Physical Activity and Glycemic Control in Adolescents
Completed · Not applicable
Conditions studied: Type 1 Diabetes
In brief
The purpose of this pilot study is to evaluate the initial efficacy of a reinforcement intervention to enhance physical activity levels in sedentary adolescents and young adults with type 1 diabetes (T1D). The intervention will reinforce patients for meeting physical activity goals, with escalating reinforcers provided when patients achieve continuous weeks of meeting goals. A 12-week trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus reinforcement.
Key facts
- Study ID
- NCT02674828
- Run by
- Yale University
- People needed
- 12
- Starts
- 2016-02-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2020-07-07
Who can join
Age: 13 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age 13-24 years old and live with a parent at least 4 days per week on average;
- diagnosis of type 1 diabetes >12 months via ADA guidelines;
- mean A1c>7.5% and <13% in the year before study entry, and most recent A1c >7.5% but <13%;
- check blood sugar at least 2 times per day on average;
- access to a computer or cell phone with Internet for uploading or synching activity monitoring data and text messaging or email capabilities to communicate with study staff
- currently walk at least 1,000 steps per day, but less than 6,000 steps per day on average as assessed on >11 days between baseline session 1 and baseline session 2
- English speaking, pass an informed consent quiz, and adequate knowledge of managing T1D
You may not qualify if…
- have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) or major visual impairment that would inhibit participation
- have a significant other medical condition that impacts diabetes management (e.g., eating disorder, rheumatoid arthritis, or other condition that requires steroid treatment) or a physical illness, injury or condition that may interfere with physical activity recommendations (e.g., joint, hip or back problems, uncontrolled hypertension, or BMI > 40 kg/m2)
- plan to switch insulin delivery mode (injection to pump or vice versa) in the next 6 months, or have recently switched
- participating in another clinical trial
- fail or is unable to upload or synch the activity meter at least 4 times during the baseline period
Where it is running
- Yale University School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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