Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741736
Status:
RECRUITING
Last Update Posted:
2023-02-23
First Post:
2023-02-04
Brief Title:
Five Days for Health FDH Small Group-based Lifestyle Modification Program on Weight Loss
Sponsor:
Clinical Hospital Centre Zagreb
Organization:
Clinical Hospital Centre Zagreb
Study Overview
Official Title:
Five Days for Health FDH Small Group-based Lifestyle Modification Program on Weight Loss
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:
FDH
Brief Summary:
Croatia is according to statistical data one of the countries in the European Union with the highest percentages of overweight and obese inhabitants Since the nature of obesity is multifactorial a multidisciplinary team should treat it in a comprehensive way A healthy lifestyle based on the promotion of a particular dietary pattern regular physical activity psychological support education and small group intervention results in weight loss We are aiming to develop a five-days small group-based lifestyle modification program on weight loss that would be appropriate in the general practice and outpatient setting facilities A structured 5-day lifestyle modification program led by endocrinologists-diabetologists together with a nutritionist a psychologist and a kinesiologist is aiming to educate on lifestyle modification necessary to lose weight
Detailed Description:
The program involves coherent groups of motivated participants in smaller groups of 7-10 persons Participants are adults with body mass index BMI in the range of overweight or obese and are motivated to change their lifestyle During the five days of the program held outside the medical facility positive interaction and mutual support of the participants develop in the group together with education and an informal approach along with practical workshops on nutrition daily physical activity and psychological support patients receive practical recommendations for life Follow-up continues in the form of short additional educational lectures support and body weight measurement after one month three months six months and after a year Participants are encouraged to stay in contact between the meetings using the same instant messaging platform in a form of a closed group and a leader of the program is sending inspirational messages and advice regularly Initially after 3 and 6 months a metabolic parameter evaluation is performed fasting glucose and insulin lipid profile as well as blood pressure is measured Individual anthropometric measurements of the participants are carried out on the first day of the program and continued at every visit The parameters taken are body height cm body mass kg waist circumference cm hip circumference cm BMI kgm2 the proportion of fat tissue and muscle tissue basal metabolism kcal and visceral adipose tissue On the first day of the program an initial questionnaire is filled out exploring sociodemographic and health data data on eating habits physical activity and psychological
Education During the 5-day participants have lectures explaining in a simple short interactive lecture a different topic related to obesity followed by discussion Topics explain concerns about obesity as a disease the background of obesity metabolic and cardiovascular consequences of obesity nonverbal communication and obesity the plateau phenomenon and the epidemiology of obesity
Nutrition The program helps participants to make healthier food choices by acquiring knowledge of nutrition basics and meal planning During the program the participants learn how to prepare easy and healthy meals for breakfast lunch dinner and snack read food labels and measure portion sizes with their hands
Physical activity Participants wear accelerometers before the beginning of the program During the program they are going to have daily 10 physical exercises exercise and explanations in a form of a complex of exercises designed for all adults especially for the working population The set of exercises consists of stretching and mobility exercises that are performed with light moderate movements and can be performed without hindrance in everyday work clothes They are going to be educated on how and how much to be physically active and how to choose the appropriate physical activity and activity intensity
Psychological support Daily support involves behavioural change that is working on goal setting and recognizing the advantages and disadvantages of changing behaviour Nex workshop works on recognizing the difference between emotional hunger and physical hunger identifying personal triggers and finding alternatives to emotional eating Participants identify the key distortions in the negative thoughts of dieters that prevent them from reaching and maintaining their desired weight and learn how to correct these distortions Also they learn what it means to have a positive or negative body image how body image affects mental and physical health and what we can do to improve our body image
Evaluation At the end of each lectureinteractive workshop participants fill out an evaluation questionnaire At the end of the education on the 5th day of education the participants fille out the final questionnaire outcome evaluation
Education During the 5-day participants have lectures explaining in a simple short interactive lecture a different topic related to obesity followed by discussion Topics explain concerns about obesity as a disease the background of obesity metabolic and cardiovascular consequences of obesity nonverbal communication and obesity the plateau phenomenon and the epidemiology of obesity
Nutrition The program helps participants to make healthier food choices by acquiring knowledge of nutrition basics and meal planning During the program the participants learn how to prepare easy and healthy meals for breakfast lunch dinner and snack read food labels and measure portion sizes with their hands
Physical activity Participants wear accelerometers before the beginning of the program During the program they are going to have daily 10 physical exercises exercise and explanations in a form of a complex of exercises designed for all adults especially for the working population The set of exercises consists of stretching and mobility exercises that are performed with light moderate movements and can be performed without hindrance in everyday work clothes They are going to be educated on how and how much to be physically active and how to choose the appropriate physical activity and activity intensity
Psychological support Daily support involves behavioural change that is working on goal setting and recognizing the advantages and disadvantages of changing behaviour Nex workshop works on recognizing the difference between emotional hunger and physical hunger identifying personal triggers and finding alternatives to emotional eating Participants identify the key distortions in the negative thoughts of dieters that prevent them from reaching and maintaining their desired weight and learn how to correct these distortions Also they learn what it means to have a positive or negative body image how body image affects mental and physical health and what we can do to improve our body image
Evaluation At the end of each lectureinteractive workshop participants fill out an evaluation questionnaire At the end of the education on the 5th day of education the participants fille out the final questionnaire outcome evaluation
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