Plain English Summary
Background and study aims
Physical inactivity is a worldwide growing problem with one out of five adults not doing enough exercise. It is a risk factor for chronic diseases such as diabetes and cardiovascular diseases, being overweight and several cancers. Regular physical activity (PA) has a number of fitness and health related benefits and is associated with an estimated 30% reduction in risk for all-cause mortality (death) among adults. Regular, moderately intense exercise is important for a person’s physical and mental well-being, and the prevention and management of many chronic diseases. When people start doing PA, they often stop and become inactive again, even when they take part in PA programmes (or interventions). Many people become inactive again when intervention support is no longer provided. However, only sustained PA has an beneficial effect on health and the prevention of illness. It has been suggested that future PA interventions should include behavior maintenance strategies. These strategies should focus on what is most likely to keep people exercising. The barrier-belief approach concentrates on these proven behavior change strategies - change means reach goals, set (different) goals, restructure beliefs, induce acceptance. These are all applied to target the core of problems with starting and maintaining PA. Using well-known theories and strategies, the barrier-beliefs approach composes a way of counseling around the central construct of barrier-beliefs. The aim of this study is to assess how well a tailored BB counseling intervention performs compared with a group education program in general practice. A new perspective of changing behavior will be examined in primary care, called the BB Counseling Approach. The goal of the developing lifestyle intervention is to decrease medical complaints and care intake, to increase PA-behavior in subjects.
Who can participate?
Adults who consult their general practitioner, who are physically inactive.
What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 receive BB counseling intervention for a maximum of six months. Each participant decides himself how often they need an appointment with the counselor (with a maximum of 15 appointments during half a year). Those in group 2 receive a group education intervention. It encourages people to change their behavior by helping them to improve their knowledge about healthy behavior and achieve firm goals. All participants attend 5 group meetings and 2 one-to-one meetings. Those in group 3 are in the control group and do not receive an intervention.
What are the possible benefits and risks of participating?
The risk of injury or complications with this study is minimal. However, it is possible in any experiment that harmful effects may unexpectedly occur. Every precaution will be taken to prevent or minimize the occurrence of adverse events. These precautions include proper subject counselling, allowing only qualified counselors to support the process and administer all measurements. If injury does occur during counselling, the principal researcher will administer appropriate care and refer subjects for proper medical treatment.
Where is the study run from?
1. Institute of Sports Studies, Hanze University of Applied Sciences Groningen (Netherlands)
2. Social Psychology, Faculty of Behavioral and Society Sciences, University of Groningen (Netherlands)
3. Department of Sports Medicine and Orthopedic Surgery, University Medical Center Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
September 2010 to December 2015
Who is funding the study?
Institute of Sports Studies, Hanze University of Applied Sciences, Groningen (Netherlands)
Who is the main contact?
Dr Adrie Bouma
Trial website
Contact information
Type
Scientific
Primary contact
Dr Adrie Bouma
ORCID ID
http://orcid.org/0000-0002-5294-5044
Contact details
Institute of Sports Studies
Hanze University of Applied Sciences Groningen
Zernikeplein 17
Groningen
9747 AS
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of the barrier-belief counseling on physical activity in inactive adults.
Acronym
BB Counseling Approach (BBCA)
Study hypothesis
The barrier-belief counseling approach (BBCA) in the counseling of a physical activity (PA) in inactive adults is more effective than the usual care in primary health care setting.
Ethics approval
The Review Committee of the University Medical Centre in Groningen, The Netherlands 01/08/2010, ref: NL30895.042.10
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
"Not available in web format, please use contact details to request a patient information sheet
Condition
The PA-behavior of inactive adults in primary care will be studied.
Intervention
1. The intervention group
In PA counseling, barrier-beliefs (BBs) are addressed using four different BB behavior change strategies. The BB counseling aims to develop an individual pattern of PA for the long term that is adapted to the (often limited) motivation of the client, thereby preventing the occurrence of BBs. The client will learn to cope with factors that may inhibit PA in the future. This perspective of counseling barriers focuses mainly on exploring and resolving individual barriers experienced by subjects in the process of changing behavior and releasing guidelines to PA.
1.1. Channel: individual counseling sessions
1.2. Length: maximum 6 months and maximum 15 appointments.
Participants will be tested at 4 moments; T1: a pre-test before starting the intervention; T2: a post-test immediately after completing the intervention; T3: 6 months after T2; T4 6 months after T3.
2. Group education intervention (control group A)
The core of the group education intervention, or the “standard group intervention”, is a directive educational style for eliciting behavioral change by helping subjects to improve their knowledge about healthy behavior and achieve predetermined goals in which norms and guidelines will be leading.
2.1. Channel: group sessions;
2.2. Frequency: 7 moments of contact (5 group meetings and 2 individual meetings). Participants will be tested at 4 moments; T1: a pre-test before starting the intervention; T2: a post-test immediately after completing the intervention; T3: 6 months after T2; T4 6 months after T3.
3. Control group B
This group will receive no intervention, only a pre-test (T1) and 6 months later a post-test (T2).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. PA
2. Barrier-beliefs to PA
3. Medical complaints:
3.1. Perceived physical state of the subjects
3.2. Physical complaints
3.3. Psychological complaints
Secondary outcome measures
1. Diet
2. Body composition
3. Quality of life
4. Medical consumption
5. Psychological factors of health behavior
Overall trial start date
01/09/2010
Overall trial end date
30/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The patient has a demand for care in which a medical intervention or referral is not immediately indicated
2. In the opinion of the doctor, a behavioral change towards a healthier lifestyle can affect the decline for health care
3. Subject does not meet the ACSM-guidelines
4. Subject considers to change his behavior within six months
5. Subject voluntary commits to participate in the intervention and to finish it
6. Subject is aged between 18 - 70 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n=240 (80x intervention group; 80x control group a; 80x control group b)
Total final enrolment
281
Participant exclusion criteria
1. Subject has a disease or had recent a disease which unables participation (for instance: heart attack, recent operation, etc)
2. Subject suffers from depression longer than 6 months
3. Subject has chronic pain longer than 6 months
4. Subject is pregnant
5. Subject has difficulties with the Dutch language
6. There is co-morbidity
Recruitment start date
01/09/2010
Recruitment end date
01/09/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Institute of Sports Studies
Hanze University of Applied Sciences Groningen,
Zernikeplein 17
Groningen
9747 AS
Netherlands
Trial participating centre
Social Psychology, Faculty of Behavioral and Society Sciences
University of Groningen
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands
Trial participating centre
Department of Sports Medicine and Orthopedic Surgery
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor information
Organisation
University of Groningen
Sponsor details
Social Psychology
Faculty of Behavioral- and Society Sciences
Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands
Sponsor type
University/education
Website
Organisation
Department of Sports Medicine and Orthopedic Surgery
Sponsor details
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Institute of Sports Studies, Hanze University of Applied Sciences, Groningen (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
2018 thesis in https://www.rug.nl/research/portal/files/66611682/Complete_thesis.pdf
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30072044 (added 24/01/2020)