DiabetesPhase 2/3NCT00808431
ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
A Phase 2/3 study testing Lifestyle counseling in people with Diabetes and Obesity, run by Vanderbilt University at 1 site in United States.
Trial summary
Preventing the onset of pediatric obesity and diabetes in Latino families The investigators will conduct a randomized controlled trial of a family-based community centered intervention. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2010
- Phase
- Phase 2/3
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Latino parents with children ages 3-5
- parent agrees to participate in all sessions
- parent can be reached via telephone contact over next 3 months
Who cannot join
- non-Latino parents
- children outside target age range
- parent not agreeing to participate in all sessions
- parent cannot be reached via telephone contact over next 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Coleman Community Recreation Center
Nashville, Tennessee, 37211
About this study
Preventing the onset of pediatric obesity and diabetes in Latino families
The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.
Read the detailed description
Obesity is a well-known risk factor for the development of diabetes. Obesity rates have rapidly increased over the past three decades for all Americans and have doubled for children. Latino children experience obesity at disproportionate rates. The most promising obesity interventions have focused on having children partner with a parent to set goals. Latino cultural norms emphasizing family provide a unique opportunity to develop family-centered interventions.
We will recruit 100 families (child-parent dyad) via a multi-pronged strategy including: provision of bilingual informational flyers; announcements on a Spanish radio program; and additional strategies developed by key community leaders in the Nolensville corridor. This recruitment approach has been successful for us in the past. Once recruited into the program, parent-child dyads will be randomly allocated to either the intervention group or control group (described below).
Intervention Group
Fifty (50) families will be randomly allocated to receive the Salud Con La Familia skills building curriculum at Coleman Community Center, which will include:
- Twelve (12) weekly 60-minute sessions in the recreation center (Refer to Table 1). The parent-child dyad will participate in 4 sessions from the En Sus Marcas curriculum, which was just tested by this study team (Barkin, PI). These sessions emphasize skills building around parenting, behavior modification, daily physical activity, and decreased sedentary activity. To this we will add 8 sessions from the Salud, Salsa, y Sabor25 curriculum, a best-practice program to improve nutrition and energy balance for Latino families, designed by the National Latino Children's Institute (NLCI) but not yet utilized in Tennessee. The combination of these two promising curricula results in a comprehensive program that includes all ADA-recommended elements of effective interventions for pediatric overweight.23 All sessions will be led by the same bilingual facilitators to ensure maximum fidelity and minimal difference between the information provided to participants. While this program has been designed in active partnership with Nashville Metro Parks and Recreation, we are also currently conducting a listening tour with key informants from the Nolensville community to provide further input into the content and implementation of the Salud Con La Familia approach. Throughout, emphasis is placed on healthy lifestyles, not on weight loss or obesity.
- At the end of each session, the study team will facilitate creating a parent-child contract to develop concrete weekly goals around nutrition and physical activity. Such contracts are integral to behavior modification.26
- The study team will assess if families have an identified pediatric medical home and use this for preventive health visits. If no medical home is identified, the team will assist with this health connection.
Control Group Fifty (50) families will be allocated to participate monthly with a literacy promotion skills-building curriculum. They will receive flyers when family events are offered at the community center. They will participate in data collection at the same time-points as the intervention families. Refer to Table 2 for our project timeline.
Outcomes will include: growth trajectories, parenting practices, activity patterns, and link to medical home.
- Being tested
- Lifestyle counseling
- Keywords
- Obesity, Diabetes, Physical Activity, Child Feeding, Growth Trajectories, Family based
- Medical subject headings
- Diabetes Mellitus, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
Also called Salud con la familia
3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Lifestyle counseling Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth trajectories (using BMI, waist circumference), body composition
Measured: 3 months
Secondary outcomes (1)
Physical activity accelerometry change over time, parental self-efficacy, child feeding questionnaire (parental food habits), identification of medical home
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJun 2010
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 DiabetesStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shari Barkin, MD, MSHS, Vanderbilt University
- Investigators
- Shari Barkin, MD, MSHS, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808431
- Sponsor's protocol ID
- 080673
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2008
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Barkin SL, Gesell SB, Po'e EK, Escarfuller J, Tempesti T. Culturally tailored, family-centered, behavioral obesity intervention for Latino-American preschool-aged children. Pediatrics. 2012 Sep;130(3):445-56. doi: 10.1542/peds.2011-3762. Epub 2012 Aug 6.
PubMed 22869834
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
- ClinicalTrials.gov ID
- NCT00808431
- Acronym / sponsor ID
- 080673
- Keywords
- Obesity, Diabetes, Physical Activity, Child Feeding, Growth Trajectories, Family based
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Dec 2008 (estimated)
- 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.
Preventing the onset of pediatric obesity and diabetes in Latino families
The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.
Detailed description
Obesity is a well-known risk factor for the development of diabetes. Obesity rates have rapidly increased over the past three decades for all Americans and have doubled for children. Latino children experience obesity at disproportionate rates. The most promising obesity interventions have focused on having children partner with a parent to set goals. Latino cultural norms emphasizing family provide a unique opportunity to develop family-centered interventions.
We will recruit 100 families (child-parent dyad) via a multi-pronged strategy including: provision of bilingual informational flyers; announcements on a Spanish radio program; and additional strategies developed by key community leaders in the Nolensville corridor. This recruitment approach has been successful for us in the past. Once recruited into the program, parent-child dyads will be randomly allocated to either the intervention group or control group (described below).
Intervention Group
Fifty (50) families will be randomly allocated to receive the Salud Con La Familia skills building curriculum at Coleman Community Center, which will include:
- Twelve (12) weekly 60-minute sessions in the recreation center (Refer to Table 1). The parent-child dyad will participate in 4 sessions from the En Sus Marcas curriculum, which was just tested by this study team (Barkin, PI). These sessions emphasize skills building around parenting, behavior modification, daily physical activity, and decreased sedentary activity. To this we will add 8 sessions from the Salud, Salsa, y Sabor25 curriculum, a best-practice program to improve nutrition and energy balance for Latino families, designed by the National Latino Children's Institute (NLCI) but not yet utilized in Tennessee. The combination of these two promising curricula results in a comprehensive program that includes all ADA-recommended elements of effective interventions for pediatric overweight.23 All sessions will be led by the same bilingual facilitators to ensure maximum fidelity and minimal difference between the information provided to participants. While this program has been designed in active partnership with Nashville Metro Parks and Recreation, we are also currently conducting a listening tour with key informants from the Nolensville community to provide further input into the content and implementation of the Salud Con La Familia approach. Throughout, emphasis is placed on healthy lifestyles, not on weight loss or obesity.
- At the end of each session, the study team will facilitate creating a parent-child contract to develop concrete weekly goals around nutrition and physical activity. Such contracts are integral to behavior modification.26
- The study team will assess if families have an identified pediatric medical home and use this for preventive health visits. If no medical home is identified, the team will assist with this health connection.
Control Group Fifty (50) families will be allocated to participate monthly with a literacy promotion skills-building curriculum. They will receive flyers when family events are offered at the community center. They will participate in data collection at the same time-points as the intervention families. Refer to Table 2 for our project timeline.
Outcomes will include: growth trajectories, parenting practices, activity patterns, and link to medical home.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingLifestyle counseling |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Latino parents with children ages 3-5
- parent agrees to participate in all sessions
- parent can be reached via telephone contact over next 3 months
Key exclusion criteria (4 listed)
- non-Latino parents
- children outside target age range
- parent not agreeing to participate in all sessions
- parent cannot be reached via telephone contact over next 3 months
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 |
|---|---|---|
| Lifestyle counselingAlso: Salud con la familia3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion | Behavioural | Lifestyle counseling |
Primary outcome
Growth trajectories (using BMI, waist circumference), body composition
Time frame: 3 months
1 secondary outcome
Physical activity accelerometry change over time, parental self-efficacy, child feeding questionnaire (parental food habits), identification of medical home
Time frame: 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 19 Dec 2013.
- Derived from this study: PubMed 22869834Barkin SL, Gesell SB, Po'e EK, Escarfuller J, Tempesti T. Culturally tailored, family-centered, behavioral obesity intervention for Latino-American preschool-aged children. Pediatrics. 2012 Sep;130(3):445-56. doi: 10.1542/peds.2011-3762. Epub 2012 Aug 6.
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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.
Shari Barkin, MD, MSHS principal investigator
Vanderbilt University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lifestyle counseling in people with Diabetes and Obesity, run by Vanderbilt University 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 3 inclusion and 4 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 19 Dec 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Growth trajectories (using BMI, waist circumference), body composition (time frame: 3 months). 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 NCT00808431, 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 19 Dec 2013.