Family-Based Obesity Intervention for Childhood Obesity

Overseen By Phillippe B Cunningham, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Steroids, Antipsychotics

Disqualifiers: Pregnancy, Thought disorder, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a family-based program called FIT Families Multicomponent Obesity Intervention, designed to help African American adolescents address obesity. The program includes activities such as exercise, motivational support, and family counseling, all tailored to the cultural needs of participants. Researchers will compare it to another program that offers supportive family counseling. The study seeks adolescents aged 12-17 who identify as African American, have a body weight in the top 5% for their age and gender, and live with a willing caregiver who is also overweight. Participants must reside within 30 miles of MUSC and have clearance from a healthcare provider to engage in physical activities. As an unphased trial, this study provides a unique opportunity to contribute to research that could shape future obesity interventions for African American adolescents.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if your obesity is due to medication use for another condition, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your obesity is due to medication use for another condition, you may not be eligible to participate.

What prior data suggests that this intervention is safe for adolescents?

Research shows that the FIT Families Multicomponent Obesity Intervention helps African American teenagers with obesity by promoting healthy habits through family counseling, motivational talks, and exercise. Studies have found that family-based programs like this are generally well-received and aim to improve lifestyle habits without major risks.

For the Home-Based Family Support part of the program, past research highlights the benefits of involving the whole family in managing childhood obesity. These home-based methods have effectively aided weight management without serious side effects.

Both parts of the program focus on safety by encouraging behavior changes and involving the family. This approach reduces the chance of harm, making it a safe option for helping teenagers manage obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FIT Families Multicomponent Obesity Intervention because it offers a comprehensive, family-centered approach that differs from standard treatments for childhood obesity, like individual diet plans and exercise programs. This intervention uniquely combines home-based service delivery, Motivational Interviewing to boost intrinsic motivation, Cognitive Behavioral Skills Training for developing healthy habits, and supervised physical activity, all wrapped into a program delivered by Community Health Workers. Additionally, the use of Contingency Management introduces extrinsic motivation, which can be a game-changer in maintaining long-term lifestyle changes. This multicomponent strategy addresses not just the child's behavior but also involves the family, aiming for more sustainable outcomes.

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

Studies have shown that programs involving the whole family can effectively reduce childhood obesity. In this trial, participants will join one of two programs. Research indicates that when parents participate, as in the Home-Based Family Support program, children are more likely to lose weight. These programs often lead to better weight outcomes and other positive health changes. Additionally, the FIT Families program, another approach in this trial, is culturally relevant and uses various support methods, such as motivational interviewing and encouraging physical activity. Early evidence suggests that these strategies are promising for reducing obesity among African American adolescents. Overall, both approaches show potential for helping families manage childhood obesity effectively. ^{1 2 4 6 7}

Who Is on the Research Team?

Phillippe B Cunningham, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for African American adolescents aged 12-17 with obesity, living within 30 miles of the MUSC. They must have a BMI in the 95th percentile or higher and a primary caregiver who is overweight or obese willing to participate. Both must get physical activity clearance from a healthcare provider. Those with obesity due to chronic conditions, serious cognitive impairments, thought disorders, or medication-induced obesity cannot join.

Inclusion Criteria

Adolescent and caregiver obtain PA clearance from a health care provider (see Protection of Human Subjects)

I am between 12 and 17 years old and identify as African American.

I am a teenager living mostly with my main caregiver within 30 miles of MUSC.

Exclusion Criteria

My obesity is due to a chronic condition like Down syndrome.

Pregnancy

I have difficulty understanding or completing questionnaires due to cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FIT Families intervention or Home-Based Family Support for 6 months

6 months

Twice weekly for the first three months, weekly for the second three months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• FIT Families Multicomponent Obesity Intervention
• Home-Based Family Support

Trial Overview The study tests 'FIT Families', a culturally tailored behavioral intervention aimed at reducing obesity in African American teens and their caregivers against an attention control condition. It's delivered by Community Health Workers which could make it sustainable if effective.

How Is the Trial Designed?

Group I: FIT Families Experimental Treatment 1 Intervention

1\. FIT Families is a 6 month comprehensive multicomponent family-based behavioral intervention delivered by Community Health Workers (CHWs). FIT Families integrates home-based service delivery, Motivational Interviewing (MI; intrinsic motivation), Cognitive Behavior Skills Treatment (CBST; skills acquisition), supervised physical activity (PA), and Contingency Management (CM; extrinsic motivation). Sessions occur twice weekly for the first three months, and weekly for the second three months.

Group II: Home-Based Family Support Active Control 1 Intervention

2\. Home-based Family Support (HBFS). Adolescents and their primary caregiver randomly assigned to HBFS will receive 6 months of weekly, home-based, client-centered, non-directive supportive family counseling.

FIT Families Multicomponent Obesity Intervention is already approved in United States for the following indications:

Approved in United States as FIT Families for:

• Obesity in African American adolescents

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Nurses reported that the child-centred health dialogue (CCHD) intervention for addressing childhood overweight was emotionally challenging, but the training they received improved their ability to engage families in discussions about healthy lifestyles.

Despite the emotional difficulties, the structured training provided nurses with tools and support, enhancing their professionalism and effectiveness in conducting health dialogues with children and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A challenging balancing act to engage children and their families in a healthy lifestyle - Nurses' experiences of child-centred health dialogue in child health services in Sweden. Castor, C., Derwig, M., Borg, SJ., et al.[2021]

A family-based obesity intervention led by pediatricians resulted in a significant decrease in BMI z-scores for nearly half of the 283 children studied, particularly benefiting younger and more severely obese patients.

The study highlights that additional psychological support can enhance weight reduction outcomes, especially for children aged 8 to 11 years, suggesting a multi-faceted approach may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BMI changes in children and adolescents attending a specialized childhood obesity center: a cohort study. Maggio, AB., Saunders Gasser, C., Gal-Duding, C., et al.[2021]

A 3-month family-based intervention for obese children from obese families resulted in significant weight loss and improved BMI percentiles compared to a control group, highlighting the efficacy of targeted interventions in this population.

The intervention also successfully reduced screen time and improved fitness levels, indicating that a combined approach addressing dietary, behavioral, and physical activity factors can lead to positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. Nemet, D., Barzilay-Teeni, N., Eliakim, A.[2020]

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 'Families for Health' program led to a significant reduction in BMI z-score of -0.23 at the 2-year follow-up, indicating sustained effectiveness in managing childhood obesity among the 27 participants.

Improvements were also noted in children's quality of life and eating habits, with 42% of children achieving a clinically significant reduction in BMI z-score, suggesting the program's potential for long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year follow-up of the 'Families for Health' programme for the treatment of childhood obesity. Robertson, W., Thorogood, M., Inglis, N., et al.[2012]

The GOALS intervention led to a significant reduction in child BMI z-score by 0.07, which was maintained 12 months after the program, indicating its effectiveness in addressing childhood obesity.

Parents reported positive changes in family physical activity and dietary behaviors, suggesting that the program successfully promoted a whole-family approach to lifestyle changes, although there were no significant changes in parent BMI or child self-perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service evaluation of the GOALS family-based childhood obesity treatment intervention during the first 3 years of implementation. Watson, PM., Dugdill, L., Pickering, K., et al.[2022]

A comprehensive family-individual-school-based intervention model significantly reduced the prevalence of overweight and obesity among first-grade students in Shanghai, with a decline from 28.92% to 24.77% over three years in the intervention group.

The intervention group showed lower odds of developing obesity and decreased average BMI z-scores compared to the control group, highlighting the effectiveness of this approach in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of multiple interventions for childhood obesity in China. Cao, ZJ., Wang, SM., Chen, Y.[2015]

The review analyzed 31 family-based interventions for pediatric obesity, categorizing them into four types based on their focus on parent behaviors and assessment of child outcomes.

The authors suggest that current interventions could benefit from a broader focus on family dynamics and parenting skills, as this may enhance the effectiveness of obesity treatment in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based interventions for pediatric obesity: methodological and conceptual challenges from family psychology. Kitzmann, KM., Beech, BM.[2006]

A family-oriented multidisciplinary intervention program aimed at reducing weight gain in young children with obesity did not result in any significant change in BMI standard deviation scores (SDS) after three years, with both intervention and control groups showing a median decrease of 0.19.

The study involved 31 families in the intervention group and 33 in the control group, with initial BMI SDS values indicating that the program did not effectively curtail weight increase, regardless of social or behavioral factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention. Donkor, HM., Grundt, JH., Júlíusson, PB., et al.[2021]

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]

The 'Families for Health' program, a 12-week community-based intervention for childhood obesity, led to a significant reduction in BMI z scores among participants, with a decrease of -0.18 at 3 months and -0.21 at 9 months, indicating its potential efficacy.

Participants also reported improvements in children's quality of life, lifestyle habits, and parent-child relationships, suggesting that the program positively impacted both physical health and family dynamics, although some areas like self-esteem and fruit/vegetable consumption did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot of "Families for Health": community-based family intervention for obesity. Robertson, W., Friede, T., Blissett, J., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10868253/

Study protocol for clinical trial of the FIT Families ... This study will test the effectiveness of FIT Families (FIT), a multicomponent family-based behavioural intervention, against a credible attention control ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4450135/

An Overview of the Families Improving Together (FIT) for ... The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11–16 years.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04974554

FIT Families Multicomponent Obesity Intervention for ... This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to meet the unique ...

4. withpower.com withpower.com/trial/phase-metabolic-syndrome-9-2021-11e26

Family-Based Obesity Intervention for Childhood Obesity The program aims to reduce obesity by encouraging healthy behaviors and providing support at home. The FIT Families program integrates cultural tailoring, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/osp4.498

The Families Improving Health Together (FIT) Program ... This pilot study suggests that an integrated multispecialty/interdisciplinary approach to children with obesity improves patient retention.

6. cochranelibrary.com cochranelibrary.com/central/doi/10.1002/central/CN-02296945/full

FIT Families Multicomponent Obesity Intervention for ... https://clinicaltrials.gov/ct2/show/NCT04974554, 2021 | added to CENTRAL: 31 August 2021 | 2021 Issue 08. Sourced from: CT.gov. Links: ClinicalTrials.gov.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04974554/fit-families-multicomponent-obesity-intervention-for-african-american-adolescents

FIT Families Multicomponent Obesity Intervention for ... This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to ...