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

Study Overview
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Brief Summary
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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.

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

Conditions
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Collaborative Implementation Intentions, Individual Implementation Intentions, Information Only Control Condition

Intervention / Treatment
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* Behavioral: Collaborative implementation Intentions
* Behavioral: Individual implementation Intentions
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With spouse/romantic partner<br> | Behavioral: Collaborative implementation Intentions<br>* With spouse/romantic partner<br>|
| Experimental: Without spouse/romantic partner<br> | Behavioral: Individual implementation Intentions<br>* Without spouse/romantic partner<br>|
| Other: Control<br>No Intervention | Behavioral: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Physical Activity via IPAQ | Participants will self-report their physical activity over the past week using the International Physical Activity Questionnaire (IPAQ) | Baseline, 3 weeks, 6 weeks | 
| Objective Physical Activity via accelerometer | Participants will wear Actigraph Accelerometers | Basline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Self-Efficacy via a self efficacy scale | Physical activity self-efficacy will be measured using the self-efficacy for exercise scale (SEE; Resnick & Jenkins, 2000). This 9-item, self-report scale assesses participant's confidence that they could exercise three times per week for 20 minutes under various circumstances (e.g. you had to exercise alone; you felt tired). Respondents are asked to rate items on a scale from 1, (not at all confident), to 10 (extremely confident). | Baseline, 3 weeks, 6 weeks | 
| Physical Activity Partner Investment Scale | The Physical Activity Partner Investment Scale assesses the degree to which the partner in a couple defines the patient engaging in regular physical activity as a shared responsibility as well as the degree to which they are taking action to address barriers to the patient engaging in physical activity . The 9 items selected were modified to be specific to engaging in regular physical activity. Participants are asked to rate their agreement each item on a scale from 1 (strongly disagree) to 7 (strongly agree). Example items include If/when my partner decides to engage in regular physical activity , the responsibility will be his or hers alone., My partner and I are able to have useful discussions about how to engage in regular physical activity . and In the long run, my partner and I are able to work together toward helping one or both of us maintain a regular physical activity routine. | Baseline, 3 weeks, 6 weeks |