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Family Connections for Childhood Obesity

N/A
Recruiting
Led By Silva B Fabiana, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change at 6- and 12-months post baseline
Awards & highlights

Study Summary

This trialaims to develop a culturally appropriate childhood obesity program for Latino/Hispanic families living in rural communities, delivered via telephone. It will measure cultural relevance, effectiveness, and potential for adoption, implementation & sustainability.

Who is the study for?
This trial is for Latino/Hispanic families in rural Nebraska with parents over 19 and children aged 6-12 who are overweight (BMI z-score ≥85th percentile). Families must have a phone, not plan to move or become pregnant soon, be willing to join the study randomly, and not be in another weight loss program.Check my eligibility
What is being tested?
The 'Family Connections' program aims to reduce childhood obesity through culturally adapted materials delivered via automated calls. The study will compare this approach against standard care by looking at changes in child BMI z-scores and evaluating the program's potential for wider use.See study design
What are the potential side effects?
Since this intervention involves lifestyle education rather than medication, typical medical side effects aren't expected. However, participants may experience changes in family dynamics or stress related to new health routines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change at 6- and 12-months post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and change at 6- and 12-months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child BMI z-score
Secondary outcome measures
Child acculturation
Child health literacy
Child physical activity
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Family ConnectionExperimental Treatment1 Intervention
2 in-person sessions spaced one week apart & 10 IVR calls/6 months; delivers intervention to parents only
Group II: Waitlist Standard-CareActive Control1 Intervention
6-month delayed start (waitlist) in the FC program; receive post-randomization standard health promotion materials available at the local health department; delivers intervention to parents only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Connections
2016
N/A
~50

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,780 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,777 Total Patients Enrolled
University of Nebraska LincolnOTHER
34 Previous Clinical Trials
9,790 Total Patients Enrolled

Media Library

Family Connections Clinical Trial Eligibility Overview. Trial Name: NCT04731506 — N/A
Childhood Obesity Research Study Groups: Family Connection, Waitlist Standard-Care
Childhood Obesity Clinical Trial 2023: Family Connections Highlights & Side Effects. Trial Name: NCT04731506 — N/A
Family Connections 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731506 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What measurable results are expected from this research?

"The principal outcome of this investigation, evaluated at 6- and 12-months post baseline, is the alteration in child BMI z-score. Auxiliary objectives include assessing acculturation via the Short Acculturation Scale for Hispanic Youth (SASH-Y), home environment through Comprehensive Home Environment Survey (CHES) items responses and a Child self-reported diet analysis utilizing Behavioral Risk Factor Surveillance System (BRFSS) fruits and vegetables and Beverage Intake Questionnaire (BEVQ-15)."

Answered by AI

Is the enrollment period of this research study open to individuals aged 25 and above?

"This clinical trial calls for participants between 6 to 12 years old. For young people under 18, there are 147 trials available and 28 studies catered towards senior citizens over 65."

Answered by AI

Are there still openings in this research project for participants?

"Affirmative. Clinicaltrials.gov reflects that the recruitment for this trial has been ongoing since June 1st 2021 and was recently updated on November 29th 2022. The study requires 126 enrollees from a single clinic site."

Answered by AI

Who can register for this research project?

"This trial requires 126 applicants aged between 6 and 12 who are currently battling obesity. Additionally, other criteria must be met for inclusion: minimum age of 19 years, living in the specified counties, parent to a child with BMI z-score above 85th percentile, willingness and capability to give informed consent (children participants), assent to join study (intervention adult participants)."

Answered by AI

What is the total participant count of this experimental trial?

"Affirmative. According to the data on clinicaltrials.gov, this trial is still open for recruitment, having first been posted in June 2021 and last updated November 2022. This research aims to recruit 126 people from a single site."

Answered by AI
~24 spots leftby Dec 2024