Smart and Secure Children Program for Preschool Obesity
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 2 - 5 |
| Updated: | 6/29/2016 |
| Start Date: | December 2015 |
| End Date: | December 2020 |
| Contact: | Ashley Butler, Ph.D |
| Email: | ambutler@bcm.edu |
| Phone: | 832-822-4899 |
Feasibility Study of the Modified-Smart and Secure Children Program in Primary Care
Many behavioral interventions designed to improve dietary patterns for ethnic and
racial/minority preschoolers have produced modest outcomes. A limitation of these
interventions include a failure to address key factors associated with dietary patterns for
these children, such as parental stress levels. Therefore, the identification of
intervention models that target these factors and are effective, acceptable, and feasible
among parents of young minority children is important.
Subjects will be asked to take part in this study because they are the parents of a child
that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being
done and their child's body mass index has been at or above the 85th percentile.
The purpose of this pilot study is to assess the ease and acceptance of providing an
intervention for parents of children ages 2-5 years in the pediatric primary care clinic.
The purpose is to also assess how well the intervention works in improving the child's
dietary patterns.
racial/minority preschoolers have produced modest outcomes. A limitation of these
interventions include a failure to address key factors associated with dietary patterns for
these children, such as parental stress levels. Therefore, the identification of
intervention models that target these factors and are effective, acceptable, and feasible
among parents of young minority children is important.
Subjects will be asked to take part in this study because they are the parents of a child
that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being
done and their child's body mass index has been at or above the 85th percentile.
The purpose of this pilot study is to assess the ease and acceptance of providing an
intervention for parents of children ages 2-5 years in the pediatric primary care clinic.
The purpose is to also assess how well the intervention works in improving the child's
dietary patterns.
Thirty (30) subjects will be enrolled across three (3) TCP clinics where the study will take
place. Two types of participants will be recruited for this study: parent participants who
will receive the intervention and interventionist participants who will deliver the
intervention.
Data collected for this study includes 4 types: parent-report questionnaires, parent saliva
samples, parent-report of children's 24-hour food recall, and audio-recordings of
intervention sessions. Parent-report questionnaires will assess family demographic
information, parental stress, depression, and well-being as well as parental feeding
practices and child dietary food patterns.
Procedures for Parent Participants:
Parents will be randomized to the intervention (Group A-15 parents) or control condition
(Group B-15 parents). Parents who are randomized to the intervention group will then
participate in the 10-session SSC program that is co-led by a trained parent
interventionist. Sessions will be audio-recorded to allow intervention fidelity checks.
Parents who are randomized to the control condition will receive the SSC written handouts,
which is enhanced standard of care for parents who are seen in primary care.
If subjects are assigned to Group A, they will participate in ten intervention sessions that
are conducted in the TCP clinic. During each session, subjects will be provided with
information about specific skills to improve their child's emotional health and dietary
patterns and their own stress levels.
If subjects are assigned to Group B, they will receive written handouts about children's
dietary patterns and parent stress levels. They will be instructed to write goals and
document goal progress. This care plan is the standard practice and is presently implemented
in the site's TCP clinics.
After ten weeks, regardless of the group the subjects were assigned to, they will again
complete an interview about their child's dietary food patterns and questionnaires about
their own emotions/opinions of their parenting and child feeding practices. The subjects
will also be asked to collect their saliva at four time points on a single day at home.
Procedures for Interventionist Participants:
Six interventionist participants will be recruited. Those who indicate interest will meet
with the PI or a research staff member to obtain consent. They will then receive 40-hours of
training in the intervention provided by study staff. Intervention participants will deliver
one or more group intervention, which has 10 sessions.
place. Two types of participants will be recruited for this study: parent participants who
will receive the intervention and interventionist participants who will deliver the
intervention.
Data collected for this study includes 4 types: parent-report questionnaires, parent saliva
samples, parent-report of children's 24-hour food recall, and audio-recordings of
intervention sessions. Parent-report questionnaires will assess family demographic
information, parental stress, depression, and well-being as well as parental feeding
practices and child dietary food patterns.
Procedures for Parent Participants:
Parents will be randomized to the intervention (Group A-15 parents) or control condition
(Group B-15 parents). Parents who are randomized to the intervention group will then
participate in the 10-session SSC program that is co-led by a trained parent
interventionist. Sessions will be audio-recorded to allow intervention fidelity checks.
Parents who are randomized to the control condition will receive the SSC written handouts,
which is enhanced standard of care for parents who are seen in primary care.
If subjects are assigned to Group A, they will participate in ten intervention sessions that
are conducted in the TCP clinic. During each session, subjects will be provided with
information about specific skills to improve their child's emotional health and dietary
patterns and their own stress levels.
If subjects are assigned to Group B, they will receive written handouts about children's
dietary patterns and parent stress levels. They will be instructed to write goals and
document goal progress. This care plan is the standard practice and is presently implemented
in the site's TCP clinics.
After ten weeks, regardless of the group the subjects were assigned to, they will again
complete an interview about their child's dietary food patterns and questionnaires about
their own emotions/opinions of their parenting and child feeding practices. The subjects
will also be asked to collect their saliva at four time points on a single day at home.
Procedures for Interventionist Participants:
Six interventionist participants will be recruited. Those who indicate interest will meet
with the PI or a research staff member to obtain consent. They will then receive 40-hours of
training in the intervention provided by study staff. Intervention participants will deliver
one or more group intervention, which has 10 sessions.
Inclusion Criteria for Parent Participants:
- Non-Latino African American or Latino parents/primary caregivers (defined as primary
guardian, which may include legal guardians and foster parents) of a child patient
(ages 2-5 years) at Texas Children's Pediatrics (TCP) Community Care medical
practices (Gulfgate, Cullen, and Corinthian Pointe)
- Parents of children with a body mass index (BMI) of greater than 85th and less than
95th percentile (overweight) and greater than 95th percentile (obese)
- English as the primary household language
Inclusion Criteria for Interventionist Participants:
- Non-Latino African American or Latino, 18 years or older, having a GED/high school
diploma, and parent of a young child
Exclusion Criteria for Parent Participants:
- Parents of children with any type of food allergy, parents of children receiving
current intervention for weight
- Parents of children with weight-related medical conditions (e.g., Prader-Willi
Syndrome)
- Parents of children who are taking medication (e.g.,stimulant) associated with
appetite
Exclusion Criteria for Parent Participants:
We found this trial at
2
sites
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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