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

NCT ID: NCT02579395

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

With spouse/romantic partner

Group Type: EXPERIMENTAL

Collaborative implementation Intentions

Intervention Type: BEHAVIORAL

With spouse/romantic partner

Without spouse/romantic partner

Group Type: EXPERIMENTAL

Individual implementation Intentions

Intervention Type: BEHAVIORAL

Without spouse/romantic partner

Control

No Intervention

Group Type: OTHER

Control

Intervention Type: BEHAVIORAL

Interventions

Collaborative implementation Intentions

With spouse/romantic partner

Intervention Type: BEHAVIORAL

Individual implementation Intentions

Without spouse/romantic partner

Intervention Type: BEHAVIORAL

Control

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennalee S Wooldridge, MA

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Denver, Colorado, United States

Countries

United States

Other Identifiers

15-0601

Identifier Type: -

Identifier Source: org_study_id