N/A
N=40
iStart Smart for Teens for Healthy Weight Management
Overweight · Obese
Bottom Line
View on ClinicalTrials.gov: NCT01693250 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Body Mass Index (BMI) — 27.37; 28.35; 26.93; 29.18 kg/m^2 — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fitbit Ultra (Behavioral); Pedometer (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (BMI) |
27.37; 28.35; 26.93; 29.18 | <.001 sig |
Summary
The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the increased prevalence of childhood obesity in the last two decades. Obesity during the adolescent years is associated with many adverse health consequences, including T2DM, hyperlipidemia, and psychosocial problems. The first step toward effective obesity management and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the rapid expansion of cellular networks, and advancements in smartphone technologies, it is now possible to monitor PA and dietary intake and at the same time to transmit data digitally to their primary care providers (PCP). The proposed pilot study will include the collaboration among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese adolescents. The study will adapt and implement smartphone-based technologies and integrate these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake. Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid profile), at 3 months post intervention between the intervention and control groups. The smartphone app for the intervention group will allow the teens to graphically compare daily PA and dietary intake with the goal, participate in a reward program where they can collect virtual points for achieving the goal, and play interactive games related to PA and diet. A total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to the feasibility study (Aim 2).
Eligibility Criteria
Inclusion Criteria
- between 13-18 years old
- have a BMI at ≥ 85th percentile, based on CDC growth chart
- own a smartphone;
- have access to a computer with internet access
- be able to read and speak English.
Exclusion Criteria
- have acute or life-threatening disease
- not be able to engage in activities of daily living
Data sourced from ClinicalTrials.gov (NCT01693250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.