Type 1 DiabetesNCT02674828
Physical Activity and Glycemic Control in Adolescents
A study testing Reinforcement for meeting targeted physical activity goals in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Reinforcement for meeting targeted physical activity goals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
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.
Read the detailed description
Specific aims are:
- 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.
- 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Reinforcement for meeting targeted physical activity goals, Standard of Care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement for meeting targeted physical activity goalsBehavioural
Participants in this condition will receive reinforcement for meeting targeted physical activity goals. These subjects will receive the same treatment as standard treatment group, including incentives for uploading/synching and discussions of ADA recommendations of managing diabetes in the context of physical activity. The only difference between conditions is that participants in this condition will earn tangible reinforcement for walking the target number of steps per day (6,000 per day in week 1, 8,000 per day in week 2 and 10,000 per day in weeks 3-12). At each upload, participants will earn incentives for each day on which they met the step goals. In addition, for each 7-day period in which they meet goals on at least 5 days, they will earn bonuses.
Standard of CareOther
Participants in the standard of care group will be told to wear Fitbit daily for 12 weeks. They will be instructed to upload or synch it >2x/week, on set days, e.g., Mon and Thurs, for the next 6 weeks and then weekly in the last 6 weeks. They will receive incentives for each upload, plus a bonus for each week in which data are registered for all 7 days in the week as scheduled. They will be encouraged to review Fitbit steps daily and on each upload/synch day. After each upload, research staff will congratulate patients via email or text for days on which they met goals, and encourage meeting goals in the upcoming week.
| Study group | Role | What they receive |
|---|---|---|
| Reinforcement treatment | Experimental | Participants in this condition will receive reinforcement for meeting targeted physical activity goals. These subjects will receive the same treatment as standard treatment group, including incentives for uploading/synching and discussions of ADA recommendations of managing diabetes in the context of physical activity. The only difference between conditions is that participants in this condition will earn tangible reinforcement for walking the target number of steps per day (6,000 per day in week 1, 8,000 per day in week 2 and 10,000 per day in weeks 3-12). At each upload, participants will earn incentives for each day on which they met the step goals. In addition, for each 7-day period in which they meet goals on at least 5 days, they will earn bonuses. Receives: Behavioral: Reinforcement for meeting targeted physical activity goals; Other: Standard of Care |
| Standard Treatment | Active comparator | Participants in the standard of care group will be told to wear Fitbit daily for 12 weeks. They will be instructed to upload or synch it >2x/week, on set days, e.g., Mon and Thurs, for the next 6 weeks and then weekly in the last 6 weeks. They will receive incentives for each upload, plus a bonus for each week in which data are registered for all 7 days in the week as scheduled. They will be encouraged to review Fitbit steps daily and on each upload/synch day. After each upload, research staff will congratulate patients via email or text for days on which they met goals, and encourage meeting goals in the upcoming week. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of days participants walked the recommended number of steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: 12 weeks
proportion of days in the month participants walked 10,000 or more steps
Long-term outcome will be proportion of days in the month before the 24-week follow up on which participants walked 10,000 or more steps.
Measured: 24 weeks
number of consecutive weeks step goal met
The number of weeks in a row in which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: 12 weeks
Secondary outcomes (40)
proportion of days participants walked the recommended number of steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: Baseline
proportion of days participants walked the recommended number of steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: 6 weeks
proportion of days participants walked the recommended number of steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: 24 weeks
proportion of days in the month participants walked 10,000 or more steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: Baseline
proportion of days in the month participants walked 10,000 or more steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: 6 weeks
proportion of days in the month participants walked 10,000 or more steps
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
Measured: 12 weeks
Body Mass Index
Body mass index (BMI) will be used as an indicator of physical activity and fitness. BMI will be calculated from height (assessed in stocking feet and measured to the nearest 0.10 cm) and weight (with excessive clothing, keys, wallets etc removed) and measured to the nearest 0.10 kg. BMI is weight in kg/height in m2. BMI range of > 0 to 40kg/m2. Higher BMI is perceived as unhealthy.
Measured: Baseline
Body Mass Index
Body mass index (BMI) will be used as an indicator of physical activity and fitness. BMI will be calculated from height (assessed in stocking feet and measured to the nearest 0.10 cm) and weight (with excessive clothing, keys, wallets etc removed) and measured to the nearest 0.10 kg. BMI is weight in kg/height in m2. BMI range of > 0 to 40kg/m2. Higher BMI is perceived as unhealthy.
Measured: 6 weeks
Body Mass Index
Body mass index (BMI) will be used as an indicator of physical activity and fitness. BMI will be calculated from height (assessed in stocking feet and measured to the nearest 0.10 cm) and weight (with excessive clothing, keys, wallets etc removed) and measured to the nearest 0.10 kg. BMI is weight in kg/height in m2. BMI range of > 0 to 40kg/m2. Higher BMI is perceived as unhealthy.
Measured: 12 weeks
Body Mass Index
Body mass index (BMI) will be used as an indicator of physical activity and fitness. BMI will be calculated from height (assessed in stocking feet and measured to the nearest 0.10 cm) and weight (with excessive clothing, keys, wallets etc removed) and measured to the nearest 0.10 kg. BMI is weight in kg/height in m2. BMI range of > 0 to 40kg/m2. Higher BMI is perceived as unhealthy.
Measured: 24 weeks
Waist Circumference
Waist circumference (WC) will be used as an indicator of physical activity and fitness. WC is measured at the height of the iliac crest with a Gulick tape measure to the nearest cm. Range is not applicable, but circumference will be > 0. A higher waist circumference is perceived as a negative outcome.
Measured: Baseline
Waist Circumference
Waist circumference (WC) will be used as an indicator of physical activity and fitness. WC is measured at the height of the iliac crest with a Gulick tape measure to the nearest cm. Range is not applicable, but circumference will be > 0. A higher waist circumference is perceived as a negative outcome.
Measured: 6 weeks
Waist Circumference
Waist circumference (WC) will be used as an indicator of physical activity and fitness. WC is measured at the height of the iliac crest with a Gulick tape measure to the nearest cm. Range is not applicable, but circumference will be > 0. A higher waist circumference is perceived as a negative outcome.
Measured: 12 weeks
Waist Circumference
Waist circumference (WC) will be used as an indicator of physical activity and fitness. WC is measured at the height of the iliac crest with a Gulick tape measure to the nearest cm. Range is not applicable, but circumference will be > 0. A higher waist circumference is perceived as a negative outcome.
Measured: 24 weeks
Systolic Blood Pressure
Systolic blood pressure (SBP) will be used as an indicator of physical activity and fitness. SBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Range is not applicable, but reading will be > 0. Higher SBP values are perceived as negative.
Measured: Baseline
Systolic Blood Pressure
Systolic blood pressure (SBP) will be used as an indicator of physical activity and fitness. SBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Range is not applicable, but reading will be > 0. Higher SBP values are perceived as negative.
Measured: 6 weeks
Systolic Blood Pressure
Systolic blood pressure (SBP) will be used as an indicator of physical activity and fitness. SBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Range is not applicable, but reading will be > 0. Higher SBP values are perceived as negative.
Measured: 12 weeks
Systolic Blood Pressure
Systolic blood pressure (SBP) will be used as an indicator of physical activity and fitness. SBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Range is not applicable, but reading will be > 0. Higher SBP values are perceived as negative.
Measured: 24 weeks
Diastolic Blood Pressure
Diastolic blood pressure (DBP) will be used as an indicator of physical activity and fitness. DBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Longer distance in meters walked is perceived as good. Range is not applicable, but reading will be > 0. High DBP values are perceived as negative.
Measured: Baseline
Diastolic Blood Pressure
Diastolic blood pressure (DBP) will be used as an indicator of physical activity and fitness. DBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Longer distance in meters walked is perceived as good. Range is not applicable, but reading will be > 0. High DBP values are perceived as negative.
Measured: 6 weeks
Diastolic Blood Pressure
Diastolic blood pressure (DBP) will be used as an indicator of physical activity and fitness. DBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Longer distance in meters walked is perceived as good. Range is not applicable, but reading will be > 0. High DBP values are perceived as negative.
Measured: 12 weeks
Diastolic Blood Pressure
Diastolic blood pressure (DBP) will be used as an indicator of physical activity and fitness. DBP (mmHg) will be taken in seated position using a semi-automated noninvasive BP unit (e.g., Suntech, Raleigh, NC). After 5 min of seated rest, BP will be taken twice, 2 minutes apart in the non-dominant arm until two consecutive readings are within 5 mmHg and averaged. Longer distance in meters walked is perceived as good. Range is not applicable, but reading will be > 0. High DBP values are perceived as negative.
Measured: 24 weeks
Six Minute Walk Test
The six minute walk test (SMWT) will be used as an indicator of physical activity and fitness. SMWT records distance (in meters) that patients cover when walking indoors at their own pace for 6 min, timed by a standard stopwatch. Range is not applicable, but time will be > 0. Higher SMWT values are perceived as positive/good.
Measured: 12 weeks
Sit to Stand Test
The sit to stand test will be used as an indicator of physical activity and fitness. In the sit to stand test, the patient starts in a standing position and moves to the floor with buttocks to the ground and returns to standing as quickly as possible. Times (in seconds) from standing to standing, and from floor sitting to standing, are recorded, with best of 2 trials used. Range is not applicable, but time will be > 0. Higher scores are perceived as poor outcomes.
Measured: 12 weeks
Harvard Step Test
The modified Harvard Step Test will be used as an indicator of physical activity and fitness. After 5 min of rest, participants will be asked to step onto and down from a step 30 cm (11.8 inches) in height for 3 minutes at a rate of 30 steps per minute. Heart rate will be measured for 30 seconds at 1, 2 and 3 minutes after completion of stepping. A Physical Fitness Score [(duration of exercise in seconds x 100) / (sum of the three heart rates)] will be computed. Heart rate will be measured at 1, 2 and 3 minutes after completion of stepping. Harvard Step Test score = (duration of exercise in seconds x 100) / (sum of the three heart rates). Range is not applicable, but scores will be >0. Higher scores are perceived as good.
Measured: Baseline
Harvard Step Test
The modified Harvard Step Test will be used as an indicator of physical activity and fitness. After 5 min of rest, participants will be asked to step onto and down from a step 30 cm (11.8 inches) in height for 3 minutes at a rate of 30 steps per minute. Heart rate will be measured for 30 seconds at 1, 2 and 3 minutes after completion of stepping. A Physical Fitness Score [(duration of exercise in seconds x 100) / (sum of the three heart rates)] will be computed. Heart rate will be measured at 1, 2 and 3 minutes after completion of stepping. Harvard Step Test score = (duration of exercise in seconds x 100) / (sum of the three heart rates). Range is not applicable, but scores will be >0. Higher scores are perceived as good.
Measured: 6 weeks
Harvard Step Test
The modified Harvard Step Test will be used as an indicator of physical activity and fitness. After 5 min of rest, participants will be asked to step onto and down from a step 30 cm (11.8 inches) in height for 3 minutes at a rate of 30 steps per minute. Heart rate will be measured for 30 seconds at 1, 2 and 3 minutes after completion of stepping. A Physical Fitness Score [(duration of exercise in seconds x 100) / (sum of the three heart rates)] will be computed. Heart rate will be measured at 1, 2 and 3 minutes after completion of stepping. Harvard Step Test score = (duration of exercise in seconds x 100) / (sum of the three heart rates). Range is not applicable, but scores will be >0. Higher scores are perceived as good.
Measured: 12 weeks
Harvard Step Test
The modified Harvard Step Test will be used as an indicator of physical activity and fitness. After 5 min of rest, participants will be asked to step onto and down from a step 30 cm (11.8 inches) in height for 3 minutes at a rate of 30 steps per minute. Heart rate will be measured for 30 seconds at 1, 2 and 3 minutes after completion of stepping. A Physical Fitness Score [(duration of exercise in seconds x 100) / (sum of the three heart rates)] will be computed. Heart rate will be measured at 1, 2 and 3 minutes after completion of stepping. Harvard Step Test score = (duration of exercise in seconds x 100) / (sum of the three heart rates). Range is not applicable, but scores will be >0. Higher scores are perceived as good.
Measured: 24 weeks
Physical Activity Questionnaire
The International Physical Activity Questionnaire, Short Form (IPAQ) will be used as an indicator of physical activity and fitness. IPAQ assesses total physical activity in the previous 7 days. Questions measure the frequency (days per week) and duration (minutes per session) of physical activity, as well as its intensity level (vigorous, moderate, walking, or sitting). Participants are categorized into one of three physical activity levels (low, moderate, high) using algorithms provided in the IPAQ short form scoring protocol (www.ipaq.ki.se). Range is not applicable because it is a categorical variable. The high activity category is perceived as good.
Measured: Baseline
Physical Activity Questionnaire
The International Physical Activity Questionnaire, Short Form (IPAQ) will be used as an indicator of physical activity and fitness. IPAQ assesses total physical activity in the previous 7 days. Questions measure the frequency (days per week) and duration (minutes per session) of physical activity, as well as its intensity level (vigorous, moderate, walking, or sitting). Participants are categorized into one of three physical activity levels (low, moderate, high) using algorithms provided in the IPAQ short form scoring protocol (www.ipaq.ki.se). Range is not applicable because it is a categorical variable. The high activity category is perceived as good.
Measured: 6 weeks
Physical Activity Questionnaire
The International Physical Activity Questionnaire, Short Form (IPAQ) will be used as an indicator of physical activity and fitness. IPAQ assesses total physical activity in the previous 7 days. Questions measure the frequency (days per week) and duration (minutes per session) of physical activity, as well as its intensity level (vigorous, moderate, walking, or sitting). Participants are categorized into one of three physical activity levels (low, moderate, high) using algorithms provided in the IPAQ short form scoring protocol (www.ipaq.ki.se). Range is not applicable because it is a categorical variable. The high activity category is perceived as good.
Measured: 12 weeks
Physical Activity Questionnaire
The International Physical Activity Questionnaire, Short Form (IPAQ) will be used as an indicator of physical activity and fitness. IPAQ assesses total physical activity in the previous 7 days. Questions measure the frequency (days per week) and duration (minutes per session) of physical activity, as well as its intensity level (vigorous, moderate, walking, or sitting). Participants are categorized into one of three physical activity levels (low, moderate, high) using algorithms provided in the IPAQ short form scoring protocol (www.ipaq.ki.se). Range is not applicable because it is a categorical variable. The high activity category is perceived as good.
Measured: 24 weeks
Habitual Total Weekend Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: Baseline
Habitual Total Weekend Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: 6 weeks
Habitual Total Weekend Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: 12 weeks
Habitual Total Weekend Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: 24 weeks
Habitual Total Weekday Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: Baseline
Habitual Total Weekday Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: 6 weeks
Habitual Total Weekday Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: 12 weeks
Habitual Total Weekday Activity Score
Habitual Activity Estimation Scale (HAES) will be used as an indicator of physical activity and fitness. The HAES asks participants to break their day down into four time periods; wakeup to breakfast, end of breakfast to lunch, end of lunch to supper, and end of supper to bedtime and to breakdown the activity done in each time period into; inactive, somewhat inactive, somewhat active, and very active. The HAES is filled out for both a typical weekday and weekend day. Total number of hours per day spent in each of four activity categories (inactive, somewhat inactive, somewhat active, and very active) will be calculated. Total activity (hours per day somewhat active + hours per day very active) also will be calculated. Two total activity scores are calculated - 1 for the weekday and 1 for the weekend day. Total activity score = hours per day somewhat active + hours per day very active.Total activity range of 0 to 24. High total activity is perceived as good.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Sep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- William Tamborlane, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674828
- Sponsor's protocol ID
- 1509016461
- Other IDs
- DP3DK097705
- Status last verified
- Jul 2020
- First submitted
- 19 Jan 2016
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Glycemic Control in Adolescents
- ClinicalTrials.gov ID
- NCT02674828
- Acronym / sponsor ID
- 1509016461
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforcement treatment | Experimental | Behavioral: Reinforcement for meeting targeted physical activity goals, Other: Standard of CareParticipants in this condition will receive reinforcement for meeting targeted physical activity goals. These subjects will receive the same treatment as standard treatment group, including incentives for uploading/synching and discussions of ADA recommendations of managing diabetes in the context of physical activity. The only difference between conditions is that participants in this condition will earn tangible reinforcement for walking the target number of steps per day (6,000 per day in week 1, 8,000 per day in week 2 and 10,000 per day in weeks 3-12). At each upload, participants will earn incentives for each day on which they met the step goals. In addition, for each 7-day period in which they meet goals on at least 5 days, they will earn bonuses. |
| Standard Treatment | Active comparator | Other: Standard of CareParticipants in the standard of care group will be told to wear Fitbit daily for 12 weeks. They will be instructed to upload or synch it >2x/week, on set days, e.g., Mon and Thurs, for the next 6 weeks and then weekly in the last 6 weeks. They will receive incentives for each upload, plus a bonus for each week in which data are registered for all 7 days in the week as scheduled. They will be encouraged to review Fitbit steps daily and on each upload/synch day. After each upload, research staff will congratulate patients via email or text for days on which they met goals, and encourage meeting goals in the upcoming week. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinforcement for meeting targeted physical activity goalsParticipants in this condition will receive reinforcement for meeting targeted physical activity goals. These subjects will receive the same treatment as standard treatment group, including incentives for uploading/synching and discussions of ADA recommendations of managing diabetes in the context of physical activity. The only difference between conditions is that participants in this condition will earn tangible reinforcement for walking the target number of steps per day (6,000 per day in week 1, 8,000 per day in week 2 and 10,000 per day in weeks 3-12). At each upload, participants will earn incentives for each day on which they met the step goals. In addition, for each 7-day period in which they meet goals on at least 5 days, they will earn bonuses. | Behavioural | Reinforcement treatment |
| Standard of CareParticipants in the standard of care group will be told to wear Fitbit daily for 12 weeks. They will be instructed to upload or synch it >2x/week, on set days, e.g., Mon and Thurs, for the next 6 weeks and then weekly in the last 6 weeks. They will receive incentives for each upload, plus a bonus for each week in which data are registered for all 7 days in the week as scheduled. They will be encouraged to review Fitbit steps daily and on each upload/synch day. After each upload, research staff will congratulate patients via email or text for days on which they met goals, and encourage meeting goals in the upcoming week. | Other | Reinforcement treatment, Standard Treatment |
Primary outcome
proportion of days participants walked the recommended number of steps
Time frame: 12 weeks
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
proportion of days in the month participants walked 10,000 or more steps
Time frame: 24 weeks
Long-term outcome will be proportion of days in the month before the 24-week follow up on which participants walked 10,000 or more steps.
number of consecutive weeks step goal met
Time frame: 12 weeks
The number of weeks in a row in which the recommended number of steps was achieved on at least 5 of the 7 days.
40 secondary outcomes
proportion of days participants walked the recommended number of steps
Time frame: Baseline
proportion of days participants walked the recommended number of steps
Time frame: 6 weeks
proportion of days participants walked the recommended number of steps
Time frame: 24 weeks
proportion of days in the month participants walked 10,000 or more steps
Time frame: Baseline
proportion of days in the month participants walked 10,000 or more steps
Time frame: 6 weeks
proportion of days in the month participants walked 10,000 or more steps
Time frame: 12 weeks
Body Mass Index
Time frame: Baseline
Body Mass Index
Time frame: 6 weeks
Body Mass Index
Time frame: 12 weeks
Body Mass Index
Time frame: 24 weeks
Waist Circumference
Time frame: Baseline
Waist Circumference
Time frame: 6 weeks
Waist Circumference
Time frame: 12 weeks
Waist Circumference
Time frame: 24 weeks
Systolic Blood Pressure
Time frame: Baseline
Systolic Blood Pressure
Time frame: 6 weeks
Systolic Blood Pressure
Time frame: 12 weeks
Systolic Blood Pressure
Time frame: 24 weeks
Diastolic Blood Pressure
Time frame: Baseline
Diastolic Blood Pressure
Time frame: 6 weeks
Diastolic Blood Pressure
Time frame: 12 weeks
Diastolic Blood Pressure
Time frame: 24 weeks
Six Minute Walk Test
Time frame: 12 weeks
Sit to Stand Test
Time frame: 12 weeks
Harvard Step Test
Time frame: Baseline
Harvard Step Test
Time frame: 6 weeks
Harvard Step Test
Time frame: 12 weeks
Harvard Step Test
Time frame: 24 weeks
Physical Activity Questionnaire
Time frame: Baseline
Physical Activity Questionnaire
Time frame: 6 weeks
Physical Activity Questionnaire
Time frame: 12 weeks
Physical Activity Questionnaire
Time frame: 24 weeks
Habitual Total Weekend Activity Score
Time frame: Baseline
Habitual Total Weekend Activity Score
Time frame: 6 weeks
Habitual Total Weekend Activity Score
Time frame: 12 weeks
Habitual Total Weekend Activity Score
Time frame: 24 weeks
Habitual Total Weekday Activity Score
Time frame: Baseline
Habitual Total Weekday Activity Score
Time frame: 6 weeks
Habitual Total Weekday Activity Score
Time frame: 12 weeks
Habitual Total Weekday Activity Score
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Tamborlane principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforcement for meeting targeted physical activity goals in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of days participants walked the recommended number of steps (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.