Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step From the ORBIT Initiative
Overview
- Phase
- Not Applicable
- Intervention
- FIT
- Conditions
- Obesity, Childhood
- Sponsor
- Medical University of South Carolina
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Percent of body fat
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Mohan Madisetti
Professor
Medical University of South Carolina
Eligibility Criteria
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).
- •Exclusion criteria that apply to both adolescents and caregivers are:
- •thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
- •serious cognitive impairment (e.g., inability to complete questionnaires)
Arms & Interventions
FIT Families
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.
Intervention: FIT
Home-Based Family Support
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.
Intervention: Home-Based Family Support
Outcomes
Primary Outcomes
Percent of body fat
Time Frame: 12-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
Weight
Time Frame: 12-month follow-up
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
Height
Time Frame: 12-month follow-up
Height in meters will be obtained using a portable stadiometer.
Percent of body fat
Time Frame: Baseline
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 fat
Time Frame: 3-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 fat
Time Frame: 6-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
Height
Time Frame: Baseline
Height in meters will be obtained using a portable stadiometer.
Height
Time Frame: 3-month mid-treatment
Height in meters will be obtained using a portable stadiometer.
Height
Time Frame: 6-month end of treatment
Height in meters will be obtained using a portable stadiometer.
Weight
Time Frame: Baseline
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
Weight
Time Frame: 3-month mid-treatment
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
Weight
Time Frame: 6-month mid-treatment
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
Secondary Outcomes
- Service Utilization Questionnaire(12-month follow-up)
- Percent overweight(12 month follow-up)
- PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms(12-month follow-up)
- Physical activity(12-month follow-up)
- Hemoglobin A1c (HbA1c)(12-month follow-up)
- Flanker task(12-month follow-up)
- List Sorting test(12-month follow-up)
- NEURO-QOL(12-month follow-up)
- Brief Symptom Inventory(12-month end of treatment)
- Working Alliance Inventory(Monthly during the six months of treatment.)
- Self-monitoring of physical activity (PA)(Daily for six months during treatment)
- Self-monitoring of Dietary Intake(Daily for six months during treatment)
- Delayed Reward Discounting Task(12-month follow-up)
- PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms(12-month follow-up)
- Parent Adolescent Relationship Questionnaire (PARQ)(12-month follow-up)
- Symptoms of Metabolic Syndrome(12-month follow-up)
- Percent overweight(Baseline)
- Percent overweight(3 month mid-treatment)
- Percent overweight(6 month end of treatment)
- Physical activity(baseline)
- Physical activity(3-month mid-treatment)
- Physical activity(6-month end of treatment)
- Symptoms of Metabolic Syndrome(Baseline)
- Symptoms of Metabolic Syndrome(3-month mid-treatment)
- Symptoms of Metabolic Syndrome(6-month end of treatment)
- Hemoglobin A1c (HbA1c)(Baseline)
- Hemoglobin A1c (HbA1c)(3-month mid-treatment)
- Hemoglobin A1c (HbA1c)(6-month end of treatment)
- Flanker task(Baseline)
- Flanker task(6-month end of treatment)
- List Sorting test(Baseline)
- List Sorting test(6-month end of treatment)
- Delayed Reward Discounting Task(Baseline)
- NEURO-QOL(6-month end of treatment)
- Delayed Reward Discounting Task(6-month end of treatment)
- NEURO-QOL(Baseline)
- Brief Symptom Inventory(Baseline)
- Brief Symptom Inventory(6-month mid-treatment)
- PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms(Baseline)
- PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms(6-month mid-treatment)
- PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms(Baseline)
- PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms(6-month end of treatment)
- Service Utilization Questionnaire(Baseline)
- Service Utilization Questionnaire(3-month mid-treatment)
- Service Utilization Questionnaire(6-month end of treatment)
- Parent Adolescent Relationship Questionnaire (PARQ)(Baseline)
- Parent Adolescent Relationship Questionnaire (PARQ)(6-month end of treatment)