The ABEL Feasibility Study (Adherence, Better Health, Exercise and Life Satisfaction)
NCT ID: NCT05792657
Last Updated: 2023-03-31
Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2023-01-26
2023-06-26
Brief Summary
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Detailed Description
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Obesity, defined as "abnormal or excessive fat accumulation that presents a risk to health" and a body mass index (BMI) of ≥30, represents a major health challenge and economic burden for welfare systems worldwide. Living with obesity is reported to account for 80-85% of the risk of developing non-communicable diseases such as diabetes type 2. Guidance on regular physical activity, exercise and healthy eating is traditionally the first measure taken for patient who undergo treatment for obesity. Treatment for obesity in the primary healthcare service is largely coordinated by general practitioners (GP). Green prescriptions (tailored advice and guidance on lifestyle factors related to development of disease, such as physical activity and healthy eating) can be prescribed as a treatment alternative to patients with chronic disease, such as obesity. However, few GPs in Norway use green prescriptions as a treatment alternative to their patients, and 41% of GPs in 2006 reported that they had newer prescribed green prescriptions to their patients. The lack of sufficient follow-up of patients has been reported as a main limitation with the current green prescription model.
Previous research underlines the importance in-person coaching for patients who receives green prescriptions, as well as establishing collaborations with professions such as exercise professionals to be able to provide sufficient coaching of patients. Hence, in-person coaching by an exercise professional may have the means to get more patients with obesity regularly active, and can potentially be the follow-up alternative the current green prescription model is lacking.
However, considering the expenses and practical considerations associated with in-person coaching, has former studies displayed the advantage of using web-based behavioral support for patients with obesity. Yet, web-based behavioral support often proves to have poor completion rate, and need to be combined with face-to-face guidance and feedback in order to increase adherence. However, when combining in-person coaching and web-based behavioral support, there is still limited knowledge on how frequent in-person coaching needs to occur, in order to increase adherence. More knowledge on frequency of follow-up is essential for an approach towards an economical sustainable green prescription model.
AIMS:
1. In women with obesity (BMI≥30), what is the effect of in-person exercise coaching (high vs. medium vs. low dosage) on exercise adherence and total physical activity level?
2. In women with obesity (BMI≥30), what is the effect of in-person exercise coaching (high vs. medium vs. low dosage) on mental health variables (quality of life, self-efficacy and barriers and motivation to exercise)?
3. In women with obesity (BMI≥30), what is the effect of in-person exercise coaching (high vs. medium vs. low dosage) on health (glycated hemoglobin, cholesterol, blood pressure, waist circumference, BMI and urinary incontinence) and physical fitness (aerobic endurance, muscular strength)?
4. Is adherence to exercise and succeeding health effects associated with the exercise professionals level of education and knowledge base?
5. What are the participant's experiences, barriers and facilitators of participating in the ABEL-project?
6. What are the general practitioners' experiences, barriers and facilitators of using the "green prescription"?
STUDY DESIGN AND METHOD:
In the present feasibility study, women with obesity (BMI of ≥30, n=200) will be recruited to a 20-week randomized control trial (RCT) with four arms. Participants will be recruited via social media platforms (Facebook and Instagram). Using simple computer-based randomization program, participants will be randomized to one of the following arms: HIGH dosage in person exercise coaching, MEDIUM dosage in-person exercise coaching, LOW dosage in-person exercise coaching, and CONTROL group. A total of 25 exercise professionals, working full time as a personal trainer will follow up the participants at one of the following fitness clubs: "Feel24", "PT-group", "Nr1 Fitness", "Trento" or "Spenst". All participants in the intervention arms (HIGH, MEDIUM and LOW) groups are provided the same frequency (each week) of follow-up by the exercise professional. At baseline, all participants will respond to an electronic questionnaire, perform measures of muscular strength and aerobic endurance, measure blood pressure, hip-waist ratio, BMI (height and weight) and take a blood sample (Tigeni Kit). After a 20-weeks intervention period, participants will perform a post-test including the same previous mentioned outcome measures.
n=15 of women from intervention arms HIGH (n=5), MEDIUM (n=5) and LOW (n=5), will also be invited to participate in an in-depth interview in order to investigate participants experiences and barriers for participating in the ABEL feasibility study.
In addition to the RCT, the project will also recruit GPs (n=8) to participate in an in-depth interview with researchers from the project group. GPs will be recruited to provide more in-depth understanding on reasons for what the current green prescription model is lacking.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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HIGH dosage in-person exercise coaching
One in-person exercise session with an exercise professional/weekly. A total of 20 hours of in-person coaching during the 20 weeks of intervention.
High dosage in-person exercise coaching
High dosage (one hour each week) of in-person exercise coaching by an exercise professional.
MEDIUM dosage in-person exercise coaching
Two in-person exercise session with an exercise professional/monthly, and 15 minutes web-based behavioral support on the non-supervised weeks.A total of 10 hours in-person coaching during the 20 weeks intervention.
Medium dosage in-person exercise coaching.
Medium dosage (one hour every other week) of in-person exercise coaching by an exercise professional.
LOW dosage in-person exercise coaching
One in-person exercise session with the exercise professional/monthly, and 15 minutes web-based behavioral support on the non-supervised weeks.Total of five hours of in-person coaching during the 20 weeks intervention.
Low dosage in-person exercise coaching
Low dosage (one hour every month) of in-person exercise coaching by an exercise professional
CONTROL
Will be asked to continuing with normal life, and will receive regular follow-up care from their GP. This group will be giving the "Norwegian Directorate of Health's" recommendations for physical activity and nutrition, and will have access to the ABEL-app in order to register physical activity and exercise, but will not be provided any coaching during the 20 weeks.
No interventions assigned to this group
Interventions
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High dosage in-person exercise coaching
High dosage (one hour each week) of in-person exercise coaching by an exercise professional.
Medium dosage in-person exercise coaching.
Medium dosage (one hour every other week) of in-person exercise coaching by an exercise professional.
Low dosage in-person exercise coaching
Low dosage (one hour every month) of in-person exercise coaching by an exercise professional
Eligibility Criteria
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Inclusion Criteria
* No fitness club membership six months prior to recruitment
* Low-active (\<150 minutes of moderate-intensity or 75 minutes of vigorous-intensity per week)
* Norwegian speaking
* In possession of a mobile phone.
Exclusion Criteria
* Changing GP during the intervention
* Functional impairment due to injuries hindering physical activity and exercise.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Kristiania University College
OTHER
ABEL Technologies
UNKNOWN
Norges idrettshøgskole
OTHER
Responsible Party
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Principal Investigators
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Tron Krosshaug, PhD
Role: STUDY_CHAIR
Norwegian School of Sport Sciences
Locations
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Norwegian School of Sport Sciences
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Tron Krosshaug, PhD
Role: primary
References
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O'Regan A, Pollock M, D'Sa S, Niranjan V. ABC of prescribing exercise as medicine: a narrative review of the experiences of general practitioners and patients. BMJ Open Sport Exerc Med. 2021 Jun 2;7(2):e001050. doi: 10.1136/bmjsem-2021-001050. eCollection 2021.
Elley CR, Garrett S, Rose SB, O'Dea D, Lawton BA, Moyes SA, Dowell AC. Cost-effectiveness of exercise on prescription with telephone support among women in general practice over 2 years. Br J Sports Med. 2011 Dec;45(15):1223-9. doi: 10.1136/bjsm.2010.072439. Epub 2010 Nov 16.
Ries AL, Kaplan RM, Myers R, Prewitt LM. Maintenance after pulmonary rehabilitation in chronic lung disease: a randomized trial. Am J Respir Crit Care Med. 2003 Mar 15;167(6):880-8. doi: 10.1164/rccm.200204-318OC. Epub 2002 Dec 27.
Powell-Wiley TM, Poirier P, Burke LE, Despres JP, Gordon-Larsen P, Lavie CJ, Lear SA, Ndumele CE, Neeland IJ, Sanders P, St-Onge MP; American Heart Association Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; and Stroke Council. Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 May 25;143(21):e984-e1010. doi: 10.1161/CIR.0000000000000973. Epub 2021 Apr 22.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Gjestvang C, Abrahamsen F, Stensrud T, Haakstad LAH. Motives and barriers to initiation and sustained exercise adherence in a fitness club setting-A one-year follow-up study. Scand J Med Sci Sports. 2020 Sep;30(9):1796-1805. doi: 10.1111/sms.13736. Epub 2020 Jun 15.
Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
McClaran SR. The effectiveness of personal training on changing attitudes towards physical activity. J Sports Sci Med. 2003 Mar 1;2(1):10-4. eCollection 2003 Mar.
Sorensen M, Gill DL. Perceived barriers to physical activity across Norwegian adult age groups, gender and stages of change. Scand J Med Sci Sports. 2008 Oct;18(5):651-63. doi: 10.1111/j.1600-0838.2007.00686.x. Epub 2007 Dec 11.
Murcia JA, Gimeno EC, Camacho AM. Measuring self-determination motivation in a physical fitness setting: validation of the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) in a Spanish sample. J Sports Med Phys Fitness. 2007 Sep;47(3):366-74.
Gron Jensen LC, Boie S, Axelsen S. International consultation on incontinence questionnaire - Urinary incontinence short form ICIQ-UI SF: Validation of its use in a Danish speaking population of municipal employees. PLoS One. 2022 Apr 6;17(4):e0266479. doi: 10.1371/journal.pone.0266479. eCollection 2022.
Moutao JM, Serra LF, Alves JA, Leitao JC, Vlachopoulos SP. Validation of the Basic Psychological Needs in Exercise Scale in a Portuguese sample. Span J Psychol. 2012 Mar;15(1):399-409. doi: 10.5209/rev_sjop.2012.v15.n1.37346.
Bringedal B, Aasland OG. [Doctors' use and assessment of a fee-for-service life-style advice scheme]. Tidsskr Nor Laegeforen. 2006 Apr 6;126(8):1036-8. Norwegian.
Brzycki M. Strength testing-predicting a one-rep max from reps-to-fatigue. Journal of Physical Education, Recreation & Dance. 1993;64(1):88-90.
Gjestvang C, Kalhovde JM, Mauseth Tangen E, Clemm H, Haakstad LAH. Impact of In-Person and Mobile Exercise Coaching on Psychosocial Factors Affecting Exercise Adherence in Inactive Women With Obesity: 20-Week Randomized Controlled Trial. J Med Internet Res. 2025 Feb 25;27:e68462. doi: 10.2196/68462.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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EMT2023
Identifier Type: -
Identifier Source: org_study_id