Family-Based Obesity Intervention for Childhood Obesity
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Medical University of South Carolina
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests the FIT Families program, which helps African American teens and their families adopt healthier habits through regular visits, motivational talks, and practical skills training. It targets obese African American adolescents aged 12-17 because they have high rates of obesity and related health issues. The program aims to reduce obesity by encouraging healthy behaviors and providing support at home. The FIT Families program integrates cultural tailoring, positive parenting, and motivational strategies to help African American adolescents reduce obesity.
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.
What data supports the idea that Family-Based Obesity Intervention for Childhood Obesity is an effective treatment?
The available research shows mixed results regarding the effectiveness of Family-Based Obesity Intervention for Childhood Obesity. One study found that a family-oriented intervention program did not have a significant effect compared to no intervention. However, another study suggests that family-based approaches can be effective in improving overweight or obesity in children. This indicates that while some family-based interventions may not show significant results, others have been reported to be beneficial. Therefore, the effectiveness of these interventions might depend on specific program details and implementation.
12345What safety data is available for family-based obesity interventions for children?
The research provided does not specifically mention safety data for the family-based obesity interventions under different names. However, the studies generally report positive outcomes such as weight loss and improved health metrics in children and parents, suggesting these interventions are beneficial. No adverse effects or safety concerns are highlighted in the abstracts, indicating that these programs may be safe, but specific safety data is not detailed in the provided research.
36789Is the FIT Families Multicomponent Obesity Intervention a promising treatment for childhood obesity?
Yes, the FIT Families Multicomponent Obesity Intervention is a promising treatment for childhood obesity. Family-based approaches, like this one, have been shown to be effective in improving overweight or obesity in children by involving parents actively in the treatment process.
1351011Eligibility Criteria
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.
+2 more
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.
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: FIT FamiliesExperimental Treatment1 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 SupportActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Division of Global and Community HealthCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
Florida State UniversityCollaborator
Wayne State UniversityCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Family-based interventions for pediatric obesity: methodological and conceptual challenges from family psychology. [2006]Family-based interventions for pediatric obesity are defined by active parent involvement in treatment. In the current review the authors examine 31 family-based interventions with published outcome data and distinguish 4 categories of family-based interventions: (a) Target a narrow range of parent behaviors related to eating/exercise and assess change only in terms of child eating, exercise, or weight; (b) target a similarly narrow range of parent behaviors but nevertheless assess program-related changes in general parenting skills or family functioning; (c) target a broad range of parent behaviors related to general parenting and family functioning but do not assess program-related changes in these areas; and (d) target general parenting or family functioning and also assess program-related changes in these areas. The authors highlight methodological and conceptual challenges facing researchers in this area and argue for an even broader family focus in family-based interventions for pediatric obesity.
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. [2021]To describe nurses' experiences of a child-centred family guided intervention of obesity tested within the child health services targeting children identified with overweight and their caregivers.
A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention. [2021]To examine the effect of a family-oriented multidisciplinary intervention programme to curtail weight increase in young children with obesity.
BMI changes in children and adolescents attending a specialized childhood obesity center: a cohort study. [2021]Multidisciplinary group therapies for obese children and adolescents are effective but difficult to implement. There is a crucial need to evaluate simpler management programs that target the obese child and his family. This study aimed to determine changes in body mass indexes (BMI) after individual family-based obesity intervention with a pediatrician in a specialized obesity center for child and adolescent.
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). [2022]Family-based approaches have been reported to be effective in improving overweight or obesity in children.
Pilot of "Families for Health": community-based family intervention for obesity. [2008]To develop and evaluate "Families for Health", a new community based family intervention for childhood obesity.
Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. [2019]Children that are classified as obese (body mass index (BMI) > 95th percentile for age and sex, Centers for Disease Control and Prevention) have an increased risk for metabolic and cardiovascular complications. Family based programs that focus on physical activity (PA) and healthy eating are recommended for treatment of pediatric obesity. The purpose of the current study is to determine the outcomes of Building Healthy Families (BHF), a family-based pediatric weight loss treatment program composed of nutrition, physical activity and behavioral modification strategies. In addition, mediating variables that are associated with weight loss in children, in order to enhance the retention and success of this program will be identified. Twenty-two obese (>95th percentile BMI) children (age: 9.94 ± 1.58 yrs) volunteered to participate. Children and their parents (20 moms, 20 dads, 68% obese; BMI > 30 kg·m-2) participated in weekly nutrition education, family lifestyle PA, and one-on-one meetings with a behavioral psychologist. Overall, child participants lost an average of 2.3 ± 2.0 kg of body mass in 12 weeks while parents lost 6.4 ± 4.3 kg of their body mass. There was a significant inverse association between percentage of program goals met and weight loss (r = - 0.67, p < 0.05). Decreases in the child participants intake of high fat, high calorie foods significantly predicted weight change (R2=0.98, p<0.05). In conclusion, family based pediatric obesity programs may offer significant benefits and lead to healthier lifestyles for obese children and their parents.
Service evaluation of the GOALS family-based childhood obesity treatment intervention during the first 3 years of implementation. [2022]To evaluate the impact of the GOALS (Getting Our Active Lifestyles Started) family-based childhood obesity treatment intervention during the first 3 years of implementation.
Two-year follow-up of the 'Families for Health' programme for the treatment of childhood obesity. [2012]The high prevalence of obesity in children in the UK warrants continuing public health attention. 'Families for Health' is a family-based group programme for the treatment of childhood obesity. Significant improvements in body mass index (BMI) z-score (-0.21, 95% CI: -0.35 to -0.07, P = 0.007) and other health outcomes were seen in children at a 9-month follow-up.
Treatment of childhood obesity in obese families. [2020]Parental obesity reduces the likelihood of a multidisciplinary childhood obesity program to succeed, suggesting that special family-based interventions should be constructed for obese children from obese families.
A randomized trial of multiple interventions for childhood obesity in China. [2015]Family- and school-based interventions for childhood obesity have been widely applied; however, the prevalence of childhood obesity remains high. The purpose of this RCT is to evaluate the effectiveness of a family-individual-school-based comprehensive intervention model.