An interventional study of FIT and Home-Based Family Support in Obesity, Childhood and Metabolic Syndrome, sponsored by Medical University of South Carolina. Active, not recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's planned enrollment of 360 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
Exclusion criteria that apply to both adolescents and caregivers are:
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
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
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 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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12-month follow-up
Height
Height in meters will be obtained using a portable stadiometer.
Time frame: Baseline
Height
Height in meters will be obtained using a portable stadiometer.
Time frame: 3-month mid-treatment
Height
Height in meters will be obtained using a portable stadiometer.
Time frame: 6-month end of treatment
Height
Height in meters will be obtained using a portable stadiometer.
Time frame: 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.
Time frame: Baseline
Weight
Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.
Time frame: 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.
Time frame: 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.
Time frame: 12-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12-month follow-up
Self-monitoring of physical activity (PA)
Self-Monitoring of PA is assessed using daily diary logbooks completed on line
Time frame: 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
Time frame: 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.
Time frame: Baseline
Symptoms of Metabolic Syndrome
Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Monthly during the six months of treatment.
Service Utilization Questionnaire
Other services the youth may receive besides treatment conditions
Time frame: Baseline
Service Utilization Questionnaire
Other services the youth may receive besides treatment conditions
Time frame: 3-month mid-treatment
Service Utilization Questionnaire
Other services the youth may receive besides treatment conditions
Time frame: 6-month end of treatment
Service Utilization Questionnaire
Other services the youth may receive besides treatment conditions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-month follow-up
Plan to share: Yes — At the expiration of the study locked data files and variable and scale dictionaries will be made available to the NIH for archiving and sharing with other researchers, in accordance with NIH policies. The Contact PI (Cunningham) will ensure that all datasets provided will be prepared in accordance with NHLBI requirements for data repository and associated documentation for submission to the Biological Specimen and Data Repository Information Coordinating Center; NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies; and NHLBI Guidelines for Data Set Preparation. Results from the proposed study will be presented in required reports to NIH. Additionally, results will be presented to clinical researchers, clinical treatment organizations, and state and national legislative bodies as requested. Within one year of completion of the study and publication of the main study findings we will make available the datasets publicly.
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Medical University of South Carolina