Text4Fit: Healthcare Text Messaging to Improve Diet, Physical Activity and Weight Loss in a Pediatric Lipid Clinic

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02228278

Collaborator

(none)

148

Enrollment

Locations

Arms

46.5

Actual Duration (Months)

49.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity	Behavioral: Group A Other: Group B	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Text 4 Fit Project: Healthcare Text Messaging to Improve Health Outcomes and Medication Compliance in Overweight and Obese Adolescents.

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Feb 15, 2019

Actual Study Completion Date :

Feb 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Group A will receive the typical clinic visits plus daily text messages	Behavioral: Group A Phase 1: Group A will receive the typical clinic visits plus daily text messages for 12 weeks. Phase 2: Group A 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 provide) plus daily text messages in between visits for 3 months to support their health goals.
Other: Group B Group B will act as the control and will receive the typical clinic visits.	Other: Group B Phase 1: Group B 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. Phase 2: 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.

Arm

Intervention/Treatment

Experimental: Group A

Group A will receive the typical clinic visits plus daily text messages

Behavioral: Group A

Phase 1: Group A will receive the typical clinic visits plus daily text messages for 12 weeks. Phase 2: Group A 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 provide) plus daily text messages in between visits for 3 months to support their health goals.

Other: Group B

Group B will act as the control and will receive the typical clinic visits.

Other: Group B

Phase 1: Group B 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. Phase 2: 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.

Outcome Measures

Primary Outcome Measures

Feasibility and Acceptability of text message intervention (Phase 1) [Change in baseline and 3 months]
This will involve a pre-study interview with a small group of subjects to assess for their opinions on the text messages and study concept. Following this, we will perform a small scale trial of the program, involving 20 participants with 10 subjects in the intervention group and 10 controls. The number of participants will most likely not be adequate to reach statistical significance in detecting differences in healthy food choices, physical activity and BMI z-score between control and experimental groups. However, this study will help guide us in establishing if this healthcare texting system functions well. In addition, it may help determine if there are any trends in improvement of the target variables that would support the need for a future, larger study.

Secondary Outcome Measures

Changes from baseline proportion of healthy food choices versus unhealthy choices [Change in baseline, 3 and 6 months]
Phase 1: We aim to have our adolescent subjects fill out a Schwartz Diet and Activity History at time points 0, 3 and 6 months. We will assess their baseline food choices and then assess for changes in food habits over time, with a prediction that this text message communication will help to decrease the "negative" food choices (sugars/syrups, non whole grain starches, processed foods, sugar sweetened beverages) and increase the "positive" food (fruits/vegetables, low fat dairy, water) choices by 10% (based on screener scores pre and post intervention). Phase 2: Each participant will complete a Block Food Screener and Block Physical Activity Screener, instead of the Schwartz Diet and Activity History, to assess the proportion of healthy food choices versus unhealthy choices.
Changes from baseline time spent doing physical activity [Change in baseline, 3 and 6 months]
Phase 1: We aim to have our adolescent subjects complete a Schwartz Diet and Activity History at time points 0, 3 and 6 months. We will assess their baseline physical activity and then assess for changes in physical activity over time, with a prediction that this text message communication will help to decrease their sedentary time (and TV time) and increase their physical activity by 10% (based on screener scores pre and post intervention). Phase 2: Each participant will complete a Block Physical Activity Screener, instead of the Schwartz Diet and Activity History, to assess physical activity
Changes from baseline BMI Z-score [Change in baseline, 3 months and 6 months]
Subjects will have assessments of height, weight, age and sex at 0, 3 and 6 month clinic visits. Researchers will assess for any changes in BMI Z-score across time points.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic	Gainesville	Florida	United States	32608
2	University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic	Gainesville	Florida	United States	32608
3	UF Health and Congenital Heart Center	Jacksonville	Florida	United States	32207

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Lindsay Thompson, MD, University of Florida Health Shands Children's Hospital
Study Director: Kristin A Dayton, MD, University of Florida Shands Children's Hospital