Evidence map›Paper›PMID 38355187›Full record

ArticleBMJ open2024

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.

Phillippe B Cunningham, Sylvie Naar, James R Roberts, Jennifer Powell, David M Ledgerwood, Jeff Randall, Brian E Lozano, Colleen A Halliday, Mohan Madisetti, Samiran Ghosh

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04974554 (Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 97% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04974554 naactive not recruitingnot on this map

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

TypeinterventionalSponsorMedical University of South CarolinaRan2021 to 2026Enrolled360ConditionsObesity, Childhood, Metabolic SyndromeArmsFIT, Home-Based Family Support
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Phillippe B CunninghamDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA cunninpb@musc.edu.ORCID 0000-0003-0814-2874
Sylvie NaarDepartment of Behavioral Sciences and Social Medicine, FSU College of Medicine, Florida State Univ, Tallahassee, Florida, USA.
James R RobertsDepartment of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.
Jennifer PowellDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
David M LedgerwoodDepartment of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, Michigan, USA.
Jeff RandallDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Brian E LozanoDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Colleen A HallidayDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Mohan MadisettiCollege of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA.
Samiran GhoshDepartment of Biostatistics and Data Science, University of Texas School of Public Health, Houston, Texas, USA.
Medical University of South Carolina · USFlorida State University · USThe University of Texas Health Science Center at Houston · USWayne State University · US

Funding

Clinical Trial of the Fit Families Multicomponent Obesity Intervetnion for African American Adolescents and Their Caregivers: Next Step from the ORBIT InitiativeR33HL155793 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI CUNNINGHAM, PHILLIPPE BELTON, GHOSH, SAMIRAN · 2022 to 2025
$3.1M
Establishing an Artificially Intelligent Framework for Improving Therapeutic Alliance with Obese African American Youth and Caregivers through Multimodal Monitoring of Empathetic Accuracy and InterperR01MD018216 · NIMHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI PHILLIPPE Belton CUNNINGHAM · 2022 to 2026
$2.5M
NHLBI NIH HHS R33 HL155793NIMHD NIH HHS R01 MD018216
6 · The paper itself

Abstract

introductionThis study will test the effectiveness of FIT Families (FIT), a multicomponent family-based behavioural intervention, against a credible attention control condition, Home-Based Family Support (HBFS). This protocol paper describes the design of a randomised clinical trial testing the efficacy of the FIT intervention. The protocol will assess the efficacy of FIT to improve health status in African American adolescents with obesity (AAAO) and their primary caregivers on primary (percent body fat) and secondary (physical activity, metabolic control, weight loss) outcomes and its cost-effectiveness.

methods180 youth/caregiver dyads are randomised into FIT or HBFS, stratified by age, gender and baseline per cent overweight. The proposed study follows a two condition (FIT, HBFS) by four assessment time points. Tests will be conducted to identify potential relationship of baseline demographic and clinical variables to our dependent variables and see whether they are balanced between groups. It is hypothesised that youth/caregiver dyads randomised to FIT will show significantly greater reductions in percent body fat over a 12-month follow-up period compared with AAAO receiving HBFS. Preliminary findings are expected by November 2023. ETHICS: This protocol received IRB approval from the Medical University of South Carolina (Pro00106021; see 'MUSC IRB 106021 Main Approval.doxc' in online supplemental materials). DISSEMINATION: Dissemination activities will include summary documents designed for distribution to the broader medical community/family audience and submission of manuscripts, based on study results, to relevant peer-reviewed scientific high-impact journals. TRIAL REGISTRATION NUMBER: NCT04974554.

Indexed as

CaregiversPediatric ObesityAdolescentBehavior TherapyBlack or African AmericanHumansOverweightRandomized Controlled Trials as TopicClinical TrialClinical trialsObesity

Identifiers

PMID38355187
PMCPMC10868253
OpenAlexW4391824797

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.