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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02579395
Enrollment
80
Registered
2015-10-19
Start date
2015-10-31
Completion date
2018-02-28
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALCollaborative implementation Intentions

With spouse/romantic partner

BEHAVIORALIndividual implementation Intentions

Without spouse/romantic partner

BEHAVIORALControl

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective Physical Activity via accelerometerBasline, 6 weeksParticipants will wear Actigraph Accelerometers
Self-Reported Physical Activity via IPAQBaseline, 3 weeks, 6 weeksParticipants will self-report their physical activity over the past week using the International Physical Activity Questionnaire (IPAQ)

Secondary

MeasureTime frameDescription
Physical Activity Self-Efficacy via a self efficacy scaleBaseline, 3 weeks, 6 weeksPhysical 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).
Physical Activity Partner Investment ScaleBaseline, 3 weeks, 6 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026