FIT Families Multicomponent Obesity Intervention for African American Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step From the ORBIT Initiative

Conditions
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Obesity, Childhood, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: FIT
* Behavioral: Home-Based Family Support


Participation Criteria
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Eligibility Criteria
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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: pregnancy, thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal serious cognitive impairment (e.g., inability to complete questionnaires)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIT Families<br>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. | Behavioral: FIT<br>* 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.<br>|
| Active Comparator: Home-Based Family Support<br>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. | Behavioral: Home-Based Family Support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent overweight | Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer. | Baseline | 
| Percent overweight | Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer. | 3 month mid-treatment | 
| Percent overweight | Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer. | 6 month end of treatment | 
| Percent overweight | Percent Overweight will be calculated as the percentage BMI above the Centers for Disease Control's (CDC's) median BMI for age and gender. Body Mass Index (BMI) in kg/m2 will subsequently be calculated and converted to BMI percentile using age and gender norms from the CDC. Body Mass Index (BMI) in kg/m2 will be calculated from in home weight and height measurements. Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. Height in meters will be obtained using a portable stadiometer. | 12 month follow-up | 
| Height | Height in meters will be obtained using a portable stadiometer. | Baseline | 
| Height | Height in meters will be obtained using a portable stadiometer. | 3-month mid-treatment | 
| Height | Height in meters will be obtained using a portable stadiometer. | 6-month end of treatment | 
| Height | Height in meters will be obtained using a portable stadiometer. | 12-month follow-up | 
| Weight | Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. | Baseline | 
| Weight | Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. | 3-month mid-treatment | 
| Weight | Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. | 6-month mid-treatment | 
| Weight | Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds. | 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of body fat | 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 | Baseline | 
| Percent of body fat | 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 | 3-month mid-treatment | 
| Percent of body fat | 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 | 6-month end of treatment | 
| Percent of body fat | 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 | 12-month follow-up | 
| Physical activity | Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns | baseline | 
| Physical activity | Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns | 3-month mid-treatment | 
| Physical activity | Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns | 6-month end of treatment | 
| Physical activity | Physical activity is assessed using the compact FitBit Flex2 accelerometer, which utilizes a tri-axial accelerometer and digital filtering proprietary machine-learning algorithms to analyze and estimate human movement patterns | 12-month follow-up | 
| Self-monitoring of physical activity (PA) | Self-Monitoring of PA is assessed using daily diary logbooks completed on line | Daily for six months during treatment | 
| Self-monitoring of Dietary Intake | Self-Monitoring of Dietary Intake is assessed using daily diary logbooks completed on line | Daily for six months during treatment | 
| Symptoms of Metabolic Syndrome | Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood. | Baseline | 
| Symptoms of Metabolic Syndrome | Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis. | Baseline | 
| Symptoms of Metabolic Syndrome | Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood. | 3-month mid-treatment | 
| Symptoms of Metabolic Syndrome | Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis. | 3-month mid-treatment | 
| Symptoms of Metabolic Syndrome | Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood. | 6-month end of treatment | 
| Symptoms of Metabolic Syndrome | Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis. | 6-month end of treatment | 
| Symptoms of Metabolic Syndrome | Blood samples are obtained after a 10-12 hour fast for measurement of plasma glucose, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels. Blood glucose and lipid levels are measured using the Alere Cholestech LDX, a psychometrically sound point of care analyzer that requires only one drop of whole blood. | 12-month follow-up | 
| Symptoms of Metabolic Syndrome | Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis. | 12-month follow-up | 
| Hemoglobin A1c (HbA1c) | HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture. | Baseline | 
| Hemoglobin A1c (HbA1c) | HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture. | 3-month mid-treatment | 
| Hemoglobin A1c (HbA1c) | HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture. | 6-month end of treatment | 
| Hemoglobin A1c (HbA1c) | HbA1c is obtained using the Accubase A1c test kit,102 and FDA approved test that uses a capillary tube blood collection method instead of venipuncture. | 12-month follow-up | 
| Flanker task | Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome. | Baseline | 
| Flanker task | Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome. | 6-month end of treatment | 
| Flanker task | Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome. | 12-month follow-up | 
| List Sorting test | Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10). | Baseline | 
| List Sorting test | Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10). | 6-month end of treatment | 
| List Sorting test | Measures working memory. List Sorting scores are based upon a sum of the total correct across both lists which comprise the List Sorting Total Score. The raw sum score is then transformed to a standardized t-metric (mean=50, 50 and SD=10). | 12-month follow-up | 
| Delayed Reward Discounting Task | Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity. | Baseline | 
| Delayed Reward Discounting Task | Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity. | 6-month end of treatment | 
| Delayed Reward Discounting Task | Assess degree of preference for immediate over delayed rewards. The protocol is scored by by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity. | 12-month follow-up | 
| NEURO-QOL | self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured. | Baseline | 
| NEURO-QOL | self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured. | 6-month end of treatment | 
| NEURO-QOL | self-report about concerns about cognitive functioning over the previous week; quality of life. Neuro-QOL uses a T score which has a mean of 50 and the standard deviation of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured. | 12-month follow-up | 
| Brief Symptom Inventory | Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress. | Baseline | 
| Brief Symptom Inventory | Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress. | 6-month mid-treatment | 
| Brief Symptom Inventory | Caregiver psychological symptoms. Each item of individual psychological stress is answered on a 5-point scale, ranging from 0 = not at all to 4 = extremely, with higher scores indicating more distress. | 12-month end of treatment | 
| PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms | Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression. | Baseline | 
| PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms | Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression. | 6-month mid-treatment | 
| PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms | Adolescent depressive symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more depression. | 12-month follow-up | 
| PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms | Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety. | Baseline | 
| PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms | Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety. | 6-month end of treatment | 
| PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms | Adolescent anxiety symptoms. The final score is represented by the T -score, that has a mean of 50 and a standard deviation of 10. With higher scores indicating more anxiety. | 12-month follow-up | 
| Working Alliance Inventory | Quality of the therapeutic relationship. The WAI is scored on a 7-point Likert-type scale ranging from 1 (never) to 7 (always. Subscales can range from 12-83 and can be summed to obtain a total score-which range from 36-252. Higher scores reflect more positive ratings of the working alliance. | Monthly during the six months of treatment. | 
| Service Utilization Questionnaire | Other services the youth may receive besides treatment conditions | Baseline | 
| Service Utilization Questionnaire | Other services the youth may receive besides treatment conditions | 3-month mid-treatment | 
| Service Utilization Questionnaire | Other services the youth may receive besides treatment conditions | 6-month end of treatment | 
| Service Utilization Questionnaire | Other services the youth may receive besides treatment conditions | 12-month follow-up | 
| Parent Adolescent Relationship Questionnaire (PARQ) | The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship. | Baseline | 
| Parent Adolescent Relationship Questionnaire (PARQ) | The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship. | 6-month end of treatment | 
| Parent Adolescent Relationship Questionnaire (PARQ) | The PARQ is a psychometrically sound family functioning measure that is based on behavioral family systems therapy, and has been used in effectiveness research. Respondents are asked indicate if a statement that describes thoughts, feelings, and beliefs about their family is true or false. The PARQ items are summed to obtain a total score, with higher scores reflect more positive aspects of the parent-adolescent relationship. | 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, African American adolescents