Active — Not RecruitingNot Applicable

FIT Families Multicomponent Obesity Intervention for African American Adolescents

United States360 participantsStarted 2021-05-01

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. adolescents (ages 12-17) self-identifying as AA,
✓. BMI≥95th percentile for age and gender
✓. primary caregiver who is either overweight (BMI 25.0 to 29.9) or obese (BMI≥30) and willing to participate in treatment
✓. 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

✕. obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics);
✕. secondary to a chronic condition (e.g., Down syndrome, Prader-Willi syndrome, Cushing's syndrome).
✕. pregnancy,
✕. thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
✕. serious cognitive impairment (e.g., inability to complete questionnaires)

What they're measuring

Percent of body fat

Timeframe: Baseline

Percent of body fat

Timeframe: 3-month mid-treatment

Percent of body fat

Timeframe: 6-month end of treatment

Percent of body fat

Timeframe: 12-month follow-up

Height

Timeframe: Baseline

Height

Timeframe: 3-month mid-treatment

Height

Timeframe: 6-month end of treatment

Height

Timeframe: 12-month follow-up

Weight

Timeframe: Baseline

Trial details

NCT IDNCT04974554

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Obesity, Childhood trials

Plain-language summary

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. adolescents (ages 12-17) self-identifying as AA,
✓. BMI≥95th percentile for age and gender
✓. primary caregiver who is either overweight (BMI 25.0 to 29.9) or obese (BMI≥30) and willing to participate in treatment
✓. 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

✕. obesity secondary to medication use for another medical condition (e.g., steroids, antipsychotics);
✕. secondary to a chronic condition (e.g., Down syndrome, Prader-Willi syndrome, Cushing's syndrome).
✕. pregnancy,
✕. thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
✕. serious cognitive impairment (e.g., inability to complete questionnaires)

What they're measuring

Percent of body fat

Timeframe: Baseline

Percent of body fat

Timeframe: 3-month mid-treatment

Percent of body fat

Timeframe: 6-month end of treatment

Percent of body fat

Timeframe: 12-month follow-up

Height

Timeframe: Baseline

Height

Timeframe: 3-month mid-treatment

Height

Timeframe: 6-month end of treatment

Height

Timeframe: 12-month follow-up

Weight

Timeframe: Baseline