Active Choice Intervention About Physical Activity for Physically Inactive Adults

Physical Activity Clinical Trial

Official title:

Effects of an Active Choice Intervention on Physical Activity Intentions and Behaviour Among Physically Inactive Adults: A Four-Arm Web-Based Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973813
• Other study ID #: 2020.142
• Status: Completed
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 9, 2020

Study information

• Verified date: July 2021
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This web-based experimental study aims to ascertain whether promoting an active (i.e. conscious and autonomous) choice process about physical activity results in better behavioural outcomes (e.g. physical activity) and psychological outcomes (e.g. physical activity intention) compared to promoting a passive choice process in physically inactive adults.

Description:

In this web-based experimental study, the investigators will use a pre-test post-test four-arm parallel design to compare the effect of promoting an active choice process versus a passive choice process about physical activity on behavioural outcomes (e.g. physical activity behaviour, perceived increase in physical activity) and psychological outcomes (e.g. physical activity intention, commitment) among physically inactive adults.

Participants will be randomized to one of four groups. Participants in group GA+ will be encouraged to make a very active choice by weighing advantages and disadvantages of physical activity, considering personal values, identifying barriers and engaging in action and coping planning. The intervention for group GA is similar, but lacks the action and coping planning exercises. In the other two groups, a passive choice process will be promoted by only providing information: Group G will read the national physical activity guideline and group GI will read the guideline and information about possible advantages and disadvantages and barriers to physical activity. Behavioural and psychological outcomes will be assessed at the first measurement and follow-up measurement. Regression analyses will be performed to examine intergroup differences. In addition, sensitivity analyses and a process evaluation will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: October 9, 2020
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Low levels of physical activity (i.e. physically active for at least 30 minutes on <5 days a week and engaging in <150 minutes of physical activity in total throughout an average week)

Exclusion Criteria:

• Pregnancy

• Wheelchair user

• Not being able to walk a minimum of 100 meters

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Guideline + Active Choice + action&coping planning (GA+)
Web-based intervention consisting of information and assignments, including: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; action planning; identifying barriers to physical activity; coping planning
• Guideline + Active Choice (GA)
Web-based intervention consisting of information and several assignments, including: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; identifying barriers to physical activity.
• Guideline + information (GI)
Web-based information about the national physical activity guideline, pros and cons of physical activity, and possible barriers to physical activity.
• Guideline (G)
Web-based information about the national physical activity guideline.

Locations

Country	Name	City	State
Netherlands	VUMedicalCenter	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention	Intention to become more physically active (yes/no), assessed by a questionnaire	Directly after the intervention (Day 0)
Primary	Physical activity	Physical activity levels (MET minutes per week), assessed by the short form of the International Physical Activity Questionnaire (IPAQ)	Change from baseline at approximately 18 days
Secondary	Sitting time	Sitting time (minutes per day), assessed by the short form of the International Physical Activity Questionnaire (IPAQ)	Change from baseline at approximately 18 days
Secondary	Perceived change in physical activity compared to baseline	Questionnaire item: Participants' self-perceived change in physical between baseline and follow-up. Dichotomous outcome (change/no change).	Change from baseline at approximately 18 days
Secondary	Intention strength	Questionnaire item: scale 0 (no strong intention) - 10 (very strong intention). a higher score indicates higher intention strength.	Change from day 0, at approximately 18 days
Secondary	Active choice	Degree to which an active choice is made; a composite score of 9 items on a scale of 1 (totally not agree) - 5 (totally agree); a higher score indicates a more active choice.	Directly after the intervention (Day 0)
Secondary	Autonomous choice	Degree to which an autonomous choice is made; 2 items on a scale of 1 - 10. For the first item, a higher score indicates a more autonomous choice, whereas for the second item, a higher score indicates a less autonomous choice.	Directly after the intervention (Day 0)
Secondary	Commitment	Commitment to become more physically active; 1 item on a scale of 0 (no commitment) - 10 (high commitment). A higher score indicates higher commitment.	Directly after the intervention (Day 0)
Secondary	Commitment	Commitment to become more physically active; 1 item on a scale of 0 (no commitment) - 10 (high commitment). A higher score indicates higher commitment.	Change from day 0, at approximately 18 days follow-up
Secondary	Self-efficacy	Self-efficacy to become more physically active; 2 items on a scale of 1 (no self-efficacy) - 10 (high self-efficacy). A higher score indicates more self-efficacy.	Directly after the intervention (Day 0)
Secondary	Self-efficacy	Self-efficacy to become more physically active; 2 items on a scale of 1 (no self-efficacy) - 10 (high self-efficacy). A higher score indicates more self-efficacy.	Change from day 0, at approximately 18 days follow-up
Secondary	Satisfaction about one's plan	Degree of satisfaction with one's plan to become or not become more physically active on a scale of 1 (no satisfaction) to 10 (high satisfaction).	Directly after the intervention (Day 0)
Secondary	Alignment of choice with personal values	Extent to which one's plan to become/ not become more physically active corresponds with what one considers important; 1 item on a scale of 1 (no alignment) - 10 (high alignment)	Directly after the intervention (Day 0)
Secondary	Perceived advantages and disadvantages of physical activity	Open-ended questions about the perceived advantages and disadvantages of one's current physical activity behavior, and of increasing physical activity.	During intervention (Day 0)
Secondary	Value of health	Importance of the value 'health', on a scale of 1 (not important at all) to 10 (very important), and the time, effort and energy spent on health on a scale of 1 (no time, effort and energy) to 10 (very much time, effort and energy)	During intervention (Day 0)
Secondary	Values influencing physical activity	The extent to which the following values impact one's physical activity levels on a scale of 1 (no influence) to 10 (high influence): responsibility, achievement, pleasure, family, friendships, balance.	During intervention (Day 0)
Secondary	Plans to change physical activity	Open-ended questions about the preferred kind of physical activity, frequency, location, days and start date.	During intervention (Day 0)
Secondary	Perceived barriers to physical activity	Open-ended question asking about perceived barriers to physical activity	During intervention (Day 0)
Secondary	Plans to cope with perceived barriers	Open-ended questions about the ways one could cope with each perceived barriers	During intervention (Day 0)
Secondary	Factors supporting physical activity	Question about the factors that supported or would support physical activity. Multiple choice question.	Follow-up; approximately 18 days after the intervention (day 0)
Secondary	Barriers to physical activity	Question about the barriers that hindered physical activity in the past two weeks. Multiple choice question.	Follow-up; approximately 18 days after the intervention (day 0)