Study Summary
This trial is testing two different ways of delivering a lifestyle intervention to obese Latino adults and their children in a rural community, to see if either is more effective than a control group in terms of weight loss and energy balance behaviors.
Eligible Conditions
- Obesity
- Weight Loss
- Malnutrition
- Physical Activity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 4 Secondary · Reporting Duration: Baseline, 3 months, 6 months 12 months
Month 12
Change in BMI
Change in Height
Change in Percent body fat
Change in Waist circumference (minimum waist girth)
Change in Weight
Dietary Intake
Health-related Quality of Life (parents only)
Physical Activity (objective)
Physical Activity (self-report)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Control
1 of 3
Remote Technology Family Intervention
1 of 3
In-Person Family Intervention
1 of 3
Active Control
Experimental Treatment
260 Total Participants · 3 Treatment Groups
Primary Treatment: Healthy Frio In-Person Family-focused Intervention · No Placebo Group · N/A
Remote Technology Family Intervention
Behavioral
Experimental Group · 1 Intervention: Healthy Frio Remote Technology Family-focused Intervention · Intervention Types: BehavioralIn-Person Family Intervention
Behavioral
Experimental Group · 1 Intervention: Healthy Frio In-Person Family-focused Intervention · Intervention Types: BehavioralControl
Behavioral
ActiveComparator Group · 1 Intervention: Control · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months 12 months
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
289 Previous Clinical Trials
67,107 Total Patients Enrolled
8 Trials studying Obesity
5,590 Patients Enrolled for Obesity
The University of Texas at San AntonioOTHER
20 Previous Clinical Trials
5,995 Total Patients Enrolled
4 Trials studying Obesity
1,276 Patients Enrolled for Obesity
The University of Texas Health Science Center at San AntonioOTHER
399 Previous Clinical Trials
73,465 Total Patients Enrolled
6 Trials studying Obesity
850 Patients Enrolled for Obesity
University of MarylandOTHER
148 Previous Clinical Trials
298,326 Total Patients Enrolled
6 Trials studying Obesity
4,226 Patients Enrolled for Obesity
University of Maryland, College ParkOTHER
143 Previous Clinical Trials
41,917 Total Patients Enrolled
3 Trials studying Obesity
6,978 Patients Enrolled for Obesity
Deborah Parra-Medina, PhDPrincipal Investigator - The University of Texas at Austin
University of Texas at Austin
3 Previous Clinical Trials
908 Total Patients Enrolled
2 Trials studying Obesity
642 Patients Enrolled for Obesity
Eligibility Criteria
Age Any Age · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| South Texas Rural Health Services Clinic | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Yin Z, Errisuriz VL, Evans M, Inupakutika D, Kaghyan S, Li S, Esparza L, Akopian D, Parra-Medina D. A Digital Health Intervention for Weight Management for Latino Families Living in Rural Communities: Perspectives and Lessons Learned During Development. JMIR Form Res. 2020 Aug 20;4(8):e20679. doi: 10.2196/20679.
- Deborah Parra-Medina 2017. "Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03186885.
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Conditions
Cancer Related
Treatments