Sedentary LifestyleNCT02938338
Physical Activity, Sedentary and Energy Consumption After Bariatric Surgery
An observational study of Sedentary Lifestyle, run by Region Örebro County at 1 site in Sweden.
Trial summary
The aim is to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary. as input for the design of an intervention to reduce sedentary. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing bariatric surgery
Who may be able to join
- All patient at Lindesbergs hospital that get bariatric surgery (a limit to get the surgery is BMI above 35)
Who cannot join
- Not understanding Swedish or English
- Not the first bariatric surgery
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Region Örebro län
Örebro, Örebro County, SE-70113
Lars Hagberg, Ass prof, +46196027058, lars.hagberg@regionorebrolan.se
About this study
The aim is
to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary.
as input for the design of an intervention to reduce sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened.
Read the detailed description
The aim is
to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary.
as input for the design of an intervention to reduce sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened.
Hypothesis Patients who undergo bariatric surgery have before surgery low energy consumption related to physical activity. The investigators hypothesis is that low energy consumption for the most part retained and that is independent of whether one starts exercising or not.
About the level of physical activity and energy expenditure Increased physical activity after obesitasoperation is correlated with greater weight loss. According the Swedish Obesitas Surgery study, the percentage of persons who were classified as physically inactive decreased from 45% before surgery to less than 10% 6 months after surgery. The proportion of inactive people 6 years after surgery was 20%. Patients who undergo surgery for obesity has low energy consumption related to physical activity before surgery, as measured by pedometer or self-reported physical activity. The results in terms of increased physical activity after surgery are contradictory, where physical activity increases more in studies based on self-reported physical activity than in studies where measurements are made with the objective method. In a Swedish study (n = 56 women) no change could be seen in physical activity and sedentary after bariatric surgery. For a group of extremely obese (BMI around 50) were found reduced energy consumption by 25% after surgery. The decrease was related to lower body weight (average 53 kg) and thus decreased basal energy consumption and lower energy consumption during physical activity. A 20% decrease in body weight means an average of 400 kcal / day lower energy consumption.
Among adults is the basal energy consumption approximately 1,500 kcal per day (depending on body size). For adults, the average energy consumption related to physical activity 300 kcal / day, compared with 1000 kcal / day for people who traditionally live (hunter / gatherers). Patients who undergo bariatric surgery have weak mediating factors for physical activity.
About sedentary Sedentary and low energy consumption is a risk factor for cardiovascular disease, type 2 diabetes and premature death, even after correction for exercise / training and body mass index (BMI). Sedentary is also a contributing factor to obesity, independent of physical activity in general. Moving in everyday life (apart from exercise) is an essential part of the investigators energy consumption. The difference in energy consumption between a mainly sedentary person and a person who has a relatively moving life, may be 700 kcal per day) and compared with a very physically active (moving much at work and leisure), the difference be 2000 kcal per day. Among people with overweight or obesity, moving in everyday life is responsible for 90% of the energy consumption related to physical activity. Overweight people are sedentary 2-2.5 hours more per day than normal weight people, and that corresponding to a difference in energy of 350 kcal / day. In one year, that is equivalent to 15 kg of body weight. For the population as a whole, 60% of waking hours is sedentary.
About behavioral change and interventions to reduce sedentary For patients undergoing bariatric surgery are increased physical activity in everyday life / decreased sedentary very important for a positive weight development and favorable results regarding the health and quality of life, but low energy consumption in everyday life may remain after surgery.
It is difficult to change an established behavior, or a habit, well documented in social cognitive theory. Within this theoretical framework has also behavioral change models been developed. According to Nilsen et al is a habit behavior that has been repeated until it has become more or less automatically and is independently of the active awareness of what is happening. Gradually changing behavior control from being guided by beliefs, attitudes and intentions, that is triggered by a particular situation or context. It has been shown that behaviors that are repeated in a constant, unchanged context are difficult to change. So, change in the context where the habit has been established should to be important for a successful change of a habitual behavior.
Generally, there is lack of efficacy studies of interventions to reduce sedentary. A meta-analysis of interventions to reduce sedentary among adolescents show a small but significant effect. The focus in interventions and research should be on decreased sedentary connected to television and computer use, sitting at workplace and sitting in the car.
About mediating factors for increased physical activity and decreased sedentary Mediating factors for increased physical activity are factors that pave the way for change to come about and continue. The best evidence available for self-efficacy (situation-bound self-confidence, for example, "I know that I can take uo training again after a break."), social support (support and encouragement from family and friends) and enjoyment (experience / joy of movement).
- Conditions
- Sedentary Lifestyle
- Being tested
- Bariatric surgery
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery, with an anticipated mean weight loss of 30 kg
| Study group | Role | What they receive |
|---|---|---|
| Obese patients with BMI above 35 | Bariatric surgery Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories consumed
Amount calories consumed per day
Measured: One year after surgery
Hours sedentary
Hours sedentary during a day
Measured: One year after surgery
Secondary outcomes (1)
Mediators of physical activity
Self-efficacy, social support and enjoyment of physical activity measured by questionaires
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Hagberg, Region Örebro County
- Investigators
- Lars A Hagberg, PhD, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938338
- Sponsor's protocol ID
- Regionorebrolan 001
- Status last verified
- Oct 2016
- First submitted
- 28 Apr 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Sedentary and Energy Consumption After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02938338
- Acronym / sponsor ID
- Regionorebrolan 001
- Conditions
- Sedentary Lifestyle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- 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.
The aim is
to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary.
as input for the design of an intervention to reduce sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened.
Detailed description
The aim is
to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary.
as input for the design of an intervention to reduce sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened.
Hypothesis Patients who undergo bariatric surgery have before surgery low energy consumption related to physical activity. The investigators hypothesis is that low energy consumption for the most part retained and that is independent of whether one starts exercising or not.
About the level of physical activity and energy expenditure Increased physical activity after obesitasoperation is correlated with greater weight loss. According the Swedish Obesitas Surgery study, the percentage of persons who were classified as physically inactive decreased from 45% before surgery to less than 10% 6 months after surgery. The proportion of inactive people 6 years after surgery was 20%. Patients who undergo surgery for obesity has low energy consumption related to physical activity before surgery, as measured by pedometer or self-reported physical activity. The results in terms of increased physical activity after surgery are contradictory, where physical activity increases more in studies based on self-reported physical activity than in studies where measurements are made with the objective method. In a Swedish study (n = 56 women) no change could be seen in physical activity and sedentary after bariatric surgery. For a group of extremely obese (BMI around 50) were found reduced energy consumption by 25% after surgery. The decrease was related to lower body weight (average 53 kg) and thus decreased basal energy consumption and lower energy consumption during physical activity. A 20% decrease in body weight means an average of 400 kcal / day lower energy consumption.
Among adults is the basal energy consumption approximately 1,500 kcal per day (depending on body size). For adults, the average energy consumption related to physical activity 300 kcal / day, compared with 1000 kcal / day for people who traditionally live (hunter / gatherers). Patients who undergo bariatric surgery have weak mediating factors for physical activity.
About sedentary Sedentary and low energy consumption is a risk factor for cardiovascular disease, type 2 diabetes and premature death, even after correction for exercise / training and body mass index (BMI). Sedentary is also a contributing factor to obesity, independent of physical activity in general. Moving in everyday life (apart from exercise) is an essential part of the investigators energy consumption. The difference in energy consumption between a mainly sedentary person and a person who has a relatively moving life, may be 700 kcal per day) and compared with a very physically active (moving much at work and leisure), the difference be 2000 kcal per day. Among people with overweight or obesity, moving in everyday life is responsible for 90% of the energy consumption related to physical activity. Overweight people are sedentary 2-2.5 hours more per day than normal weight people, and that corresponding to a difference in energy of 350 kcal / day. In one year, that is equivalent to 15 kg of body weight. For the population as a whole, 60% of waking hours is sedentary.
About behavioral change and interventions to reduce sedentary For patients undergoing bariatric surgery are increased physical activity in everyday life / decreased sedentary very important for a positive weight development and favorable results regarding the health and quality of life, but low energy consumption in everyday life may remain after surgery.
It is difficult to change an established behavior, or a habit, well documented in social cognitive theory. Within this theoretical framework has also behavioral change models been developed. According to Nilsen et al is a habit behavior that has been repeated until it has become more or less automatically and is independently of the active awareness of what is happening. Gradually changing behavior control from being guided by beliefs, attitudes and intentions, that is triggered by a particular situation or context. It has been shown that behaviors that are repeated in a constant, unchanged context are difficult to change. So, change in the context where the habit has been established should to be important for a successful change of a habitual behavior.
Generally, there is lack of efficacy studies of interventions to reduce sedentary. A meta-analysis of interventions to reduce sedentary among adolescents show a small but significant effect. The focus in interventions and research should be on decreased sedentary connected to television and computer use, sitting at workplace and sitting in the car.
About mediating factors for increased physical activity and decreased sedentary Mediating factors for increased physical activity are factors that pave the way for change to come about and continue. The best evidence available for self-efficacy (situation-bound self-confidence, for example, "I know that I can take uo training again after a break."), social support (support and encouragement from family and friends) and enjoyment (experience / joy of movement).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients with BMI above 35 | – | Procedure: Bariatric surgeryBariatric surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing bariatric surgery
Key inclusion criteria (1 listed)
- All patient at Lindesbergs hospital that get bariatric surgery (a limit to get the surgery is BMI above 35)
Key exclusion criteria (2 listed)
- Not understanding Swedish or English
- Not the first bariatric surgery
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 |
|---|---|---|
| Bariatric surgeryBariatric surgery, with an anticipated mean weight loss of 30 kg | Procedure or surgery | Obese patients with BMI above 35 |
Primary outcome
Calories consumed
Time frame: One year after surgery
Amount calories consumed per day
Hours sedentary
Time frame: One year after surgery
Hours sedentary during a day
1 secondary outcome
Mediators of physical activity
Time frame: One year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Lars A Hagberg, PhD principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Lifestyle, run by Region Örebro County at 1 site in Sweden.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Oct 2016. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars A Hagberg, PhD (+46196027058, lars.hagberg@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories consumed (time frame: One year after surgery). The study lists 2 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 19 Oct 2016.