NCT05741736

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

February 4, 2023

Last Update Submit

February 14, 2023

Conditions

ObesityOverweight

Keywords

obesityoverweightlifestyle modificationweight losssmall group programmultidisciplinary team

Outcome Measures

Primary Outcomes (1)

  • weight loss

    difference between basal weight and after 12 months

    12 months

Secondary Outcomes (2)

  • body composition

    12 months

  • metabolic parameters

    12 months

Study Arms (1)

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.

Behavioral: five-days small group-based lifestyle modification program

Interventions

five-days small group-based lifestyle modification programBEHAVIORAL

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

Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Croatian Institute of Public Health

Zagreb, 10 000, Croatia

RECRUITING

Universtiy Hospital Centre Zagreb

Zagreb, 10 000, Croatia

RECRUITING

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Maja Baretić

    Clinical Hospital Centre Zagreb

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Baretić

CONTACT

++385 98 412284maja.baretic@kbc-zagreb.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialis of internal medicine, consultant endocriologist and diabetologist, assistant professor

Study Record Dates

First Submitted

February 4, 2023

First Posted

February 23, 2023

Study Start

January 23, 2023

Primary Completion

December 23, 2024

Study Completion

December 23, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

on request

Locations

CR(2)