ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity

Obesity Clinical Trial

Official title:

ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808431
• Other study ID #: 080673
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 4, 2008
• Last updated: December 17, 2013
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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:

1. 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.

2. 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

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Behavioral:
• Lifestyle counseling
3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion

Locations

Country	Name	City	State
United States	Coleman Community Recreation Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth trajectories (using BMI, waist circumference), body composition		3 months	No
Secondary	Physical activity accelerometry change over time, parental self-efficacy, child feeding questionnaire (parental food habits), identification of medical home		3 months	No