FIT Families Multicomponent Obesity Intervention for African American Adolescents

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04974554
• Other study ID #: 00106021
• Secondary ID: 161HL155793-014R
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: Phillippe B Cunningham, Ph.D.
• Phone: 843-876-1800
• Email: cunninpb[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• FIT
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
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.

Locations

Country	Name	City	State
United States	Division of Global and Community Health	Charleston	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of South Carolina	Florida State University, National Heart, Lung, and Blood Institute (NHLBI), Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Height	Height in meters will be obtained using a portable stadiometer.	Baseline
Primary	Height	Height in meters will be obtained using a portable stadiometer.	3-month mid-treatment
Primary	Height	Height in meters will be obtained using a portable stadiometer.	6-month end of treatment
Primary	Height	Height in meters will be obtained using a portable stadiometer.	12-month follow-up
Primary	Weight	Weight in kilograms will be assessed using a portable digital scale with the capacity to reliably obtain weights up to 600 pounds.	Baseline
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Symptoms of Metabolic Syndrome	Blood pressure is measured with a sphygmomanometer 3 times, with the second and third measurement averaged for analysis.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Service Utilization Questionnaire	Other services the youth may receive besides treatment conditions	Baseline
Secondary	Service Utilization Questionnaire	Other services the youth may receive besides treatment conditions	3-month mid-treatment
Secondary	Service Utilization Questionnaire	Other services the youth may receive besides treatment conditions	6-month end of treatment
Secondary	Service Utilization Questionnaire	Other services the youth may receive besides treatment conditions	12-month follow-up
Secondary	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
Secondary	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
Secondary	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