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

NCT03186885 | Unknown

• 1 other identifier: R01NR016269
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Nutrition Poor; Physical Activity; Weight Loss

Outcome Measures

Primary Outcomes (4)

• Change in Weight

  Measured (to the nearest 0.1 kg.

  Baseline, 3 months, 6 months 12 months

• Change in Percent body fat

  Measured by bioelectrical impedance analysis (BIA) using the foot-to-foot pressure contact electrode BIA technique using a portable Tanita Body Composition Analyzer following standard protocol.

  Baseline, 3 months, 6 months 12 months

• Change in Waist circumference (minimum waist girth)

  Will be measured to the nearest 0.1 cm using a retractable, tension-controlled metal tape measure at the midway between the right iliac crests and the lower ribs when the subject is standing erect with feet together.

  Baseline, 3 months, 6 months 12 months

• Change in BMI

  BMI will be calculated as weight (kg)/height squared (m2) for adults and BMI percentile for age and gender for children.

  Baseline, 3 months, 6 months 12 months

Secondary Outcomes (3)

• Physical Activity (objective)

  Baseline, 3 months, 6 months 12 months

• Physical Activity (self-report)

  Baseline, 3 months, 6 months 12 months

• Dietary Intake

  Baseline, 3 months, 6 months 12 months

Study Arms (3)

In-Person Family Intervention

EXPERIMENTAL

Healthy Frio In-Person Family-focused Intervention; In-person group setting at a community center

Behavioral: Healthy Frio In-Person Family-focused Intervention

Remote Technology Family Intervention

EXPERIMENTAL

Healthy Frio Remote Technology Family-focused Intervention; Home-based delivered remotely with technology

Behavioral: Healthy Frio Remote Technology Family-focused Intervention

Control

ACTIVE COMPARATOR

Control; Participants will receive standard health education materials, a community resource guide, and encouragement to follow up with their primary care provider for office-based counseling.

Behavioral: Control

Interventions

Healthy Frio In-Person Family-focused Intervention BEHAVIORAL

Participants learn about energy balance behaviors, skills to support health behavior change, managing personal wellness, and parenting strategies. Sessions use interactive learning strategies to elicit knowledge and experience of participating families to encourage families to learn from each other. YMCA staff members lead a 50-minute group exercise session after each health education session to help participants meet their commitment of engaging in PA at least 3 times/week.

Also known as: FI-IP

In-Person Family Intervention

Healthy Frio Remote Technology Family-focused Intervention BEHAVIORAL

Tablet computers will be used as the platform to deliver the health education content for the FI-RT. Each session will present the class content and guide the participants to complete class activities. Videos of health education and class activities (e.g., cooking demonstrations, exercise demonstrations) will be embedded in the lesson. Interactive assessment questions with feedback will be presented throughout the session to check for understanding of the content. Viewing time and responses to the assessment questions will be recorded to evaluate progress and comprehension. Participants will view the health education sessions at home as a family and discuss the content as prompted by lesson instructions.

Also known as: FI-RT

Remote Technology Family Intervention

Control BEHAVIORAL

Participants receive standard of care

Control

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will recruit persons (index parent) who meet the following criteria: a) self-identified Latino adult; b) overweight or obese (BMI \>= 25 kg/m2); c)not currently enrolled in a formal weight loss program or taking weight loss medications; d) no restriction for PA (i.e., no significant physical disability); e) having a smart phone;f) speaks and reads English; g) one child aged 8-17 (with no regard to obesity status) residing with the parent full-time and willing to participate; and h) receiving care at a study clinic.

You may not qualify if:

• Has a physical disability restricting physical activity
• Has a cognitive impairment

Sponsors & Collaborators

• University of Texas at Austin: lead
• The University of Texas at San Antonio: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• University of Maryland: collaborator

Study Sites (1)

South Texas Rural Health Services Clinic

Pearsall, Texas, 78061, United States

Location

Related Publications (1)

• 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.

  PMID: 32726748 BACKGROUND

Related Links

• A Digiral Health Intervention for Weight Management For Latino Families Living in Rural Communities

MeSH Terms

Conditions

Obesity; Malnutrition; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Study Officials

• Deborah Parra-Medina, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)