Clinical trial
Lifestyle Change: The Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07103005
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Intensive behavioral change with physical activity and diet. A single-group pre-post design
The group of 43 participants recieved a lifestyle intervention, and was measurred before and after the intervention. The intervention was intensive physical activity with focus om muscle strength and dietary advice from dietition, with focus on more fruits, vegetables, proteins and fiber. Body composition was measurred using Bioelectrical impedance, DEXA and WRIC. Health related quality of life was measured using the questionnaire RAND-36, and diet was registered with the questionnaire DIGIKOST.
Primary outcomes
Measurements of body composition i.e muscle mass was assessed by BIA
Measurements of body composition i.e muscle mass was also assessed by DEXA
REE was measured with indirect calorimetry
health related quality of life (HQoL) was assesed with RAND-36. RAND-36 has 36 questions with 8 dimentions. The scales are from 1-3 or 1-5. Low value estimates low scores.
Diet change was measured with a validated digital food frequency questionnaire (FFQ): Digikost. The DIGIKOST-FFQ assesses data on single food items as well as food groups according to the Norwegian FBDG and the data is presented in grams per day. DIGIKOST-FFQ also presents variables of different food groups according to the recommendations (Norwegian food-based dietary guidelines)
Study locations
1 locations were listed when this page was built. The first 40 are shown.