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临床试验/NCT07103005
NCT07103005进行中(未招募)不适用

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

VID Specialized University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
43
试验地点
2
主要终点
Bioelectircal impedance (BIA)

研究概览

简要总结

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.

详细描述

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.

Earlier studies have focused on the effect on body weight og body mass index (BMI). Because of the limitations with BMI, it is also important to study body composition. Body composition refers to the proportion of fat, muscle, bone, and other tissues that make up a person's body weight. It provides information about the distribution and relative proportions of body tissues, which can be important for evaluating overall health status, and progression of fitness during and after lifestyle change. Measurements of body composition can include body fat percentage (%), visceral fat, and fat free mass (FFM), including muscle mass that is the primary variable of interest in this study.

Resting metabolic rate (RMR) is the energy the body uses at rest to maintain vital functions. RMR is the main contributor to total energy expenditure, contributing up to 60-70 %. Other components of total energy expenditure is energy used from physical activity (20-30%) and lastly from the thermic effect of food (10%). Studies have demonstrated a decrease in RMR following weight loss, largely attributed to the loss of FFM, which plays a significant role in metabolic rate. It has been speculated that rapid weight loss induce metabolic adaptations resulting in greater than predicted decreases in RMR.

The concept of HRQoL is frequently utilized to assess how health status influences overall quality of life. Reported low HRQoL is typically found in individuals with multiple chronic conditions and low levels of PA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 25 kg/m2

排除标准

  • BMI< 25 kg/m2

结局指标

主要结局

Bioelectircal impedance (BIA)

时间窗: Base line to three months, and one year follow up

Measurements of body composition i.e muscle mass was assessed by BIA

Dual-Energy X-Ray Absorptiometry (DEXA).

时间窗: Base line to three months, and one year follow up

Measurements of body composition i.e muscle mass was also assessed by DEXA

Resting energy expenditure (REE)

时间窗: Base line to three months, and one year follow up

REE was measured with indirect calorimetry

Questionnaire RAND 36-Item Short Form Health Survey (RAND-36)

时间窗: Base line to three months, and one year follow up

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.

Assessment of diet with Digikost questionnaire

时间窗: Base line to three months, and one year follow up

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)

次要结局

未报告次要终点

研究者

发起方
VID Specialized University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilde Trygstad

Section Leader

VID Specialized University

研究点 (2)

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