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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Collaborative Implementation Intentions; Information Only Control Condition; Individual Implementation Intentions

Treatments: Behavioral: Collaborative implementation Intentions; Behavioral: Individual implementation Intentions; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02579395

15-0601

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

With spouse/romantic partner

Experimental group

Treatment:

Behavioral: Collaborative implementation Intentions

Without spouse/romantic partner

Experimental group

Treatment:

Behavioral: Individual implementation Intentions

Control

Other group

Description:

No Intervention

Treatment:

Behavioral: Control