Physical Activity and Glycemic Control in Adolescents

NCT ID: NCT02674828

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2017-09-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reinforcement treatment

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.

Group Type: EXPERIMENTAL

Reinforcement for meeting targeted physical activity goals

Intervention Type: BEHAVIORAL

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 Care

Intervention Type: OTHER

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.

Standard Treatment

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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.

Interventions

Reinforcement for meeting targeted physical activity goals

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.

Intervention Type: BEHAVIORAL

Standard of Care

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Tamborlane

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

DP3DK097705

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1509016461

Identifier Type: -

Identifier Source: org_study_id