The ABEL Feasibility Study (Adherence, Better Health, Exercise and Life Satisfaction)

NCT05792657 | Unknown

• 1 other identifier: EMT2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The ambition of the ABEL feasibility study is to test new "green prescription" follow-up models that can get more women with obesity, regularly active, with improved health and physical fitness. The project will evaluate the effect on exercise behavior, total physical activity level and mental and physical health outcomes by four different follow-up models by an exercise professional: HIGH-dosage in-person exercise coaching (four session monthly), MEDIUM- dosage in-person exercise coaching (two sessions monthly) LOW-dosage in-person exercise coaching (one session monthly). The main aim of this study is to evaluate which of these follow-up models is most effective on improving women's exercise adherence, total physical activity level, physical fitness, and mental and physical health. This will be weighed against the cost of each of the follow-up models, in order to identify the best model from a socioeconomic cost-effectiveness perspective. Moreover, the study will identify potential barriers among patients, General Practitioners and exercise professionals that prevents optimal outcome from the current green prescription model.

Conditions

Obesity

Keywords

Exercise is medicine; Exercise adherence; Total physical activity level; Exercise professionals; Women with obesity (>30 BMI)

Outcome Measures

Primary Outcomes (1)

• Adherence (attendance) to prescribed exercise sessions

  Measures of adherence to exercise sessions will be collected through the ABEL-app (ABEL Technologies). Sessions performed with the exercise professional will be logged through the ABEL-app of the exercise professional, while sessions performed independently will be logged through the ABEL-app of the participant. Participants adherence will be measured by attendance (percentage of exercise sessions completed out of exercise sessions offered).

  Continuously during the intervention period of 20 weeks

Secondary Outcomes (23)

• Fulfillment of physical activity recommendations

  At baseline and following the intervention period (20 weeks)

• Exercise frequency

  At baseline and following the intervention (20 weeks).

• Duration of exercise sessions

  At baseline and following the intervention period (20 weeks)

• Mode of physical activity

  At baseline and following the intervention period (20 weeks)

• Health-related quality of life

  At baseline and following the intervention period (20 weeks)

Study Arms (4)

HIGH dosage in-person exercise coaching

EXPERIMENTAL

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.

Behavioral: High dosage in-person exercise coaching

MEDIUM dosage in-person exercise coaching

EXPERIMENTAL

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.

Behavioral: Medium dosage in-person exercise coaching.

LOW dosage in-person exercise coaching

EXPERIMENTAL

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.

Behavioral: Low dosage in-person exercise coaching

CONTROL

NO INTERVENTION

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.

Interventions

High dosage in-person exercise coaching BEHAVIORAL

High dosage (one hour each week) of in-person exercise coaching by an exercise professional.

HIGH dosage in-person exercise coaching

Medium dosage in-person exercise coaching. BEHAVIORAL

Medium dosage (one hour every other week) of in-person exercise coaching by an exercise professional.

MEDIUM dosage in-person exercise coaching

Low dosage in-person exercise coaching BEHAVIORAL

Low dosage (one hour every month) of in-person exercise coaching by an exercise professional

LOW dosage in-person exercise coaching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 65 years
• 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.

You may not qualify if:

• Chronic disease or pathology (e.g severe hypertension 180/110 mm Hg), heart disease or lung disease hindering exercise
• Changing GP during the intervention
• Functional impairment due to injuries hindering physical activity and exercise.

Sponsors & Collaborators

• Norges idrettshøgskole: lead
• Kristiania University College: collaborator
• ABEL Technologies: collaborator

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0806, Norway

RECRUITING

Related Publications (15)

• 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.

  PMID: 34150320 BACKGROUND

• 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.

  PMID: 21081641 BACKGROUND

• 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.

  PMID: 12505859 BACKGROUND

• 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.

  PMID: 33882682 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 32488898 BACKGROUND

• 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.

  PMID: 3432232 BACKGROUND

• 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.

  PMID: 24616604 BACKGROUND

• 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.

  PMID: 18086263 BACKGROUND

• 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.

  PMID: 17641607 BACKGROUND

• 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.

  PMID: 35385519 BACKGROUND

• 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.

  PMID: 22379729 BACKGROUND

• 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.

  PMID: 16619061 BACKGROUND

• Brzycki M. Strength testing-predicting a one-rep max from reps-to-fatigue. Journal of Physical Education, Recreation & Dance. 1993;64(1):88-90.

  BACKGROUND

• 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.

  PMID: 39999434 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tron Krosshaug, PhD

  Norwegian School of Sport Sciences

  STUDY CHAIR

Central Study Contacts

Tron Krosshaug, PhD

CONTACT

+4745660046; Tronk@nih.no

Elene M Tangen, Msc

CONTACT

+4795787210; Elene.tangen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Each participant will be randomly assigned (1:1:1:1) to one intervention group, HIGH, MEDIUM, LOW or CONTROL following a simple computer-based randomization program. All participants included in the study will conduct the baseline assessments before the randomization procedure. The study design will not allow for further masking of study participants or the exercise professional (caregivers to the interventions). Those from the research group involved in inclusion of the participants or follow-up measurements will not have access to the group allocation list. Further, all measurements will be completed and plotted without the research group information of group allocation. The statistical analyses will be done in SPSS, following a predefined analysis plan and before unmasking the study arms.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 31, 2023
• Study Start: January 26, 2023
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-02

Locations

NO (1)