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

NCT02228278 | Completed

• 1 other identifier: IRB201400433
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

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.

Conditions

Pediatric Obesity

Keywords

Pediatric; Obesity; Overweight; Texting; Text message; SMS; Diet; Weight Loss; Nutrition; Physical activity; BMI z-score; BMI

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in baseline and 3 months

Secondary Outcomes (3)

• Changes from baseline proportion of healthy food choices versus unhealthy choices

  Change in baseline, 3 and 6 months

• Changes from baseline time spent doing physical activity

  Change in baseline, 3 and 6 months

• Changes from baseline BMI Z-score

  Change in baseline, 3 months and 6 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Behavioral: Group A

Group B

OTHER

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

Other: Group B

Interventions

Group A BEHAVIORAL

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 A

Group B OTHER

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.

Group B

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic

Gainesville, Florida, 32608, United States

Location

University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic

Gainesville, Florida, 32608, United States

Location

UF Health and Congenital Heart Center

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Overweight; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Lindsay Thompson, MD

  University of Florida Health Shands Children's Hospital

  PRINCIPAL INVESTIGATOR

• Kristin A Dayton, MD

  University of Florida Shands Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 29, 2014
• Study Start: April 1, 2015
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)