Pediatric Obesity Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
| Recruiting |
NCT06111040 -
Nurturing Needs Study: Parenting Food Motivated Children
|
N/A | |
| Completed |
NCT03036696 -
The BEACH Interview Study- Pregnant and Breastfeeding Mothers
|
||
| Completed |
NCT02959034 -
Pediatric Metabolism and Microbiome Repository
|
||
| Not yet recruiting |
NCT02484612 -
Exercise Intensity and Appetite in Adolescents
|
N/A | |
| Completed |
NCT02545764 -
Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children
|
N/A | |
| Recruiting |
NCT02426346 -
A Scalable Weight Control Intervention for Adolescents
|
Phase 2 | |
| Completed |
NCT02160847 -
Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors
|
N/A | |
| Completed |
NCT01989065 -
Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment.
|
N/A | |
| Completed |
NCT02343588 -
A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
|
N/A | |
| Completed |
NCT02375490 -
Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres
|
N/A | |
| Completed |
NCT01908153 -
Taste Reward Processing in Pediatric Obesity
|
||
| Completed |
NCT02074332 -
Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing
|
N/A | |
| Completed |
NCT02086851 -
Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
|
N/A | |
| Terminated |
NCT00846521 -
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
|
Phase 4 | |
| Completed |
NCT01146314 -
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
|
N/A | |
| Completed |
NCT04164277 -
FirstStep2Health Intervention
|
N/A | |
| Withdrawn |
NCT04600648 -
Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
|
N/A | |
| Completed |
NCT04395430 -
A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19
|
N/A | |
| Completed |
NCT03139877 -
Pediatric Obesity Observational Prospective Trial
|