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Clinical Trials/NCT02579395
NCT02579395
Completed
Not Applicable

A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes

University of Colorado, Denver1 site in 1 country80 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Collaborative Implementation Intentions
Sponsor
University of Colorado, Denver
Enrollment
80
Locations
1
Primary Endpoint
Objective Physical Activity via accelerometer
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
February 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 21 years of age
  • Able to read and understand English
  • Does not meet physical activity guidelines (\< 150 minutes of moderate-vigorous exercise per week) for the last 3 months\* (only required of one partner)
  • Diagnosed with Type 2 Diabetes\* (only required of one partner)
  • Married or living with a romantic partner

Exclusion Criteria

  • Medical or physical contraindications to participate in physical activity

Outcomes

Primary Outcomes

Objective Physical Activity via accelerometer

Time Frame: Basline, 6 weeks

Participants will wear Actigraph Accelerometers

Self-Reported Physical Activity via IPAQ

Time Frame: Baseline, 3 weeks, 6 weeks

Participants will self-report their physical activity over the past week using the International Physical Activity Questionnaire (IPAQ)

Secondary Outcomes

  • Physical Activity Self-Efficacy via a self efficacy scale(Baseline, 3 weeks, 6 weeks)
  • Physical Activity Partner Investment Scale(Baseline, 3 weeks, 6 weeks)

Study Sites (1)

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