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

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.

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