Clinical trial NCT02579395: A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes
Official title: A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Collaborative Implementation Intentions
Individual Implementation Intentions
Information Only Control Condition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Self-Reported Physical Activity via IPAQ
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Objective Physical Activity via accelerometer
timeFrame: Basline, 6 weeks
Secondary outcomes:
measure: Physical Activity Self-Efficacy via a self efficacy scale
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Physical Activity Partner Investment Scale
timeFrame: Baseline, 3 weeks, 6 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennalee S Wooldridge, MA
role: PRINCIPAL_INVESTIGATOR
References: