Obesity Clinical Trial
Official title:
Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research
Verified date | October 2022 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 260 |
Est. completion date | January 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Has a physical disability restricting physical activity - Has a cognitive impairment |
Country | Name | City | State |
---|---|---|---|
United States | South Texas Rural Health Services Clinic | Pearsall | Texas |
Lead Sponsor | Collaborator |
---|---|
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 |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Weight | Measured (to the nearest 0.1 kg. | Baseline, 3 months, 6 months 12 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Physical Activity (objective) | 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. | Baseline, 3 months, 6 months 12 months | |
Secondary | Physical Activity (self-report) | 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). | Baseline, 3 months, 6 months 12 months | |
Secondary | Dietary Intake | 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. | Baseline, 3 months, 6 months 12 months |
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