Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Nutrition Poor
  • Obesity
  • Physical Activity
  • Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Care Provider, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 8 years and 125 years
Gender
Both males and females

Description

Obesity is a significant health threat in South Texas, a largely Latino region with one of the most underserved, at-risk populations in the nation. Obesity can start in early childhood and persist lifelong, setting the stage for disease.1-3 Because obesity impairs health-related quality of life and ...

Obesity is a significant health threat in South Texas, a largely Latino region with one of the most underserved, at-risk populations in the nation. Obesity can start in early childhood and persist lifelong, setting the stage for disease.1-3 Because obesity impairs health-related quality of life and billions are spent to manage obesity-related diseases,4 interventions to help obesity-affected families to adopt and maintain a healthier lifestyle and achieve a healthy weight can have great individual and public health benefits. Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity, but few studies have been translated into rural settings or for Latinos.5 Barriers to implementing lifestyle interventions in rural settings include: limited accessibility to health promotion programs, lack of health infrastructure, transportation constraints, poverty, and low levels of health literacy.6,7 To address these challenges, the proposed study will test two different methods of delivering a family-focused, culturally appropriate healthy lifestyle intervention to obese Latino adults and their families in rural South Texas. The family-focused intervention (FI), which builds on evidence from studies of urban Latino families by PI Dr. Deborah Parra-Medina and her South Texas-based research team, is a 12-week behavioral modification program grounded in the social cognitive theory of behavior change. The intervention is designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity (PA) and healthy eating, building skills in goal-setting and self-monitoring, and creating a supportive environment at home. 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). While both will be designed to address the unique social, cultural and environmental factors facing rural Latino families, the latter takes advantage of innovative technology and e-Learning to increase program availability, accessibility and program participation in rural settings. The investigators will conduct a 3-arm randomized controlled trial to compare the 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 investigators will recruit 270 obese (BMI 30-39.9kg/m2) Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These 270 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). The primary specific aims of the study are: Aim 1: Conduct community-engaged formative studies to transform the existing family-focused intervention (FI) into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent randomized controlled trial in a rural Latino community. Aim 2: Conduct a randomized controlled trial to evaluate the comparative effectiveness of two parallel delivery methods of family-focused intervention (FI-IP and FI-RT) to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with control group adults at immediate post intervention (3 months post randomization), again after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). • The investigators hypothesize that adult participants randomized to either FI-IP or FI-RT will achieve greater weight loss and improved energy balance behaviors compared with adult participants in the control group immediate post intervention (3 months post randomization), after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). The secondary aims are to examine: the impact of family-focused interventions on children's weight and energy balance behaviors; the impact of the family-focused interventions on health-related quality of life (HRQOL);8 and factors that facilitate or impede implementation and adherence to the two intervention forms. Findings from this comparative effective research will contribute to the evidence base to inform clinical and health policy decisions in regard to weight management for obese patients who may benefit from different approaches in intervention delivery.9 If successful, the remote delivery approach holds great promise in improving healthcare to underserved populations in rural and other remote locales.

Tracking Information

NCT #
NCT03186885
Collaborators
  • The University of Texas at San Antonio
  • The University of Texas Health Science Center at San Antonio
  • University of Maryland, College Park
Investigators
Principal Investigator: Deborah Parra-Medina, PhD The University of Texas at Austin