Physical Activity Clinical Trial
— DiMOfficial title:
Days in Motion: A Planning Intervention Study With Couples to Enhance Daily Physical Activity (DiM)
Verified date | January 2016 |
Source | Freie Universität Berlin |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Regular physical activity is one prominent health-protective behaviour which might increase
with the help of self-regulatory strategies such as action planning.
The aim of this randomised controlled trial is to examine changes in daily moderate physical
activity in couples following (a) a dyadic planning intervention, (b) an individual planning
intervention or (c) a no-planning control condition. Changes in daily physical activity will
be examined over a period of one year.
It is assumed that target persons from couples receiving a dyadic planning intervention will
show greater increases in daily physical activity than target persons from couples receiving
an individual planning intervention. For couples receiving a dyadic planning intervention or
an individual planning intervention, it is hypothesized that target persons will show higher
increases in daily physical activity than target persons from couples participating in the
no-planning control condition.
Status | Completed |
Enrollment | 346 |
Est. completion date | January 2016 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Married and/or cohabiting couples who are currently in a romantic relationship and have been living together for a minimum of 6 months Exclusion Criteria: - Being a minor (i.e., younger than 18 years) - Restrictions on being physically active as assessed by a risk-check form modelled after the Physical Activity Readiness Questionnaire - Being a competitive athlete and engaging in vigorous physical exercise for more than 3 hours per day - Participating in other intervention programmes targeting physical activity or weight-loss - Self-reported severe cardio-vascular or pulmonary disease, diseases or injury of the musculoskeletal system, degenerative neurological diseases, paraplegia - Pregnancy - A BMI below 17.5 - Insufficient comprehension of the German language |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Freie Universität Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Freie Universität Berlin | Deutsche Krebshilfe e.V., Bonn (Germany) |
Germany,
Bernstein M, Sloutskis D, Kumanyika S, Sparti A, Schutz Y, Morabia A. Data-based approach for developing a physical activity frequency questionnaire. Am J Epidemiol. 1998 Jan 15;147(2):147-54. Review. — View Citation
Burkert S, Scholz U, Gralla O, Roigas J, Knoll N. Dyadic planning of health-behavior change after prostatectomy: a randomized-controlled planning intervention. Soc Sci Med. 2011 Sep;73(5):783-92. doi: 10.1016/j.socscimed.2011.06.016. Epub 2011 Jul 12. — View Citation
Lewis MA, Rook KS. Social control in personal relationships: impact on health behaviors and psychological distress. Health Psychol. 1999 Jan;18(1):63-71. — View Citation
Mäder U, Martin BW, Schutz Y, Marti B. Validity of four short physical activity questionnaires in middle-aged persons. Med Sci Sports Exerc. 2006 Jul;38(7):1255-66. — View Citation
Scholz U, Sniehotta FF, Burkert S, Schwarzer R. Increasing physical exercise levels: age-specific benefits of planning. J Aging Health. 2007 Oct;19(5):851-66. — View Citation
Schulz, U., & Schwarzer, R. (2004). Long-term effects of spousal support on coping with cancer after surgery. Journal of Social and Clinical Psychology, 23, 716-732.
Sniehotta, F. F., Scholz, U., & Schwarzer, R. (2005). Bridging the intention-behaviour gap: Planning, selfefficacy, and action control in the adoption and maintenance of physical exercise. Psychology & Health, 20, 143-160.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical activity | Target persons' change in moderate daily physical activity (in minutes) from baseline (T0) until 6-weeks (T3) following the intervention will be assessed by an accelerometer device. At each assessment, accelerometer devices will be worn for 7 days. | six weeks post intervention | No |
Secondary | Cardiorespiratory fitness | Cardiorespiratory fitness in target persons and partners is measured by a 2-km walking test. Using the duration and heart-rate of the 2-km walking test, as well as age, sex and BMI, an index is calculated that represents the cardiorespiratory fitness measure which can be compared to norm values. | one year post intervention | No |
Secondary | Dyadic action planning | Dyadic action planning of daily physical activity will be assessed in target persons and partners by questionnaire. Couples' own regular dyadic action planning of target persons' and partners' daily physical activity during the past seven days will be assessed by four items using the stem "I have made a detailed plan together with my partner regarding ..." followed by (1) "when", (2) "where", (3) "how", and (4) "how often to be physically active" adapted from earlier research on dyadic planning of pelvic-floor training (Burkert et al., 2011). Response options range from 1 = "does not apply at all" to 6 = "applies exactly". |
one year post intervention | No |
Secondary | Individual action planning | Individual action planning of daily physical activity will be assessed in target persons and partners by questionnaire. Participants' own regular individual action planning of daily physical activities during the past seven days will be measured using four items using the stem "I have made a detailed plan regarding ..." followed by (1) "when", (2) "where", (3) "how", and (4) "how often to be physically active" (Scholz et al., 2007). Response options range from 1 = "does not apply at all" to 6 = "applies exactly". |
one year post intervention | No |
Secondary | Physical activity | Partners' daily physical activity will be objectively assessed in a parallel manner at the same four measurement occasions (T0, T2, T3, and T7). At each assessment, accelerometer devices will be worn for 7 days. Accelerometers will be worn by target persons and partners, providing data on activity counts, steps taken, activity intensity levels, and METs. | one year post intervention | No |
Secondary | Physical activity | Self-reported physical activity in target persons and partners is assessed by a combination of the Office in Motion questionnaire (OIMQ; Mäder et al., 2006) complemented by items of the Physical Activity Frequency Questionnaire (PAFQ; Bernstein, Sloutiskis, Kumanyika, Sparti, Schutz, & Morabia, 1998). This combined measure provides detailed information on time spent on physical activities of moderate and vigorous intensity within the past 7 days, covering the domains of transportation, occupational activity, household and yard work activities, and leisure-time physical activity. | one year post intervention | No |
Secondary | Individual action control | Physical activity-related individual action control during the past seven days will be assessed by 6 items addressing the three action control facets of comparative self-monitoring, awareness of standards, and self-regulatory effort (e.g., "During the last seven days I have really tried to be regularly physically active"; Sniehotta et al., 2005). Response options range from 1 = "does not apply at all" to 6 = "applies exactly". | one year post intervention | No |
Secondary | Received partner support | Physical activity-related received partner support during the past seven days will be assessed using 6 items from the Berlin Social Support Scales (Schulz & Schwarzer, 2004) adapted to the domain of physical activity (e.g., "My partner helped me to be physically active"). Response options range from 1 = "does not apply at all" to 6 = "applies exactly". | one year post intervention | No |
Secondary | Provided partner support | Physical activity-related provided partner support during the past seven days will be assessed using 6 items from the Berlin Social Support Scales (Schulz & Schwarzer, 2004) adapted to the domain of physical activity. These items will mirror the received support items (e.g., "I helped my partner to be physically active"). Response options range from 1 = "does not apply at all" to 6 = applies exactly". | one year post intervention | No |
Secondary | Received partner control | Physical activity-related received partner control during the past seven days will be assessed with a measure adapted from Lewis and Rook (1999). The scale consists of 8 items (e.g., "My partner pressured me to be physically active") measuring received partner control related to physical activity. Response options range from 1 = "does not apply at all" to 6 = "applies exactly". | one year post intervention | No |
Secondary | Provided partner control | Physical activity-related provided partner control during the past seven days will be assessed in accordance with Lewis and Rook (1999) by 8 items (e.g., "I pressured my partner to be physically active") applied to physical activity. Response options range from 1 = "does not apply at all" to 6 = "applies exactly". | one year post intervention | No |
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