ObesityNCT03186885
Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research
A study testing Healthy Frio In-Person Family-focused Intervention and Healthy Frio Remote Technology Family-focused Intervention in people with Obesity and Nutrition Poor, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Obesity, Nutrition Poor, Physical Activity
- What is being tested?
- Healthy Frio In-Person Family-focused Intervention and Healthy Frio Remote Technology Family-focused Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has a physical disability restricting physical activity
- Has a cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Rural Health Services Clinic
Pearsall, Texas, 78061
About this study
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.
Read the detailed 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 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.
- Conditions
- Obesity, Nutrition Poor, Physical Activity, Weight Loss
- Being tested
- Healthy Frio In-Person Family-focused Intervention, Healthy Frio Remote Technology Family-focused Intervention, Control
- Medical subject headings
- Obesity, Malnutrition, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Frio In-Person Family-focused InterventionBehavioural
Also called FI-IP
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.
Healthy Frio Remote Technology Family-focused InterventionBehavioural
Also called FI-RT
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.
ControlBehavioural
Participants receive standard of care
| Study group | Role | What they receive |
|---|---|---|
| In-Person Family Intervention | Experimental | Healthy Frio In-Person Family-focused Intervention; In-person group setting at a community center Receives: 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 Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured (to the nearest 0.1 kg.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months 12 months
Secondary outcomes (3)
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.
Measured: Baseline, 3 months, 6 months 12 months
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).
Measured: Baseline, 3 months, 6 months 12 months
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.
Measured: Baseline, 3 months, 6 months 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas at San Antonio, The University of Texas Health Science Center at San Antonio, University of Maryland
- Responsible party
- Principal investigator, Deborah Parra-Medina, University of Texas at Austin
- Investigators
- Deborah Parra-Medina, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186885
- Sponsor's protocol ID
- R01NR016269
- Status last verified
- Oct 2022
- First submitted
- 9 Jun 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32726748
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research
- ClinicalTrials.gov ID
- NCT03186885
- Acronym / sponsor ID
- R01NR016269
- Conditions
- Obesity, Nutrition Poor, Physical Activity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- The University of Texas at San Antonio, The University of Texas Health Science Center at San Antonio, University of Maryland
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-Person Family Intervention | Experimental | Behavioral: Healthy Frio In-Person Family-focused InterventionHealthy Frio In-Person Family-focused Intervention; In-person group setting at a community center |
| Remote Technology Family Intervention | Experimental | Behavioral: Healthy Frio Remote Technology Family-focused InterventionHealthy Frio Remote Technology Family-focused Intervention; Home-based delivered remotely with technology |
| Control | Active comparator | Behavioral: ControlControl; 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Has a physical disability restricting physical activity
- Has a cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Frio In-Person Family-focused InterventionAlso: FI-IPParticipants 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. | Behavioural | In-Person Family Intervention |
| Healthy Frio Remote Technology Family-focused InterventionAlso: FI-RTTablet 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. | Behavioural | Remote Technology Family Intervention |
| ControlParticipants receive standard of care | Behavioural | Control |
Primary outcome
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 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.
3 secondary outcomes
Physical Activity (objective)
Time frame: Baseline, 3 months, 6 months 12 months
Physical Activity (self-report)
Time frame: Baseline, 3 months, 6 months 12 months
Dietary Intake
Time frame: Baseline, 3 months, 6 months 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 32726748Yin 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.
- A Digiral Health Intervention for Weight Management For Latino Families Living in Rural CommunitiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Parra-Medina, PhD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Frio In-Person Family-focused Intervention and Healthy Frio Remote Technology Family-focused Intervention in people with Obesity and Nutrition Poor, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Baseline, 3 months, 6 months 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.