The Role of Activity Tracking on Weight Loss in Obese Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.
Study Overview
Brief Summary
This study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. The investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.
Detailed Description
This study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. The investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. Each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition
Exclusion Criteria
- •Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English
Arms & Interventions
Control
Participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.
Intervention
Fitbit (activity tracker) + participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.
Intervention: Activity Tracker (Behavioral)
Outcomes
Primary Outcomes
Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.
Time Frame: 18 weeks
We set a study attrition rate of participants at ≤50% as the feasibility measure for the study.
Secondary Outcomes
- Body mass index (BMI) (kg/m2)(Change from 0 to 18 weeks)
- Weight (kg)(Change from 0 to 18 weeks)
- Change in obesity related biomarkers(Change from 0 to 18 weeks)