Obesity and OverweightNCT07103005
Lifestyle Change: The Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life
A study testing Intensive behavioral change with physical activity and diet. A single-group pre-post design in people with Obesity and Overweight, run by VID Specialized University at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Intensive behavioral change with physical activity and diet. A single-group pre-post design
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 25 kg/m2
Who cannot join
- BMI< 25 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3-month Lifestyle Change Program's Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life
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.
Read more
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.
Read the detailed description
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.
In The Norwegian Healthy Life Centre Study by Samdal et al., the objective was to assess the impact of behavioral change interventions at Norwegian Healthy Life Centers on participants' physical activity six months after baseline. The study concluded that individuals with high socioeconomic status increased their physical activity more over the course of six months, but simultaneously consumed more unhealthy food. The intervention did not significantly influence dietary habits, but participants who attended the "good-food course" notably increased their consumption of healthy food. A follow-up study on HRQoL in 2020 revealed a positive association between physical activity and improved HRQoL. All HRQoL dimensions showed enhancement from baseline to the three-month follow-up, and these improvements were sustained at the 15-month follow-up.
By focusing on healthy lifestyle and weight reduction, valuable healthcare resources can be conserved, emphasizing the need for such programs outside specialized healthcare services. This also involves the individual's ability to cope and their overall quality of life. The study's findings can be leveraged to assess the influence of lifestyle programs and enhance the support available to adults with obesity.
The Kickstart program reveals a 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.
- Conditions
- Obesity and Overweight
- Being tested
- Intensive behavioral change with physical activity and diet. A single-group pre-post design
- Keywords
- Body composition, healthy diet
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive behavioral change with physical activity and diet. A single-group pre-post designProcedure or surgery
Also called Diet, Physical activity, social support
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.
| Study group | Role | What they receive |
|---|---|---|
| A Commercial intensiv intervention with physical activity and diet. A single-group pre-post design | Experimental | All participants recieved the lifestyle intervention. Camparisons were made before and after the intervention.
Body composition, Health realted quality of life and diet was registered before and after the intervention. Receives: Procedure: Intensive behavioral change with physical activity and diet. A single-group pre-post design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioelectircal impedance (BIA)
Measurements of body composition i.e muscle mass was assessed by BIA
Measured: Base line to three months, and one year follow up
Dual-Energy X-Ray Absorptiometry (DEXA).
Measurements of body composition i.e muscle mass was also assessed by DEXA
Measured: Base line to three months, and one year follow up
Resting energy expenditure (REE)
REE was measured with indirect calorimetry
Measured: Base line to three months, and one year follow up
Questionnaire RAND 36-Item Short Form Health Survey (RAND-36)
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.
Measured: Base line to three months, and one year follow up
Assessment of diet with Digikost questionnaire
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)
Measured: Base line to three months, and one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study has a single group pre-post design. The intervention is an intensiv lifestyle intervention with physical activity focusing on muscle strength, and diet change focusing on more fruits, vegetables, proteins and fiber. Measurements were done before and after the intervention. Methods that were used were Bioelectrical impedance to measure body composition, questionires as RAND-36 to meassure HQoL, and DIGIKOST to measure diet. We also registered muscle- and fat mass with Dual-energy Ray Absorptiometry (DEXA) and whole-room indirect calorimet (WRIC).
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- VID Specialized University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilde Trygstad, VID Specialized University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103005
- Sponsor's protocol ID
- 761798
- Other IDs
- Reference number: 193383
- Status last verified
- Jul 2025
- First submitted
- 23 May 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-month Lifestyle Change Program's Impact on Body Composition, Resting Metabolic Rate, Food Intake and Health-related Quality of Life
- ClinicalTrials.gov ID
- NCT07103005
- Acronym / sponsor ID
- 761798
- Conditions
- Obesity and Overweight
- Keywords
- Body composition, healthy diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- VID Specialized UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 Aug 2025 (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.
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.
Detailed description
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.
In The Norwegian Healthy Life Centre Study by Samdal et al., the objective was to assess the impact of behavioral change interventions at Norwegian Healthy Life Centers on participants' physical activity six months after baseline. The study concluded that individuals with high socioeconomic status increased their physical activity more over the course of six months, but simultaneously consumed more unhealthy food. The intervention did not significantly influence dietary habits, but participants who attended the "good-food course" notably increased their consumption of healthy food. A follow-up study on HRQoL in 2020 revealed a positive association between physical activity and improved HRQoL. All HRQoL dimensions showed enhancement from baseline to the three-month follow-up, and these improvements were sustained at the 15-month follow-up.
By focusing on healthy lifestyle and weight reduction, valuable healthcare resources can be conserved, emphasizing the need for such programs outside specialized healthcare services. This also involves the individual's ability to cope and their overall quality of life. The study's findings can be leveraged to assess the influence of lifestyle programs and enhance the support available to adults with obesity.
The Kickstart program reveals a 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study has a single group pre-post design. The intervention is an intensiv lifestyle intervention with physical activity focusing on muscle strength, and diet change focusing on more fruits, vegetables, proteins and fiber. Measurements were done before and after the intervention. Methods that were used were Bioelectrical impedance to measure body composition, questionires as RAND-36 to meassure HQoL, and DIGIKOST to measure diet. We also registered muscle- and fat mass with Dual-energy Ray Absorptiometry (DEXA) and whole-room indirect calorimet (WRIC).
| Arm | Type | Receives |
|---|---|---|
| A Commercial intensiv intervention with physical activity and diet. A single-group pre-post design | Experimental | Procedure: Intensive behavioral change with physical activity and diet. A single-group pre-post designAll participants recieved the lifestyle intervention. Camparisons were made before and after the intervention. Body composition, Health realted quality of life and diet was registered before and after the intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > 25 kg/m2
Key exclusion criteria (1 listed)
- BMI< 25 kg/m2
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 |
|---|---|---|
| Intensive behavioral change with physical activity and diet. A single-group pre-post designAlso: Diet, Physical activity, social supportThe 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. | Procedure or surgery | A Commercial intensiv intervention with physical activity and diet. A single-group pre-post design |
Primary outcome
Bioelectircal impedance (BIA)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive behavioral change with physical activity and diet. A single-group pre-post design in people with Obesity and Overweight, run by VID Specialized University at 1 site in Norway.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioelectircal impedance (BIA) (time frame: Base line to three months, and one year follow up). The study lists 5 primary outcomes in all. 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 5 Aug 2025.