Diet ModificationNCT03469752
Latino Fathers Promoting Healthy Youth Behaviors
A study testing Parent education classes in people with Diet Modification and Physical Activity, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Physical Activity, Parenting
- What is being tested?
- Parent education classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 28 Feb 2021
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Latino adolescent 10-14 years
Who cannot join
- Not identifying as a Latino adolescent 10-14 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance related behaviors and weight status.
Read the detailed description
The Latino Parents Promoting Healthy Youth Behavior Project aims to develop and evaluate the effectiveness of an intervention to prevent obesity among Latino youth (10-14 yrs) by engaging parents and their families in culturally and linguistically appropriate education. The goal of this project is to prevent overweight and obesity in Latino adolescents by increasing the frequency of positive paternal or maternal (or other caregiver) parenting practices related to the food and physical activity environment in the home (role modeling, availability, expectations, communication) which will improve weight status of children by improving energy balance related behaviors (EBRBs) - eating fruits and vegetables and limiting soft drink, sweets, salty snacks, and fast food consumption, limiting screen time and increasing physical activity).
Objective 1) To adapt, implement and evaluate efficacy of a curriculum specifically for Latino families, using Community-Based Participatory Research (CBPR) that incorporates parenting education to increase frequency of parenting practices (role modeling, availability, expectations, communication) to improve EBRBs and weight status of youth.
Objective 2) To evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth EBRBs and weight status.
Formative research and planning will be completed in Years 1-2 including focus group interviews and consultation with community partners and a Parent Advisory Board. An existing 8-session course curriculum will be adapted. The adapted curriculum will be pilot-tested with a small group of parents and children in a single group, pre-post design, and revised as needed.
In years 2 to 4, a randomized-controlled trial (RCT) will be conducted based on full implementation of the adapted curriculum by collaborating agencies with the support of U of MN Extension. Training will be designed and implemented among community partner and U of MN Extension staff who will be implementing the program at local sites.
The RCT will be implemented at two organizations in each of years 2, 3 and 4 in a staggered fashion. In year 5, data will be analyzed, reports developed, papers written and submitted for publication, and results will be reported back to community collaborators (organizations and individuals).
Hypothesis:
- Compared to a delayed-treatment control group at immediate post-course and 3 months post-course, statistically significant changes will be observed in the home food and physical activity environment and frequency of related paternal and maternal parenting practices (making fruits, vegetables, and opportunities for physical activity more available and sugar-sweetened beverages (SSBs), sweets, salty snacks, fast food and opportunities for sedentary behaviors less available; role modeling of positive EBRBs, setting expectations and rules related to improvements in EBRBs, and increased frequency of parent-youth communication regarding youth EBRBs).
- Compared to a delayed-treatment control group at immediate post-course and 3 months post-course, youth in the treatment group will have statistically significant improvements in EBRBs including increased fruit and vegetable intake, increased physical activity, lower intake of SSBs, sweets, salty snacks and fast food, decreased screen time/sedentary time, and stable weight status.
- Conditions
- Diet Modification, Physical Activity, Parenting, Adolescent Obesity
- Being tested
- Parent education classes
- Keywords
- Hispanic Latino families
- Medical subject headings
- Motor Activity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent education classesBehavioural
8 weekly classes for fathers and youth (10-14 years) at community centers focused on improving parenting skills, youth energy balance related behaviors and weight status
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 8 weekly education sessions 2.5 hours Receives: Behavioral: Parent education classes |
| Wait-list control group | No intervention | No education sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 24-hour diet recalls
Dietary intake (fruits, vegetables, sweetened beverages, sweets and salty snacks, family meals)
Measured: Baseline to 3 months
Physical activity
Physical activity survey
Measured: Baseline to 3 months
Secondary outcomes (1)
Parenting practice survey
Frequency of role modeling, setting expectations, making opportunities for healthy choices available
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Mar 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
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 Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Model description
- Randomized-controlled trial
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469752
- Sponsor's protocol ID
- 2016-68001-24921
- Other IDs
- 2016
- Status last verified
- Aug 2021
- First submitted
- 8 Mar 2018
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baltaci A, Hurtado Choque GA, Davey C, Reyes Peralta A, Alvarez de Davila S, Zhang Y, Gold A, Larson N, Reicks M. Padres Preparados, Jovenes Saludables: intervention impact of a randomized controlled trial on Latino father and adolescent energy balance-related behaviors. BMC Public Health. 2022 Oct 18;22(1):1932. doi: 10.1186/s12889-022-14284-5.
PubMed 36258168
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latino Fathers Promoting Healthy Youth Behaviors
- ClinicalTrials.gov ID
- NCT03469752
- Acronym / sponsor ID
- 2016-68001-24921
- Conditions
- Diet Modification, Physical Activity, Parenting, Adolescent Obesity
- Keywords
- Hispanic Latino families
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 19 Mar 2018 (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.
The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance related behaviors and weight status.
Detailed description
The Latino Parents Promoting Healthy Youth Behavior Project aims to develop and evaluate the effectiveness of an intervention to prevent obesity among Latino youth (10-14 yrs) by engaging parents and their families in culturally and linguistically appropriate education. The goal of this project is to prevent overweight and obesity in Latino adolescents by increasing the frequency of positive paternal or maternal (or other caregiver) parenting practices related to the food and physical activity environment in the home (role modeling, availability, expectations, communication) which will improve weight status of children by improving energy balance related behaviors (EBRBs) - eating fruits and vegetables and limiting soft drink, sweets, salty snacks, and fast food consumption, limiting screen time and increasing physical activity).
Objective 1) To adapt, implement and evaluate efficacy of a curriculum specifically for Latino families, using Community-Based Participatory Research (CBPR) that incorporates parenting education to increase frequency of parenting practices (role modeling, availability, expectations, communication) to improve EBRBs and weight status of youth.
Objective 2) To evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth EBRBs and weight status.
Formative research and planning will be completed in Years 1-2 including focus group interviews and consultation with community partners and a Parent Advisory Board. An existing 8-session course curriculum will be adapted. The adapted curriculum will be pilot-tested with a small group of parents and children in a single group, pre-post design, and revised as needed.
In years 2 to 4, a randomized-controlled trial (RCT) will be conducted based on full implementation of the adapted curriculum by collaborating agencies with the support of U of MN Extension. Training will be designed and implemented among community partner and U of MN Extension staff who will be implementing the program at local sites.
The RCT will be implemented at two organizations in each of years 2, 3 and 4 in a staggered fashion. In year 5, data will be analyzed, reports developed, papers written and submitted for publication, and results will be reported back to community collaborators (organizations and individuals).
Hypothesis:
- Compared to a delayed-treatment control group at immediate post-course and 3 months post-course, statistically significant changes will be observed in the home food and physical activity environment and frequency of related paternal and maternal parenting practices (making fruits, vegetables, and opportunities for physical activity more available and sugar-sweetened beverages (SSBs), sweets, salty snacks, fast food and opportunities for sedentary behaviors less available; role modeling of positive EBRBs, setting expectations and rules related to improvements in EBRBs, and increased frequency of parent-youth communication regarding youth EBRBs).
- Compared to a delayed-treatment control group at immediate post-course and 3 months post-course, youth in the treatment group will have statistically significant improvements in EBRBs including increased fruit and vegetable intake, increased physical activity, lower intake of SSBs, sweets, salty snacks and fast food, decreased screen time/sedentary time, and stable weight status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Parent education classes8 weekly education sessions 2.5 hours |
| Wait-list control group | No intervention | –No education sessions |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Latino adolescent 10-14 years
Key exclusion criteria (1 listed)
- Not identifying as a Latino adolescent 10-14 years
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 |
|---|---|---|
| Parent education classes8 weekly classes for fathers and youth (10-14 years) at community centers focused on improving parenting skills, youth energy balance related behaviors and weight status | Behavioural | Intervention group |
Primary outcome
3 24-hour diet recalls
Time frame: Baseline to 3 months
Dietary intake (fruits, vegetables, sweetened beverages, sweets and salty snacks, family meals)
Physical activity
Time frame: Baseline to 3 months
Physical activity survey
1 secondary outcome
Parenting practice survey
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Derived from this study: PubMed 36258168Baltaci A, Hurtado Choque GA, Davey C, Reyes Peralta A, Alvarez de Davila S, Zhang Y, Gold A, Larson N, Reicks M. Padres Preparados, Jovenes Saludables: intervention impact of a randomized controlled trial on Latino father and adolescent energy balance-related behaviors. BMC Public Health. 2022 Oct 18;22(1):1932. doi: 10.1186/s12889-022-14284-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent education classes in people with Diet Modification and Physical Activity, run by University of Minnesota 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 1 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: finished, as of the sponsor's last update on 20 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
3 24-hour diet recalls (time frame: Baseline to 3 months). The study lists 2 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 NCT03469752, 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 20 Aug 2021.