Clinical trial NCT02228278: Healthcare Text Messaging to Improve Diet, Physical Activity and Weight Loss in a Pediatric Lipid Clinic
Official title: Text 4 Fit Project: Healthcare Text Messaging to Improve Health Outcomes and Medication Compliance in Overweight and Obese Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Pediatric
Obesity
Overweight
Texting
Text message
SMS
Diet
Weight Loss
Nutrition
Physical activity
BMI z-score
BMI
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 148
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if health-related text messages sent from healthcare providers to overweight and obese adolescents enrolled at a pediatric lipid clinic will result in increased adherence to their nutrition and physical activity goals and improve their weight loss. The study will also assess if the volume of texts per week impacts outcomes.

Detailed description: Phase 1: We will recruit 5 participants the from the UF Pediatric Lipid and Obesity clinic for pre-intervention cognitive interviewing to assess acceptability of the intervention and request their input on a representative sample of text messages. Then, 20 participants will be recruited from the same clinic for the intervention (10 controls, 10 intervention participants). Controls will receive current standard care - clinic visits every three months anthropometric assessments and counseling on physical activity and nutrition goals by a healthcare provider, typically with no patient-provider communication between visits. The intervention group will receive the typical clinic visits plus daily text messages in between visits with fitness and nutrition messages to support their health goals. All participants will have anthropometric measurements at baseline, 3 and 6 months. Each participant will complete a Schwartz Diet and Activity History at 0, 3 and 6 month visits, and a post intervention survey will be completed at the 3 month time point.

Phase 2: The second phase will be a larger scale study to assess for statistically significant effects of the text messaging intervention. One hundred participants will be recruited from the UF Pediatric Lipid and Obesity Clinic, one hundred from the UF Pediatric Headache Clinic and one hundred from the Congenital Heart Center for a total of three hundred (n=300) participants at three clinic locations. Participants will be randomized at each clinic location to one of two groups, Group A (immediate intervention, n=50) or Group B (control group, delayed intervention, n=50).

Participants randomized to Group A will receive the typical clinic visits (which includes anthropometric measures every three months, counselling on physical activity and nutrition goals by a healthcare provider and for those prescribed medication for a chronic condition, medication counseling by a healthcare provide) plus daily text messages in between visits for 3 months to support their health goals. Group B will initially act as the control and will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider, and for those prescribed medication for a chronic condition, medication counseling by a healthcare provider) with typically with no patient-provider communication between visits. After a 6-month delay, Group B will then receive the intervention which includes the typical clinic visits as stated previously plus daily text messages in between visits for 3 months to support their health goals. Participants will be seen in clinic at standard intervals for routine follow up (typically every 3 months). Three months after participants finish receiving the text messages, the same anthropometric and medication measures (for those prescribed chronic medication) that were collected at baseline as part of routine care will be repeated. Each participant will complete a Block Food Screener and Block Physical Activity Screener at 0, 3, and 6 months. A post-intervention survey will be completed after the participants have stopped receiving text messages.

Eligibility criteria: Phase 1:

Inclusion Criteria:

* Adolescents age 13-17
* Overweight or obese (BMI \> 85th percentile)
* Attend or will start attending UF Pediatric Lipid Clinic during the study period
* Own a cell phone that can receive text messages

Exclusion Criteria:

* Current diagnosis of a psychiatric eating disorder (anorexia nervosa or bulimia)
* Pregnancy
* Medical disease that would contraindicate moderate physical activity, as determined by clinician (MD or NP) from the Lipid Clinic

Phase 2:

Inclusion criteria

* Ages 11-21
* Overweight or obese (BMI \> 85th percentile)
* Attend or will start attending UF Health Pediatric Lipid and Obesity Clinic,UF Health Pediatric Headache Clinic or UF Health Congenital Heart Center during the study period
* Own a cell phone that can receive text messages (or parent owns a cell phone that can receive text messages)

Exclusion criteria

* Current diagnosis of a psychiatric eating disorder (anorexia nervosa or bulimia)
* Pregnancy
* Medical disease that would contraindicate moderate physical activity

Primary outcomes:
measure: Feasibility and Acceptability of text message intervention (Phase 1)
timeFrame: Change in baseline and 3 months
Secondary outcomes:
measure: Changes from baseline proportion of healthy food choices versus unhealthy choices
timeFrame: Change in baseline, 3 and 6 months
measure: Changes from baseline time spent doing physical activity
timeFrame: Change in baseline, 3 and 6 months
measure: Changes from baseline BMI Z-score
timeFrame: Change in baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic
state: Florida
city: Jacksonville
country: United States
facility: UF Health and Congenital Heart Center
state: Florida
Study officials:
affiliation: University of Florida Health Shands Children's Hospital
name: Lindsay Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida Shands Children's Hospital
name: Kristin A Dayton, MD
role: STUDY_DIRECTOR
References: