search
Back to results

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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric, Obesity, Overweight, Texting, Text message, SMS, Diet, Weight Loss, Nutrition, Physical activity, BMI z-score, BMI

Eligibility Criteria

11 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic
  • University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic
  • UF Health and Congenital Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility and Acceptability of text message intervention (Phase 1)
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
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
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
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.

Full Information

First Posted
August 25, 2014
Last Updated
April 12, 2019
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT02228278
Brief Title
Healthcare Text Messaging to Improve Diet, Physical Activity and Weight Loss in a Pediatric Lipid Clinic
Acronym
Text4Fit
Official Title
Text 4 Fit Project: Healthcare Text Messaging to Improve Health Outcomes and Medication Compliance in Overweight and Obese Adolescents.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Pediatric, Obesity, Overweight, Texting, Text message, SMS, Diet, Weight Loss, Nutrition, Physical activity, BMI z-score, BMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A will receive the typical clinic visits plus daily text messages
Arm Title
Group B
Arm Type
Other
Arm Description
Group B will act as the control and will receive the typical clinic visits.
Intervention Type
Behavioral
Intervention Name(s)
Group A
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and Acceptability of text message intervention (Phase 1)
Description
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.
Time Frame
Change in baseline and 3 months
Secondary Outcome Measure Information:
Title
Changes from baseline proportion of healthy food choices versus unhealthy choices
Description
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.
Time Frame
Change in baseline, 3 and 6 months
Title
Changes from baseline time spent doing physical activity
Description
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
Time Frame
Change in baseline, 3 and 6 months
Title
Changes from baseline BMI Z-score
Description
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.
Time Frame
Change in baseline, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Thompson, MD
Organizational Affiliation
University of Florida Health Shands Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin A Dayton, MD
Organizational Affiliation
University of Florida Shands Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health and Congenital Heart Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs