Clinical Trial: Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment Through Provider-to-parent Text Messaging.

Brief Summary: 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.

Detailed Summary:

Protocol Title Healthy Lifestyles Program for You (HLP4U): Augmenting childhood obesity treatment through provider-to-parent text messaging.

Significance One in three children in the US are overweight or obese, a condition known to increase the risk of adult obesity and chronic disease. Behavioral treatment of pediatric and adolescent obesity is strongly recommended, and in research settings treatment has shown efficacy in reduction of child body mass index (BMI) and improved long-term health outcomes. However, clinical treatment models must operate within the constraints of the outpatient practice, and are limited in their ability to deliver the same intensity of intervention or outreach. Not surprisingly, clinic-based treatment of child obesity is less effective than in research settings.

"Motivational Interviewing" (MI) has emerged as a promising clinical method for improving health outcomes in childhood obesity treatment. "Motivation" is defined as an individual's expressed intention to change, and is divided into three measurable elements: importance, confidence, and readiness. The theoretical framework of MI focuses on the interpersonal aspects of behavioral change between patient and provider. MI emphasizes provider empathy, support for patient autonomy, exploring ambivalence and reinforcing change talk. Several studies have demonstrated that childhood obesity treatments that use MI effectively are more likely to achieve improved child outcomes than those who do not. These outcomes include decreased BMI,6 increased physical activity, and improvements in parental confidence.

The Healthy Lifestyles (HL) program is an AAP Stage 2-4 childhood obesity program3 located in Durham, NC. Children with BMI above the 95th percentile are referred to HL by thei
Sponsor: Duke University

Current Primary Outcome: Food and Activity Frequency Survey Score [ Time Frame: 3 month post-enrollment ]

Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert.


Original Primary Outcome: Family Nutrition and Physical Activity Survey Score [ Time Frame: 1 month post-enrollment ]

Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert.


Current Secondary Outcome: General Self-Efficacy Survey Score [ Time Frame: 3 month post-enrollment ]

Validated survey measures parental general self-efficacy. 10 questions on a 5-point Likert.


Original Secondary Outcome: General Self-Efficacy Survey Score [ Time Frame: 1 month post-enrollment ]

Validated survey measures parental general self-efficacy. 10 questions on a 5-point Likert.


Information By: Duke University

Dates:
Date Received: November 14, 2013
Date Started: September 2014
Date Completion:
Last Updated: December 1, 2015
Last Verified: December 2015