FIT Families Multicomponent Obesity Intervention for African American Adolescents

NCT04974554 | Active Not Recruiting DMC

• 3 other identifiers: 00106021161HL155793-014R33HL155793-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is one of the most prevalent medical problems facing children and adolescents today, particularly among African American adolescents where the rate is alarmingly high. This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to meet the unique needs of African American adolescents with obesity and their caregivers, against a credible attention control condition. This study has considerable public health relevance because it is delivered by Community Health Workers, maximizing the potential for the intervention to be sustained, and may reduce obesity-related health problems for a vulnerable population of adolescents.

Conditions

Obesity, Childhood; Metabolic Syndrome

Keywords

obesity, African American adolescents

Outcome Measures

Primary Outcomes (12)

• 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

• 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 Outcomes (51)

• Percent overweight

  Baseline

• Percent overweight

  3 month mid-treatment

• Percent overweight

  6 month end of treatment

• Percent overweight

  12 month follow-up

• Physical activity

  baseline

Study Arms (2)

FIT Families

EXPERIMENTAL

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

Home-Based Family Support

ACTIVE COMPARATOR

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

Interventions

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.

FIT Families

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.

Home-Based Family Support

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Florida State University: collaborator
• Wayne State University: collaborator

Study Sites (1)

Division of Global and Community Health

Charleston, South Carolina, 29407, United States

Location

Related Publications (2)

• 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.

  PMID: 38355187 BACKGROUND

• 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.

  PMID: 37676364 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohan Madisetti, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Phillippe B Cunningham, PhD

  UTHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study Biostatistician will conduct the randomization of 180 subjects, 90 subjects per condition (FIT vs. HBFS) using a 1:1 allocation ratio. Research Assistants collecting data will be kept blind to participants' randomization status to the extent possible in a behavioral clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 23, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)