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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Region Örebro län

    Örebro, Örebro County, SE-70113

    Lars Hagberg, Ass prof, +46196027058, lars.hagberg@regionorebrolan.se

    Recruiting

Other trials in Sweden

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).

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 groups in NCT02938338
Study groupRoleWhat they receive
Obese patients with BMI above 35Bariatric surgery
Receives: Procedure: Bariatric surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calories consumed

    Amount calories consumed per day

    Measured: One year after surgery

  2. Hours sedentary

    Hours sedentary during a day

    Measured: One year after surgery

Secondary outcomes (1)
  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.

  1. First posted19 Oct 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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)
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

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.

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