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NCT07103005Active, not recruiting

Lifestyle Change: The Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life

A 3-month Lifestyle Change Program's Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life

Source: ClinicalTrials.gov · Last updated 5 Aug 2025

Brief summary (registry, in English)

In Norway, a significant proportion of the adult population is currently classified as overweight (\~50%) or obese (\~23%). Over the past four decades, there has been a significant rise in the prevalence of overweight and obesity in both children and adults. Obesity is associated with a higher risk of chronic diseases such as cardiovascular diseases, type 2 diabetes, respiratory disease, osteoarthritis and specific cancers. Consequently, leading to increased morbidity and reduction in life expectancy. A healthy lifestyle including meeting recommendations for diet and physical activity is considered beneficial the prevention of chronic diseases, and for quality of life. There is limited evidence on weight reduction programs implemented outside specialized healthcare services, however intensive lifestyle modifications have demonstrated promising effects on sustainable weight loss. The Kickstart Program is a lifestyle program addressing weight reduction, changes in body composition and improved health-related quality of life (HRQoL) by integrating personalized dietary guidance and physical activity (PA) over a three, four or six-month period for registered participants, and can be considered an organized follow-up intervention. The participants receive close monitoring and support from clinical dietitians, physiotherapists and personal trainers. Unlike patients in specialized healthcare, Kickstart participants sign up and pay for it themselves, without any support from referrals or financial aid. This financial commitment is thought to make participants more motivated and facilitate compliance with the program. Recognizing the potential of programs like Kickstart to reduce healthcare costs by preventing lifestyle diseases, especially outside of specialized healthcare, shows why it is important to study how well they work. The study's findings can be leveraged to assess the influence of lifestyle programs and enhance the support available to adults with obesity. The study will tighten the knowledge gap concerning how an intervention of intensive dietary changes and PA specifically effects weight loss, FFM and HRQoL within a three-month timeframe. The overall aim of the study is to investigate the effect of a combined diet and PA intervention for people with a BMI\>25 kg/m² on body weight, body composition, RMR and HRQoL.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
43 (actual)
First submitted
23 May 2025
Start date
1 Aug 2024
Primary completion date
31 Dec 2026
Lead sponsor
VID Specialized University
Diseases
Obesity
NCT number
NCT07103005

What you commit to

  • Study type: Interventional
  • Participants enrolled: 43
  • From 1 Aug 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • BMI\< 25 kg/m2

Who the study is looking for

  • BMI \> 25 kg/m2

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VID Specialized University
Coordinator of this site? Confirm its status
OsloNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.