ObesityFDHNCT05741736
Five Days for Health (FDH): Small Group-based Lifestyle Modification Program on Weight Loss
A study testing five-days small group-based lifestyle modification program in people with Obesity and Overweight, run by Clinical Hospital Centre Zagreb at 2 sites in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- five-days small group-based lifestyle modification program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCroatia
- Study dates
- 23 Jan 2023to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants between the ages of 18 and 70
- body mass index (BMI kg/m2) between 25-45
- able to travel regularly to the study location
- interested in participating in a weight loss program.
Who cannot join
- currently enrolled in another organized weight loss program
- taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
- history of gastric bypass or other surgical weight loss procedures
- medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
- pregnancy or planning to become pregnant during the next two years -
- breastfeeding
- consuming an amount of alcohol that could interfere with study completion
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites, 2 recruiting
- Recruiting
Croatian Institute of Public Health
Zagreb, 10 000
Dora Bukal, ++385 1 48 63 212, savjetovalista@hzjz.hr
Slaven Krtalić
- Recruiting
Universtiy Hospital Centre Zagreb
Zagreb, 10 000
Maja Baretić, ++385 1 23 88 888, maja.baretic@kbc-zagreb.hr
Martina Matovinović
About this study
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.
Read the 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 (kg/m2), 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 lecture/interactive 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).
- Conditions
- Obesity, Overweight
- Being tested
- five-days small group-based lifestyle modification program
- Keywords
- obesity, overweight, lifestyle modification, weight loss, small group program, multidisciplinary team
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
five-days small group-based lifestyle modification programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Group | Other | 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. Receives: Behavioral: five-days small group-based lifestyle modification program |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
difference between basal weight and after 12 months
Measured: 12 months
Secondary outcomes (2)
body composition
difference between basal fat percentage and after 12 months
Measured: 12 months
metabolic parameters
difference between basal fasting glucose and lipid profila and after 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start23 Jan 2023
- Primary completion23 Dec 2024 (estimated)
- Study completion23 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Institute of Public Health
- Responsible party
- Principal investigator, Maja Baretić, Clinical Hospital Centre Zagreb
- Investigators
- Maja Baretić, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741736
- Sponsor's protocol ID
- 02/013-JG
- Acronym
- FDH
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Days for Health (FDH): Small Group-based Lifestyle Modification Program on Weight Loss
- ClinicalTrials.gov ID
- NCT05741736
- Acronym / sponsor ID
- FDH / 02/013-JG
- Conditions
- Obesity, Overweight
- Keywords
- obesity, overweight, lifestyle modification, weight loss, small group program, multidisciplinary team
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Collaborators
- Croatian Institute of Public Health
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 23 Dec 2024 (estimated)
- Study completion
- 23 Dec 2024 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (kg/m2), 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 lecture/interactive 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | Other | Behavioral: five-days small group-based lifestyle modification programA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants between the ages of 18 and 70
- body mass index (BMI kg/m2) between 25-45
- able to travel regularly to the study location
- interested in participating in a weight loss program.
Key exclusion criteria (7 listed)
- currently enrolled in another organized weight loss program
- taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
- history of gastric bypass or other surgical weight loss procedures
- medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
- pregnancy or planning to become pregnant during the next two years -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| five-days small group-based lifestyle modification programhealthy lifestyle, based on the promotion of a particular dietary pattern, regular physical activity, psychological support, education, and small group intervention results in weight loss | Behavioural | Group |
Primary outcome
weight loss
Time frame: 12 months
difference between basal weight and after 12 months
2 secondary outcomes
body composition
Time frame: 12 months
metabolic parameters
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No. on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maja Baretić principal investigator
Clinical Hospital Centre Zagreb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing five-days small group-based lifestyle modification program in people with Obesity and Overweight, run by Clinical Hospital Centre Zagreb at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maja Baretić (++385 98 412284, maja.baretic@kbc-zagreb.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.