Childhood Obesity Prevention Program for Hispanics
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ClinicalTrials.gov Identifier: NCT01156402 |
Recruitment Status
:
Completed
First Posted
: July 2, 2010
Last Update Posted
: May 6, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Childhood Obesity | Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 319 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | May 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Active Intervention: Obesity Prevention |
Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health
The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.
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Experimental: Alternative Intervention/control: Oral Health |
Behavioral: Healthy Families-Childhood Obesity Prevention and Oral Health
The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.
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- Body Mass Index (BMI)-for-age percentile [ Time Frame: one year ]
- Child eating behaviors [ Time Frame: One year ]
- Child physical activity (accelerometers) [ Time Frame: One year ]
- Parenting strategies [ Time Frame: One year ]
- parent physical activity [ Time Frame: one year ]

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Ages Eligible for Study: | 5 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Children:
- 5-7 year-old female or male of Hispanic origin (identified by parent)
- resident of Davidson County or adjacent counties
- ≥25th percentile of age- and sex-specific BMI (CDC growth charts) or one parent/caregiver with BMI ≥ 25 kg/m2
- More than one child may enroll per family
Parents:
- Hispanic origin (self-identified)
- Spanish speaker
- adult age 18 or older
- parent of at least one eligible child
- Only one parent per family may enroll as a study participant and respond to questionnaires
Exclusion Criteria:
Children:
- BMI ≥ 35 kg/m2
- Medical conditions affecting growth
- Conditions limiting participation in the interventions or measurements
- Taking medications affecting growth
- No consent or inability to understand informed consent
- Incomplete or missed baseline assessments
- Plan to move from geographic area within the next 12 months.
Parents:
- No exclusions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156402
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37203 | |
Meharry Medical College | |
Nashville, Tennessee, United States, 37208 |
Publications:
Responsible Party: | Meharry Medical College |
ClinicalTrials.gov Identifier: | NCT01156402 History of Changes |
Other Study ID Numbers: |
030425PC062 03 (Meharry IRB) |
First Posted: | July 2, 2010 Key Record Dates |
Last Update Posted: | May 6, 2016 |
Last Verified: | May 2016 |
Keywords provided by Meharry Medical College:
Obesity Pediatric Obesity |
Additional relevant MeSH terms:
Obesity Pediatric Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |