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OpenTrials
Completed

NCT Number: NCT02579395

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.

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Key information

Conditions

Collaborative Implementation Intentions Individual Implementation Intentions Information Only Control Condition

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative implementation Intentions

Behavioral

With spouse/romantic partner

Individual implementation Intentions

Behavioral

Without spouse/romantic partner

Control

Behavioral

Primary outcomes

  1. Self-Reported Physical Activity via IPAQ

    Time frame: Baseline, 3 weeks, 6 weeks

    Participants will self-report their physical activity over the past week using the International Physical Activity Questionnaire (IPAQ)

  2. Objective Physical Activity via accelerometer

    Time frame: Basline, 6 weeks

    Participants will wear Actigraph Accelerometers

Secondary outcomes

  1. Physical Activity Self-Efficacy via a self efficacy scale

    Time frame: Baseline, 3 weeks, 6 weeks

    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).

  2. Physical Activity Partner Investment Scale

    Time frame: Baseline, 3 weeks, 6 weeks

    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".

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 19, 2015
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.