Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment.
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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 description: 
      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 their primary
      provider. The Healthy Lifestyles clinical protocol has been described elsewhere. In short,
      children aged 22 years and under with BMI ≥ 95th percentile are referred by their primary
      physician to the multidisciplinary HL clinic for treatment of obesity and related
      co-morbidities. The intervention involves monthly visits for one year to meet with medical,
      dietary, exercise and behavior specialists all certified in Motivational Interviewing.
      Despite the comprehensive model, and despite consistent delivery of behavior change
      counseling using motivational interviewing, the Healthy Lifestyles model does not lead to
      significant decreases in body mass index. Less than 25% of patients who initially enroll
      complete treatment. These outcomes are similar to other comprehensive child obesity programs
      nationally. There is a clear need for effective treatment options.

      A rapidly evolving field of study is investigating the use of healthcare provider-to-text
      messages to augment patient behavior change. Text messaging is attractive, in part, because
      text penetrance to mixed ethnic, racial, and socioeconomic populations is high, and 80-81% of
      sent messages are read with a mean response time of 6 minutes. Text messages as simple
      reminders can lead to improvements in patient compliance with medications and immunizations.
      Text messages targeting behaviors can decrease TV viewing time among young children when
      texts are delivered to the parent. Text messages can also improve self-efficacy when they
      offer encouragement, recognize the difficulty of change, and congratulate the patient on
      change. To date, no studies have investigated the use of provider-to-parent text messages
      utilizing MI theory to increase the effectiveness of childhood obesity treatment.

      Design A randomized, controlled, non-blinded clinical trial design will be utilized. The
      study team will identify qualifying parents as they arrive for their child's first scheduled
      clinic appointment to the Duke Healthy Lifestyles Program. The team has previously obtained
      IRB approval to approach Healthy Lifestyles families who qualify for research studies
      (Healthy Lifestyles Notification of Research, PRO00031251).

      Study interventions A trained research assistant will collect all measures as described
      below, either through chart review or direct questioning of the parent. A registered nurse
      will collect the food recall measure (USDA) and perform the 3-minute step test; both are in
      accordance with current clinical protocol. Subjects will be randomized to the intervention or
      control group using a random number generator (Excel, 2010). Subjects randomized to the
      control group will receive usual care, which includes a lifestyle counseling visit,
      educational materials, and goal-setting by a physician and dietician, with follow up in 1
      month. Subjects randomized to the intervention group will receive usual care as above PLUS
      daily text messages on their designated mobile device for four weeks. The content of the
      messages will provide information to parents on general health behaviors and offer supportive
      guidance. Text messages will be delivered through the use of an application (GoogleVoice)
      that is accessible to the investigator on a mobile or web-based system. The text message will
      be delivered directly to the parent's message inbox, and does not require the parent to
      download any software or applications. Patients may opt-out at any time by replying STOP to a
      text message. Rules for texting and opt-out instructions will be provided in writing.
      Subjects will be permitted to respond to the PI text. Subjects will be informed that the PI
      is not able to answer any medical, appointment, or treatment questions, and if asked, will
      reply with the office phone number for appropriate triage. An appointment reminder for the
      follow up visit will be texted to both intervention and control groups 2 days prior to the
      scheduled visit. Subjects will repeat a subset of measures at the time of presentation for
      care at the HL clinic at the follow up visit, or if they do not present for care, will be
      contacted by phone to complete the follow up measures.
    

Intervention name(s): Lifestyle counseling; Text Messaging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): see arm description; See Arm Description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child obesity; childhood obesity; obesity treatment; text messaging; Lifestyle