indicating that both groups experienced similar improvements in weight.

The treatment group did report significant reductions in systolic blood pressure and improvements in quality of life and eating attitudes, with no adverse effects noted, suggesting that while FBBT may not lead to greater weight loss, it can have positive health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. Croker, H., Viner, RM., Nicholls, D., et al.[2022]

The study evaluates the efficacy of the 'ENTREN-F' program, a family-system-based intervention for managing childhood obesity, involving 8 to 12-year-old children with overweight and obesity, and includes active parental involvement and Cognitive Behavioral Therapy principles.

This randomized controlled trial aims to assess not only weight loss through changes in BMI z-scores but also improvements in children's psychological well-being and family functioning over six months, addressing a significant gap in obesity management literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ENTREN-F family-system based intervention for managing childhood obesity: Study protocol for a randomized controlled trial at primary care. Rojo, M., Lacruz, T., Solano, S., et al.[2022]

In a multicenter randomized controlled trial involving families with at least one overweight parent and a healthy child, changes in the mother's body mass index (BMI) were positively associated with changes in the BMI-for-age Z-scores of both children, indicating that parental weight management can influence children's weight outcomes.

The study highlights the effectiveness of family-based dietary interventions for weight maintenance, suggesting that including parents in these programs can benefit children's weight management, regardless of the child's initial weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of changes in body mass index and metabolic parameters between adults with overweight or obesity and their children in a family-based randomized trial (DiOGenes). Pang, MD., Yilmaz, H., Astrup, A., et al.[2022]

A 2-year camp-based family treatment program for obesity showed a lower increase in BMI for children compared to an outpatient program, but did not result in significant differences in BMI SD scores between the two groups.

Both treatment approaches led to small reductions in parental BMI, but these changes were not significantly different, indicating that neither program was more effective than the other in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Camp-based family treatment of childhood obesity: randomised controlled trial. Benestad, B., Lekhal, S., Småstuen, MC., et al.[2022]

Citations

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Bridging the Gap between Family-Based Treatment and ... As a novel approach to improve the treatment of obese children, Brenner FIT launched quality improvement initiatives to enhance treatment outcomes by ...

2. wakehealth.edu wakehealth.edu/-/media/wakeforest/clinical/files/brenner/brenner-fit-annual-report-2018-2019_digital.pdf

FAMILIES IN TRAINING Brenner FIT has been successful, both in improving the weight status of children, and in improving the health habits of families. Measuring success in weight ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078845/

Protocol for a randomized controlled feasibility study of a ... Brenner FIT is an interdisciplinary, family-based pediatric weight management ... standard care and lead to a larger trial studying weight loss outcome data.

4. wakehealth.edu wakehealth.edu/-/media/wakeforest/clinical/files/brenner/brenner-fit/brenner-fit-2023-annual-report.pdf

Brenner FIT® The American. Academy of Pediatrics released their first-ever Clinical Practice Guidelines for the Evaluation and Treatment of Children and Adolescents with.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876285914003982

Family-Based Obesity Treatment in Children With Disabilities Among children enrolled in weight management, those with CD exhibited similar or better outcomes compared to children without disabilities, particularly ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03811743

NCT03811743 | A Coordinated Parent/Child Dyad Weight ... Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 By Design is ...

7. wakehealth.edu wakehealth.edu/specialty/b/brenner-fit/professional-education/for-professionals

Pediatric Obesity Management: Become the Expert in Your ... Pediatric Obesity Management: Become the Expert in Your Clinic is a self-paced, five-part learning series developed by the multidisciplinary team at Brenner FIT ...

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Attrition in paediatric weight management: A review of the ... Paediatric obesity continues to be one of the most important health issues facing children and families today, and there remains a need for effective ...