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Trial record 35 of 1349 for:    rural

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

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ClinicalTrials.gov Identifier: NCT03186885
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
The University of Texas at San Antonio
The University of Texas Health Science Center at San Antonio
University of Maryland, College Park
Information provided by (Responsible Party):
Deborah Parra-Medina, University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Obesity Nutrition Poor Physical Activity Weight Loss Behavioral: Healthy Frio In-Person Family-focused Intervention Behavioral: Healthy Frio Remote Technology Family-focused Intervention Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: In-Person Family Intervention
Healthy Frio In-Person Family-focused Intervention; In-person group setting at a community center
Behavioral: Healthy Frio In-Person Family-focused Intervention
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.
Other Name: FI-IP

Experimental: Remote Technology Family Intervention
Healthy Frio Remote Technology Family-focused Intervention; Home-based delivered remotely with technology
Behavioral: Healthy Frio Remote Technology Family-focused Intervention
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.
Other Name: FI-RT

Active Comparator: Control
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
Participants receive standard of care




Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    Measured (to the nearest 0.1 kg.

  2. Change in Percent body fat [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    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.

  3. Change in Height [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    Measured to the nearest 0.5 cm will be obtained using a stadiometer. Participants will be asked to remove their shoes and heavy clothes prior to both measurements.

  4. Change in Waist circumference (minimum waist girth) [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    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.

  5. Change in BMI [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    BMI will be calculated as weight (kg)/height squared (m2) for adults and BMI percentile for age and gender for children.


Secondary Outcome Measures :
  1. Physical Activity (objective) [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    Parent and child PA level will be assessed using the Actigraph (Fort Walton Beach, FL) accelerometers worn for 7 consecutive days recording 15-second epochs. Participants must wear the accelerometer for at least 12 hours per day and on at least 4, including on weekend day, of the 7 days for reliable measurement of activity. Total minutes per day in Moderate-to-vigorous physical activity and sedentary activity will be computed with MeterPlus Software Version 4.3.

  2. Physical Activity (self-report) [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    To characterize participants' type, pattern, nature, and amount of PA, a comprehensive self-report measure will be administered, the Block Energy Expenditure Survey for adults, which measures total average energy expenditure per day and minutes per day of moderate and vigorous activities by activity type. For children, we will use the Block Kids Physical Activity Screener for school-age children and adolescents. It asks about frequency and duration of activities in the past 7 days with 9 items about leisure and school activities, chores and part-time jobs. It also asks about sedentary behavior (time spent with TV, video games, and Internet).

  3. Dietary Intake [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    We will use a validated Block Food Frequency Questionnaire (FFQ) for adults and children (2005 FFQ for Adults and 2004 FFQ for Kids ages 8-17). The correlation between the FFQ and 24-hr recalls for energy intake (0.5) and nutrients (≥ 0.4) are satisfactory. FFQ is interviewer-administered by trained bilingual research staff using a visual portion-size graphic to facilitate accurate estimation of quantities consumed. This questionnaire estimates usual and customary intake of a wide array of nutrients and food groups with additional food items typical of diets among Latinos.

  4. Health-related Quality of Life (parents only) [ Time Frame: Baseline, 3 months, 6 months 12 months ]
    The 12-Item Short Form Health Survey (SF-12) will be used to measure of general quality of life. The SF-12 replicates the physical and mental summary scales of the SF-36, explaining over 90% of the variance in each. Relative validity estimates for SF-12 summary scales average 0.67 and 0.97 for the physical component and mental components, respectively, in comparison with SF-36 subscales.



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The investigators will recruit persons (index parent) who meet the following criteria: a) self-identified Latino adult; b) obese (BMI 30-39.9kg/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.

Exclusion Criteria:

  • BMI exceeds 40 kg/m2
  • Has a physical disability restricting physical activity
  • Has a cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186885


Contacts
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Contact: Deborah Parra-Medina, PhD 512 475 9315 parramedina@austin.utexas.edu
Contact: Laura A Esparza, MS 512 232 6887 laura.esparza@austin.utexas.edu

Locations
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United States, Texas
South Texas Rural Health Services Clinic Recruiting
Pearsall, Texas, United States, 78061
Contact: Raquel Romero, MD    210-450-8010    RomeroR0@uthscsa.edu   
Sponsors and Collaborators
University of Texas at Austin
The University of Texas at San Antonio
The University of Texas Health Science Center at San Antonio
University of Maryland, College Park
Investigators
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Principal Investigator: Deborah Parra-Medina, PhD The University of Texas at Austin

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Responsible Party: Deborah Parra-Medina, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03186885     History of Changes
Other Study ID Numbers: R01NR016269 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Malnutrition
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes