NCT03186885

Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research

Status unknown NA Last updated 3 November 2022

What this trial tests

NA trial testing Healthy Frio In-Person Family-focused Intervention in Obesity in 260 participants. Status unknown.

Timeline

1 November 2017

Primary endpoint
31 December 2022

31 January 2023

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	260
Start date	1 November 2017
Primary completion	31 December 2022
Estimated completion	31 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Healthy Frio In-Person Family-focused Intervention
• Healthy Frio Remote Technology Family-focused Intervention
• Control

Conditions studied

• Obesity — all drugs for Obesity →
• Nutrition Poor — all drugs for Nutrition Poor →
• Physical Activity — all drugs for Physical Activity →
• Weight Loss — all drugs for Weight Loss →

Sponsor

University of Texas at Austin

Who can join

8 and older, any sex, with Obesity or Nutrition Poor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity. Few studies have been translated into rural settings or among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for urban Latino families. The FI is a 12-week behavioral modification program grounded in social cognitive theory, designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity and healthy eating, building skills in goal-setting and self-monitoring, and creating a supportive home environment. Researchers will engage community partners in formative research to adapt the current FI for rural Latino families. Two parallel delivery methods of the FI will be developed and tested: 1) in-person group setting at a community center (FI-IP) and 2) home-based delivered remotely with technology (FI-RT). Both will be designed to address the unique social, cultural and environmental factors facing rural Latino families. The FI-RT will take advantage of innovative modern technology and e-Learning to increase program availability, accessibility and participation in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to compare effectiveness of the two delivery approaches on weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These parent-child pairs will be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or 3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with adult participants in control group at immediate post intervention (3 months), after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's weight and energy balance behaviors.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Digital Health Intervention for Weight Management for Latino Families Living in Rural Communities: Perspectives and Lessons Learned During Development.
   Yin Z, Errisuriz VL, Evans M, Inupakutika D, et al · · 2020 · cited 5× · PMID 32726748 · DOI 10.2196/20679