Pediatric Obesity Clinical Trial
— HLP4UOfficial title:
Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment Through Provider-to-parent Text Messaging.
Verified date | December 2015 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy Lifestyles Program by delivering educational and supportive text messages to the parent's mobile device.
Status | Completed |
Enrollment | 101 |
Est. completion date | October 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Adult aged 18 or older and is the child's primary caregiver ("parent") - Child aged 5-12 years - Child with age- and gender-specific BMI = 95th percentile - Parent has mobile phone with texting plan Exclusion Criteria: - Inability to read and write in English - Parent with severe medical or mental health condition limiting ability to attend appointments - Plan to move out of state in next 3 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke Children's Health Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in child's Body Mass Index | Weight divided by the height squared. Gives indication of whether healthy lifestyle changes lead to short-term weight reduction. | Baseline and 3-month | No |
Primary | Food and Activity Frequency Survey Score | Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert. | 3 month post-enrollment | No |
Secondary | General Self-Efficacy Survey Score | Validated survey measures parental general self-efficacy. 10 questions on a 5-point Likert. | 3 month post-enrollment | No |
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