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
|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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|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|
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.
Participants receive standard of care
- Change in Weight [ Time Frame: Baseline, 3 months, 6 months 12 months ]Measured (to the nearest 0.1 kg.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186885
|Contact: Deborah Parra-Medina, PhD||512 475 email@example.com|
|Contact: Laura A Esparza, MS||512 232 firstname.lastname@example.org|
|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|
|Principal Investigator:||Deborah Parra-Medina, PhD||The University of Texas at Austin|