Clinical trial NCT02674828: Physical Activity and Glycemic Control in Adolescents
Official title: Physical Activity and Glycemic Control in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Specific aims are:

1. To determine if the reinforcement intervention increases walking. The proportion of days on which participants meet walking goals will be assessed via Fitbit, a commercially available activity monitor, as well as continuous weeks on which goals are met. The hypothesis is that patients assigned to the reinforcement intervention will meet walking goals on a higher proportion of days and have longer durations of meeting walking goals than patients assigned to standard care.
2. To assess if the intervention reduces A1c. Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c than patients in usual care.

In addition to the primary aims, secondary outcomes will also be evaluated. The intervention is expected to enhance subjective and objective indices of fitness, increase quality of life, improve indices of diabetes management and decrease depression symptoms. Predictors of response to treatment will also be evaluated.

Results from this pilot study will be instrumental for guiding a subsequent, larger and longer term randomized study for evaluating reinforcement interventions for improving outcomes of youth and young adults with T1D.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: proportion of days participants walked the recommended number of steps
timeFrame: 12 weeks
measure: proportion of days in the month participants walked 10,000 or more steps
timeFrame: 24 weeks
measure: number of consecutive weeks step goal met
timeFrame: 12 weeks
Secondary outcomes:
measure: proportion of days participants walked the recommended number of steps
timeFrame: Baseline
measure: proportion of days participants walked the recommended number of steps
timeFrame: 6 weeks
measure: proportion of days participants walked the recommended number of steps
timeFrame: 24 weeks
measure: proportion of days in the month participants walked 10,000 or more steps
timeFrame: Baseline
measure: proportion of days in the month participants walked 10,000 or more steps
timeFrame: 6 weeks
measure: proportion of days in the month participants walked 10,000 or more steps
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: Baseline
measure: Body Mass Index
timeFrame: 6 weeks
measure: Body Mass Index
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 24 weeks
measure: Waist Circumference
timeFrame: Baseline
measure: Waist Circumference
timeFrame: 6 weeks
measure: Waist Circumference
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 24 weeks
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: 6 weeks
measure: Systolic Blood Pressure
timeFrame: 12 weeks
measure: Systolic Blood Pressure
timeFrame: 24 weeks
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: 6 weeks
measure: Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Diastolic Blood Pressure
timeFrame: 24 weeks
measure: Six Minute Walk Test
timeFrame: 12 weeks
measure: Sit to Stand Test
timeFrame: 12 weeks
measure: Harvard Step Test
timeFrame: Baseline
measure: Harvard Step Test
timeFrame: 6 weeks
measure: Harvard Step Test
timeFrame: 12 weeks
measure: Harvard Step Test
timeFrame: 24 weeks
measure: Physical Activity Questionnaire
timeFrame: Baseline
measure: Physical Activity Questionnaire
timeFrame: 6 weeks
measure: Physical Activity Questionnaire
timeFrame: 12 weeks
measure: Physical Activity Questionnaire
timeFrame: 24 weeks
measure: Habitual Total Weekend Activity Score
timeFrame: Baseline
measure: Habitual Total Weekend Activity Score
timeFrame: 6 weeks
measure: Habitual Total Weekend Activity Score
timeFrame: 12 weeks
measure: Habitual Total Weekend Activity Score
timeFrame: 24 weeks
measure: Habitual Total Weekday Activity Score
timeFrame: Baseline
measure: Habitual Total Weekday Activity Score
timeFrame: 6 weeks
measure: Habitual Total Weekday Activity Score
timeFrame: 12 weeks
measure: Habitual Total Weekday Activity Score
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: William Tamborlane
role: PRINCIPAL_INVESTIGATOR
References: