TrialGlobe

Clinical trial

FIT Families Multicomponent Obesity Intervention for African American Adolescents

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04974554

Active, not recruitingNot applicableInterventional

What this study is about

Obesity is one of the most prevalent medical problems facing children and adolescents today, particularly among African American adolescents where the rate is alarmingly high. This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to meet the unique needs of African American adolescents with obesity and their caregivers, against a credible attention control condition. This study has considerable public health relevance because it is delivered by Community Health Workers, maximizing the potential for the intervention to be sustained, and may reduce obesity-related health problems for a vulnerable population of adolescents.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Childhood, Metabolic Syndrome

Full registry criteria

Inclusion Criteria: 1. adolescents (ages 12-17) self-identifying as AA, 2. BMI≥95th percentile for age and gender 3. primary caregiver who is either overweight (BMI 25.0 to 29.9) or obese (BMI≥30) and willing to participate in treatment 4. adolescent residing primarily with the primary caregiver within 30 miles of the MUSC, and 5) adolescent and caregiver obtain PA clearance from a health care provider (see Protection of Human Subjects). Exclusion Criteria: 1. obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics); 2. secondary to a chronic condition (e.g., Down syndrome, Prader-Willi syndrome, Cushing's syndrome). Exclusion criteria that apply to both adolescents and caregivers are: 1. pregnancy, 2. thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal 3. serious cognitive impairment (e.g., inability to complete questionnaires)

Treatments and study arms

FIT

Behavioral

FIT Families is a home-based intervention that works with youth and caregivers to lose weight and improve their health. The intervention lasts 6 months. Sessions are held twice a week for the first 3 months and then once a week for the second 3 months. These sessions will take place in home with a community health worker. In addition, participants will have the opportunity to earn prizes for completing certain intervention related tasks.

Home-Based Family Support

Behavioral

Home-Based Family Support Group will receive six months of weekly family counseling in the home. The weekly visits have 3 goals: 1) provide basic education in nutrition and physical recommendations for adolescent and adult obesity; 2) assess and monitor weight, physical activity, and diet via logs; and 3) offer opportunities to discuss barriers they identify to adherence to weight loss recommendations. The HBFS CHW will also address non-weight related problems such as peer or family relationship problems during the visits.

Primary outcomes

Percent of body fatBaseline

Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

Percent of body fat3-month mid-treatment

Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

Percent of body fat6-month end of treatment

Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

Percent of body fat12-month follow-up

Percent of body fat is measured using bioelectrical impedance analysis (BIA). In BIA measurement, a very weak electronic current is passed through the body by means of four electrodes placed on the dorsal surface of the hand and foot

HeightBaseline

Height in meters will be obtained using a portable stadiometer.

Height3-month mid-treatment

Height in meters will be obtained using a portable stadiometer.

Height6-month end of treatment

Height in meters will be obtained using a portable stadiometer.

Height12-month follow-up

Height in meters will be obtained using a portable stadiometer.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Division of Global and Community Health🇺🇸 Charleston, South Carolina, United States
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