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NCT Number: NCT04974554

FIT Families Multicomponent Obesity Intervention for African American Adolescents

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.

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Key information

Conditions

Obesity, Childhood Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Global and Community Health

Charleston, South Carolina, 29407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FIT

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Height

    Time frame: Baseline

    Height in meters will be obtained using a portable stadiometer.

  6. Height

    Time frame: 3-month mid-treatment

    Height in meters will be obtained using a portable stadiometer.

  7. Height

    Time frame: 6-month end of treatment

    Height in meters will be obtained using a portable stadiometer.

  8. Height

    Time frame: 12-month follow-up

    Height in meters will be obtained using a portable stadiometer.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. Percent overweight

    Time frame: Baseline

    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.

  2. Percent overweight

    Time frame: 3 month mid-treatment

    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. Percent overweight

    Time frame: 6 month end of treatment

    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.

  4. Percent overweight

    Time frame: 12 month follow-up

    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.

  5. Physical activity

    Time frame: baseline

    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. Physical activity

    Time frame: 3-month mid-treatment

    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

  7. Physical activity

    Time frame: 6-month end of treatment

    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

  8. Physical activity

    Time frame: 12-month follow-up

    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

  9. Self-monitoring of physical activity (PA)

    Time frame: Daily for six months during treatment

    Self-Monitoring of PA is assessed using daily diary logbooks completed on line

  10. Self-monitoring of Dietary Intake

    Time frame: Daily for six months during treatment

    Self-Monitoring of Dietary Intake is assessed using daily diary logbooks completed on line

  11. Symptoms of Metabolic Syndrome

    Time frame: Baseline

    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. Symptoms of Metabolic Syndrome

    Time frame: Baseline

    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  13. Symptoms of Metabolic Syndrome

    Time frame: 3-month mid-treatment

    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.

  14. Symptoms of Metabolic Syndrome

    Time frame: 3-month mid-treatment

    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  15. Symptoms of Metabolic Syndrome

    Time frame: 6-month end of treatment

    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.

  16. Symptoms of Metabolic Syndrome

    Time frame: 6-month end of treatment

    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  17. Symptoms of Metabolic Syndrome

    Time frame: 12-month follow-up

    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.

  18. Symptoms of Metabolic Syndrome

    Time frame: 12-month follow-up

    Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.

  19. Hemoglobin A1c (HbA1c)

    Time frame: Baseline

    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.

  20. Hemoglobin A1c (HbA1c)

    Time frame: 3-month mid-treatment

    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.

  21. Hemoglobin A1c (HbA1c)

    Time frame: 6-month end of treatment

    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.

  22. Hemoglobin A1c (HbA1c)

    Time frame: 12-month follow-up

    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.

  23. Flanker task

    Time frame: Baseline

    Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.

  24. Flanker task

    Time frame: 6-month end of treatment

    Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.

  25. Flanker task

    Time frame: 12-month follow-up

    Objective sub tests measuring attention and executive functioning. Scores range from 0 to 30, and the total score is used as an outcome.

  26. List Sorting test

    Time frame: Baseline

    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).

  27. List Sorting test

    Time frame: 6-month end of treatment

    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).

  28. List Sorting test

    Time frame: 12-month follow-up

    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).

  29. Delayed Reward Discounting Task

    Time frame: Baseline

    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.

  30. NEURO-QOL

    Time frame: 6-month end of treatment

    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.

  31. Delayed Reward Discounting Task

    Time frame: 6-month end of treatment

    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.

  32. Delayed Reward Discounting Task

    Time frame: 12-month follow-up

    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.

  33. NEURO-QOL

    Time frame: Baseline

    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.

  34. NEURO-QOL

    Time frame: 12-month follow-up

    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.

  35. Brief Symptom Inventory

    Time frame: Baseline

    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.

  36. Brief Symptom Inventory

    Time frame: 6-month mid-treatment

    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.

  37. Brief Symptom Inventory

    Time frame: 12-month end of treatment

    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.

  38. PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms

    Time frame: Baseline

    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.

  39. PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms

    Time frame: 6-month mid-treatment

    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.

  40. PROMIS - Pediatric Short Form v1.0 - Depressive Symptoms

    Time frame: 12-month follow-up

    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.

  41. PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms

    Time frame: Baseline

    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.

  42. PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms

    Time frame: 6-month end of treatment

    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.

  43. PROMIS - Pediatric Short Form v1.0 - Anxiety Symptoms

    Time frame: 12-month follow-up

    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.

  44. Working Alliance Inventory

    Time frame: Monthly during the six months of treatment.

    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.

  45. Service Utilization Questionnaire

    Time frame: Baseline

    Other services the youth may receive besides treatment conditions

  46. Service Utilization Questionnaire

    Time frame: 3-month mid-treatment

    Other services the youth may receive besides treatment conditions

  47. Service Utilization Questionnaire

    Time frame: 6-month end of treatment

    Other services the youth may receive besides treatment conditions

  48. Service Utilization Questionnaire

    Time frame: 12-month follow-up

    Other services the youth may receive besides treatment conditions

  49. Parent Adolescent Relationship Questionnaire (PARQ)

    Time frame: Baseline

    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.

  50. Parent Adolescent Relationship Questionnaire (PARQ)

    Time frame: 6-month end of treatment

    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.

  51. Parent Adolescent Relationship Questionnaire (PARQ)

    Time frame: 12-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Florida State University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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