Clinical trial NCT04974554: FIT Families Multicomponent Obesity Intervention for African American Adolescents
Official title: Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step from the ORBIT Initiative
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Metabolic Syndrome
Keywords: obesity, African American adolescents
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Florida State University
name: Wayne State University
First posted: 2021-07-23
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study follows a 2 (condition: FIT Families \[FIT\], and HBFS x 4 (time: baseline \[T1\], 3-month mid-treatment \[T2\], 6-month end of treatment \[T3\], and 12-months follow-up \[T4\]), with random assignment of 180 caregivers/youths to one of the two treatment conditions. Repeated measures of caregiver and youth percent overweight (primary outcome) and physical activity (secondary outcome) will be collected at baseline (T1), and each of the 3 post-randomization time points (T2-T4).
Primary purpose: TREATMENT

Brief 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.

Detailed description: The alarming rates of obesity among children and adults, particularly among ethnic minorities, has been identified by the National Institutes of Health as one of the most serious public health challenges facing our nation in the 21st century. South Carolina (SC), part of the "Stroke Belt," has the 3rd highest obesity rate among US children at 39.2% and the 12th highest obesity rate among US adults at 32.3%. Unfortunately, African Americans in SC are disproportionately more likely to be overweight or obese (75.7% of adults, 40% of children), which places them at considerable high-risk for obesity-related diseases such as asthma, Type 2 diabetes, cardiovascular disease, hypertension, stroke, and some forms of cancer. This public health challenge is compounded by the lack of available intervention strategies specially tailored to meet the unique needs of ethnic minorities. This R01 randomized clinical trial, informed by the results from a recently completed NHLBI/NICHD center grant ("FIT Families Project," U01HL097889; PI-Naar) that followed the National Heart, Lung, and Blood Institute, Obesity Related Behavioral Intervention Trials (ORBIT) model for developing behavioral interventions, will examine the efficacy of FIT Families compared to a credible attention control condition. Each of four evidence-based behavioral components of FIT Families (home-based services, contingency management, motivational interviewing, cognitive behavioral skills training) were culturally tailored and optimized through a proof of concept sequential multiple randomized trial that produced weight loss among African American adolescents, a large and understudied population. One hundred and eighty obese African American adolescents aged 12-17 and their primary caregiver will be randomly assigned to one of two treatment conditions: 1) FIT Families or 2) Home-Based Family Support (HBFS) attention control condition. It is predicted that FIT Families will lead to greater reductions in adolescent and caregiver percent overweight, and increases in physical activity and the use of evidence-based weight management behaviors (self-monitoring of diet and exercise). If effective, FIT Families, which was carefully developed and adapted through successive Phases of ORBIT, has the potential to reduce disparities in obesity-related diseases (cardiovascular and metabolic) by addressing multiple risk factors among African American families and their adolescent children. Thus, this project has high significance in terms of potential public health impact and reduction in obesity related healthcare costs.

Eligibility 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)

Primary outcomes:
measure: Percent of body fat
timeFrame: Baseline
measure: Percent of body fat
timeFrame: 3-month mid-treatment
measure: Percent of body fat
timeFrame: 6-month end of treatment
measure: Percent of body fat
timeFrame: 12-month follow-up
measure: Height
timeFrame: Baseline
measure: Height
timeFrame: 3-month mid-treatment
measure: Height
timeFrame: 6-month end of treatment
measure: Height
timeFrame: 12-month follow-up
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: 3-month mid-treatment
measure: Weight
timeFrame: 6-month mid-treatment
measure: Weight
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Percent overweight
timeFrame: Baseline
measure: Percent overweight
timeFrame: 3 month mid-treatment
measure: Percent overweight
timeFrame: 6 month end of treatment
measure: Percent overweight
timeFrame: 12 month follow-up
measure: Physical activity
timeFrame: baseline
measure: Physical activity
timeFrame: 3-month mid-treatment
measure: Physical activity
timeFrame: 6-month end of treatment
measure: Physical activity
timeFrame: 12-month follow-up
measure: Self-monitoring of physical activity (PA)
timeFrame: Daily for six months during treatment
measure: Self-monitoring of Dietary Intake
timeFrame: Daily for six months during treatment
measure: Symptoms of Metabolic Syndrome
timeFrame: Baseline
measure: Symptoms of Metabolic Syndrome
timeFrame: Baseline
measure: Symptoms of Metabolic Syndrome
timeFrame: 3-month mid-treatment
measure: Symptoms of Metabolic Syndrome
timeFrame: 3-month mid-treatment
measure: Symptoms of Metabolic Syndrome
timeFrame: 6-month end of treatment
measure: Symptoms of Metabolic Syndrome
timeFrame: 6-month end of treatment
measure: Symptoms of Metabolic Syndrome
timeFrame: 12-month follow-up
measure: Symptoms of Metabolic Syndrome
timeFrame: 12-month follow-up
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline
measure: Hemoglobin A1c (HbA1c)
timeFrame: 3-month mid-treatment
measure: Hemoglobin A1c (HbA1c)
timeFrame: 6-month end of treatment
measure: Hemoglobin A1c (HbA1c)
timeFrame: 12-month follow-up
measure: Flanker task
timeFrame: Baseline
measure: Flanker task
timeFrame: 6-month end of treatment
measure: Flanker task
timeFrame: 12-month follow-up
measure: List Sorting test
timeFrame: Baseline
measure: List Sorting test
timeFrame: 6-month end of treatment
measure: List Sorting test
timeFrame: 12-month follow-up
measure: Delayed Reward Discounting Task
timeFrame: Baseline
measure: NEURO-QOL
timeFrame: 6-month end of treatment
measure: Delayed Reward Discounting Task
timeFrame: 6-month end of treatment
measure: Delayed Reward Discounting Task
timeFrame: 12-month follow-up
measure: NEURO-QOL
timeFrame: Baseline
measure: NEURO-QOL
timeFrame: 12-month follow-up
measure: Brief Symptom Inventory
timeFrame: Baseline
measure: Brief Symptom Inventory
timeFrame: 6-month mid-treatment
measure: Brief Symptom Inventory
timeFrame: 12-month end of treatment
measure: PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms
timeFrame: Baseline
measure: PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms
timeFrame: 6-month mid-treatment
measure: PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms
timeFrame: 12-month follow-up
measure: PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms
timeFrame: Baseline
measure: PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms
timeFrame: 6-month end of treatment
measure: PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms
timeFrame: 12-month follow-up
measure: Working Alliance Inventory
timeFrame: Monthly during the six months of treatment.
measure: Service Utilization Questionnaire
timeFrame: Baseline
measure: Service Utilization Questionnaire
timeFrame: 3-month mid-treatment
measure: Service Utilization Questionnaire
timeFrame: 6-month end of treatment
measure: Service Utilization Questionnaire
timeFrame: 12-month follow-up
measure: Parent Adolescent Relationship Questionnaire (PARQ)
timeFrame: Baseline
measure: Parent Adolescent Relationship Questionnaire (PARQ)
timeFrame: 6-month end of treatment
measure: Parent Adolescent Relationship Questionnaire (PARQ)
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Division of Global and Community Health
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Phillippe B Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham PB, Naar S, Roberts JR, Powell J, Ledgerwood DM, Randall J, Lozano BE, Halliday CA, Madisetti M, Ghosh S. Study protocol for clinical trial of the FIT Families multicomponent obesity intervention for African American adolescents and their caregivers: Next step from the ORBIT initiative. BMJ Open. 2024 Feb 13;14(2):e074552. doi: 10.1136/bmjopen-2023-074552.
citation: Cunningham PB, Gilmore J, Naar S, Preston SD, Eubanks CF, Hubig NC, McClendon J, Ghosh S, Ryan-Pettes S. Opening the Black Box of Family-Based Treatments: An Artificial Intelligence Framework to Examine Therapeutic Alliance and Therapist Empathy. Clin Child Fam Psychol Rev. 2023 Dec;26(4):975-993. doi: 10.1007/s10567-023-00451-6. Epub 2023 Sep 7.