Pediatric ObesityText4FitNCT02228278
Healthcare Text Messaging to Improve Diet, Physical Activity and Weight Loss in a Pediatric Lipid Clinic
A study testing Group A and Group B in people with Pediatric Obesity, run by University of Florida at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Group A and Group B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- 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)
Who cannot join
- 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:
- Current diagnosis of a psychiatric eating disorder (anorexia nervosa or bulimia)
- Pregnancy
- Medical disease that would contraindicate moderate physical activity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic
Gainesville, Florida, 32608
University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic
Gainesville, Florida, 32608
UF Health and Congenital Heart Center
Jacksonville, Florida, 32207
About this study
Official title: Text 4 Fit Project: Healthcare Text Messaging to Improve Health Outcomes and Medication Compliance in Overweight and Obese Adolescents.
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Group A, Group B
- Keywords
- Pediatric, Obesity, Overweight, Texting, Text message, SMS, Diet, Weight Loss, Nutrition, Physical activity, BMI z-score, BMI
- Medical subject headings
- Pediatric Obesity, Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABehavioural
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.
Group BOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will receive the typical clinic visits plus daily text messages Receives: Behavioral: Group A |
| Group B | Other | Group B will act as the control and will receive the typical clinic visits. Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in baseline and 3 months
Secondary outcomes (3)
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.
Measured: Change in baseline, 3 and 6 months
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
Measured: Change in baseline, 3 and 6 months
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.
Measured: Change in baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startApr 2015
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay Thompson, MD, Principal investigator, University of Florida Health Shands Children's HospitalKristin A Dayton, MD, Study director, University of Florida Shands Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228278
- Sponsor's protocol ID
- IRB201400433
- Acronym
- Text4Fit
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text 4 Fit Project: Healthcare Text Messaging to Improve Health Outcomes and Medication Compliance in Overweight and Obese Adolescents.
- ClinicalTrials.gov ID
- NCT02228278
- Acronym / sponsor ID
- Text4Fit / IRB201400433
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric, Obesity, Overweight, Texting, Text message, SMS, Diet, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Group AGroup A will receive the typical clinic visits plus daily text messages |
| Group B | Other | Other: Group BGroup B will act as the control and will receive the typical clinic visits. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
- Ages 11-21
Key exclusion criteria (7 listed)
- 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
- Current diagnosis of a psychiatric eating disorder (anorexia nervosa or bulimia)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group APhase 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. | Behavioural | Group A |
| Group BPhase 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. | Other | Group B |
Primary outcome
Feasibility and Acceptability of text message intervention (Phase 1)
Time frame: 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.
3 secondary outcomes
Changes from baseline proportion of healthy food choices versus unhealthy choices
Time frame: Change in baseline, 3 and 6 months
Changes from baseline time spent doing physical activity
Time frame: Change in baseline, 3 and 6 months
Changes from baseline BMI Z-score
Time frame: Change in baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Thompson, MD principal investigator
University of Florida Health Shands Children's Hospital
Kristin A Dayton, MD study director
University of Florida Shands Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Pediatric Obesity, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability of text message intervention (Phase 1) (time frame: Change in baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.