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

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.

Study Overview

• Status: Completed
• Conditions: Collaborative Implementation Intentions; Individual Implementation Intentions; Information Only Control Condition
• Intervention / Treatment: Behavioral: Control; Behavioral: Collaborative implementation Intentions; Behavioral: Individual implementation Intentions

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: With spouse/romantic partner	Behavioral: Collaborative implementation Intentions; With spouse/romantic partner
EXPERIMENTAL: Without spouse/romantic partner	Behavioral: Individual implementation Intentions; Without spouse/romantic partner
OTHER: Control; No Intervention	Behavioral: Control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jennalee S Wooldridge, MA, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (ESTIMATE): October 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 15-0601