Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-04 @ 9:52 AM
Study NCT ID:
NCT02579395
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2015-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2 Diabetes (T2D) will be randomly assigned to either the collaborative implementation intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs) condition, or the control condition. As this is a pilot study, randomization for the experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental conditions will contain up to 36 participants and the control condition will contain up to 18 participants. Adults with T2D who are living with a romantic partner, not meeting current physical activity guidelines but able and willing to begin a new physical activity (PA) routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the experimental manipulation. Partners will report on their own investment in the patient's goal and patients will report on their own PA self-efficacy. Patient's PA will be measured through self-report, partner report and accelerometers for a week prior to each survey assessment. These specific aims are planned:
AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in partner investment in partners of adults with T2D than do individual IIs or control.
AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA self-efficacy in adults with T2D than do individual IIs or control.
AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA in adults with T2D than do individual IIs or control.
AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in partner investment in partners of adults with T2D than do individual IIs or control.
AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA self-efficacy in adults with T2D than do individual IIs or control.
AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA in adults with T2D than do individual IIs or control.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: