Physical Activity and Glycemic Control in Adolescents

NCT02674828 | Completed

• 2 other identifiers: 1509016461DP3DK097705
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 weeks

Secondary Outcomes (40)

• proportion of days participants walked the recommended number of steps

  Baseline

• proportion of days participants walked the recommended number of steps

  6 weeks

• proportion of days participants walked the recommended number of steps

  24 weeks

• proportion of days in the month participants walked 10,000 or more steps

  Baseline

• proportion of days in the month participants walked 10,000 or more steps

  6 weeks

Study Arms (2)

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.

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.

Other: Standard of Care

Interventions

Reinforcement for meeting targeted physical activity goals 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.

Reinforcement treatment

Standard of Care 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.

Reinforcement treatment; Standard Treatment

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William Tamborlane

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 5, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)