Clinical trial NCT05792657: The ABEL Feasibility Study (Adherence, Better Health, Exercise and Life Satisfaction)
Official title: The ABEL Feasibility Study (Adherence, Better Health, Exercise and Life Satisfaction): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Exercise is medicine
Exercise adherence
Total physical activity level
Exercise professionals
Women with obesity (>30 BMI)
Lead sponsor: Norges idrettshøgskole
Sponsor class: OTHER
Collaborators: name: Kristiania University College
name: ABEL Technologies
First posted: 2023-03-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Detailed description: BACKGROUND:

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adherence (attendance) to prescribed exercise sessions
timeFrame: Continuously during the intervention period of 20 weeks
Secondary outcomes:
measure: Fulfillment of physical activity recommendations
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Exercise frequency
timeFrame: At baseline and following the intervention (20 weeks).
measure: Duration of exercise sessions
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Mode of physical activity
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Health-related quality of life
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Self-efficacy
timeFrame: at baseline and following the intervention period (20 weeks)
measure: Motivation for exercise and physical activity
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Perceived social support from family and friends
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Stage of motivational readiness for exercise and physical activity
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Barriers to exercise
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Urinary incontinence
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Glycated hemoglobin
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Blood pressure
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Weight
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Height
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Cholesterol
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Heart rate recovery
timeFrame: At baseline and following the intervention period (20 weeks)
measure: The Borg Rating of Perceived Exertion (RPE)
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Working heart rate
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Muscular strength
timeFrame: At baseline and following the intervention period (20 weeks)
measure: Factors associated with exercise adherence and drop-out
timeFrame: Following the intervention period (20 weeks)
measure: Basic physicological needs in exercise (BPNES)
timeFrame: Following the intervention period (20 weeks)
measure: In-depth interview (general practitioners)
timeFrame: Following the intervention period (20 weeks)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: Norwegian School of Sport Sciences
name: Tron Krosshaug, PhD
role: STUDY_CHAIR
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