Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792657
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-02-10
Brief Title:
The ABEL Feasibility Study Adherence Better Health Exercise and Life Satisfaction
Sponsor:
Norges idrettshøgskole
Organization:
Norges idrettshøgskole
Study Overview
Official Title:
The ABEL Feasibility Study Adherence Better Health Exercise and Life Satisfaction A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 BMI30 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 BMI30 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 BMI30 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 participants 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 n200 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
n15 of women from intervention arms HIGH n5 MEDIUM n5 and LOW n5 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 n8 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
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 BMI30 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 BMI30 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 BMI30 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 participants 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 n200 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
n15 of women from intervention arms HIGH n5 MEDIUM n5 and LOW n5 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 n8 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None