ObesityLCD-KBTNCT01608191
Obesity Treatment With LCD in Primary Health Care
A study testing CBT follow up in people with Obesity and Weight Loss, run by Örebro County Council at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy) programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can reduce weight gain and improve weight stability, self reported health, pain, eating behavior, fatigue and mood. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- CBT follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Jun 2017
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 30 with health problems and willingness and motivation to make lifestyle changes.
- Access to the internet and the ability to read and understand written information in swedish.
Who cannot join
- BMI < 30
- Excessive eating disorder problems (screening forms are used)
- Severe heart failure (New York Heart Association (NYHA) class III-IV)
- Moderate or severe COPD (Chronic Obstructive Pulmonary Disease) (FEV% <50)
- Uncontrolled asthma (hospitalization or more than twice requiring inhalation treatment on health care site last year)
- Pregnancy and lactation
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- Type 1 Diabetes
- Serious liver dysfunction (ALT value more than doubled, women> 1.5 μkat / L, men> 2.2 μkat / L)
- Former Gastric bypass surgery or other weight reducing surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity Treatment With LCD(Low Calorie Diet) in Primary Health Care - Long Term Effects With or Without Internet Based CBT (Cognitive Behavioral Therapy) , for Weight Stability
The aim of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy) programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can reduce weight gain and improve weight stability, self reported health, pain, eating behavior, fatigue and mood.
Adults with obesity and health problems in primary health care are invited to be part of the study. The geographical area is Orebro county which has in all 29 primary health care centers. Population is 276 000, and according to population studies around 15% of the adult population has a BodyMassIndex (BMI) over 30, which is characterized as obesity according to WHO.
Read more
Specific objectives are;
- To evaluate if internet-based CBT treatment after LCD improves weight stability after 1 and 2 years.
- To evaluate if weight loss improves metabolic parameters such as HbA1c, blood glucose, Cholesterol, Low density lipoproteins (LDL),High density lipoproteins (HDL) , triglycerides (TG) and Bloodpressure (BP)
- To evaluate weight loss influence on quality of life, body pain, eating behavior, obesity related problems, fatigue and mood, and to see if CBT program for weight stability also improves these factors
- To evaluate if LCD treatment is a possible treatment for obesity in ordinary primary health care
Patients taking part in the study, undergo a 12 week period of Low Calorie Diet (LCD) treatment, followed by a 12 week reintroduction to ordinary food. During this period the patient has contact with the primary health care nurse and doctor. After 24 weeks of treatment, the patient who follows the study is supposed to have lost around 10% of initial weight.All patients losing more than 7% weight during the first 24 weeks, are randomized to either ordinary follow up (group 1) or an internet-based CBT programme for weight stability (group 2). All patients in the study are followed at 1 year by doctor, and at 2 year by nurse visit.
Read the detailed description
Patients are recruited in an ordinary primary care setting in Primary care centers in Orebro County. All Primary care centers in the area (26) are invited to take part in the study.
Patients are given brief information at ordinary visits at doctor, nurse or physiotherapists, or by written information announced at the health care center. Before going into the study they need a doctors visit to pass the inclusion and exclusion criteria. The study starts at a nurse visit where the patient gets written information about the LCD treatment and the protocol.
After 24 weeks in the study, all patients with weight loss of 7% or more are randomized into two groups.
Group 1, keep their contact with the nurse at the primary health care centre, and gets a written prescription of physical activity, which is followed by a visit at 36 weeks.
Group 2, gets a code for the internet-based CBT programme. They go into the programme at home, and follow the programme which has the goal of weight stability and contains strategies of meal plans, portion controls, physical activity planning, and cognitive strategies of thinking and goal setting. During this programme there is an opportunity to "chat" with CBT therapists via the internet, concerning the programme and its challenges. No personal meeting with therapist is included.
At 1 year in the study both groups meed with doctor at primary health care center and at 2 year there is a nurse follow up at the same center.
At baseline, 12 weeks, 24 weeks, 1 year and 2 years several validated instruments are used to follow patients wellbeing due to:
- Quality of life (Short Form -36, SF-36)
- Obesity related problems (Obesity related Problems Scale version 3 OPv3)
- Mood (Mood Adjective Chek List MACL)
- Self reported pain (Brief Pain Inventory Short form BPI-SF)
- Eating behavior (Three Factor Eating Questionnaire- Revised 21 Items TFEQ-R21)
- Fatigue (Multidimensional Fatigue Inventory MFI)
We also investigate the patients experiences of the treatment, how they manage to hold on to the diet, and how it effects their motivation for ongoing lifestyle changes. For this we use a study specific instrument.
- Conditions
- Obesity, Weight Loss
- Being tested
- CBT follow up
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT follow upBehavioural
11 weeks programme conducted via internet. CBT with focus on weight stability.
| Study group | Role | What they receive |
|---|---|---|
| Ordinary primary care follow up | No intervention | Ordinary follow up after 24 weeks of LCD diet + reintroduction of food. |
| CBT follow up | Active comparator | 11 weeks intervention programme with CBT conducted via internet. Receives: Behavioral: CBT follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Weight reduction in kg and % from baseline to 1 and 2 years
Patients in the intervention group (Group 2) have an average of 5 kg greater weight loss at 1 year follow-up compared with patients in the control group (Group 1) Out of patients completing 1 year of treatment, 75% reached the weight loss -5%, and 50% have achieved weight loss - 10%
Measured: Change from baseline to follow up at 1 and 2 years
Secondary outcomes (3)
• LCD treatment is an effective and suitable treatment for primary health care
We use a questionnaire that states the patients view about the treatment, and also measurement of how many patients are lost to follow up, or do not go through the full treatment.
Measured: Change from baseline to follow up at 1 and 2 years
Improved metabolic control (lower weight and waist circumference, lower TGA) Higher HDL, lower Hba1c
- Patients , regardless of treatment group, has improved metabolic control (higher HDL, lower TGA, lower weight and waist circumference) compared to baseline measurements at 1 year. Lower fasting plasma glucose (fP-glucose) and HbA1C in subgroup type 2 diabetics at 1 year compared to baseline.
Measured: From baseline to 1 year
Quality of life improvements in both groups compared with baseline at one year
- Quality of life and Obesity problems measured by SF36 and OPv3 improves with weight loss. Self reported pain (BPI-SF), eating behavior (TFEQ-R21), mood (MACL)and fatigue (MFI) also improves with weightloss in both groups.
We also want to compare the two groups in order to see if the CBT programme has additional effects on these parameters.
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jan Karlsson, Örebro County Council
- Investigators
- Jan Karlsson, Principal investigator, Universitetssjukvårdens forskningscentrum, UFC, Region Örebro län, Box 1613, 70116 Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608191
- Sponsor's protocol ID
- OCC-LCD-PV
- Other IDs
- 2011/434
- Acronym
- LCD-KBT
- Status last verified
- Sep 2018
- First submitted
- 25 May 2012
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Treatment With LCD(Low Calorie Diet) in Primary Health Care - Long Term Effects With or Without Internet Based CBT (Cognitive Behavioral Therapy) , for Weight Stability
- ClinicalTrials.gov ID
- NCT01608191
- Acronym / sponsor ID
- LCD-KBT / OCC-LCD-PV
- Conditions
- Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Study start
- Mar 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 May 2012 (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 of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy) programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can reduce weight gain and improve weight stability, self reported health, pain, eating behavior, fatigue and mood.
Adults with obesity and health problems in primary health care are invited to be part of the study. The geographical area is Orebro county which has in all 29 primary health care centers. Population is 276 000, and according to population studies around 15% of the adult population has a BodyMassIndex (BMI) over 30, which is characterized as obesity according to WHO.
Specific objectives are;
- To evaluate if internet-based CBT treatment after LCD improves weight stability after 1 and 2 years.
- To evaluate if weight loss improves metabolic parameters such as HbA1c, blood glucose, Cholesterol, Low density lipoproteins (LDL),High density lipoproteins (HDL) , triglycerides (TG) and Bloodpressure (BP)
- To evaluate weight loss influence on quality of life, body pain, eating behavior, obesity related problems, fatigue and mood, and to see if CBT program for weight stability also improves these factors
- To evaluate if LCD treatment is a possible treatment for obesity in ordinary primary health care
Patients taking part in the study, undergo a 12 week period of Low Calorie Diet (LCD) treatment, followed by a 12 week reintroduction to ordinary food. During this period the patient has contact with the primary health care nurse and doctor. After 24 weeks of treatment, the patient who follows the study is supposed to have lost around 10% of initial weight.All patients losing more than 7% weight during the first 24 weeks, are randomized to either ordinary follow up (group 1) or an internet-based CBT programme for weight stability (group 2). All patients in the study are followed at 1 year by doctor, and at 2 year by nurse visit.
Detailed description
Patients are recruited in an ordinary primary care setting in Primary care centers in Orebro County. All Primary care centers in the area (26) are invited to take part in the study.
Patients are given brief information at ordinary visits at doctor, nurse or physiotherapists, or by written information announced at the health care center. Before going into the study they need a doctors visit to pass the inclusion and exclusion criteria. The study starts at a nurse visit where the patient gets written information about the LCD treatment and the protocol.
After 24 weeks in the study, all patients with weight loss of 7% or more are randomized into two groups.
Group 1, keep their contact with the nurse at the primary health care centre, and gets a written prescription of physical activity, which is followed by a visit at 36 weeks.
Group 2, gets a code for the internet-based CBT programme. They go into the programme at home, and follow the programme which has the goal of weight stability and contains strategies of meal plans, portion controls, physical activity planning, and cognitive strategies of thinking and goal setting. During this programme there is an opportunity to "chat" with CBT therapists via the internet, concerning the programme and its challenges. No personal meeting with therapist is included.
At 1 year in the study both groups meed with doctor at primary health care center and at 2 year there is a nurse follow up at the same center.
At baseline, 12 weeks, 24 weeks, 1 year and 2 years several validated instruments are used to follow patients wellbeing due to:
- Quality of life (Short Form -36, SF-36)
- Obesity related problems (Obesity related Problems Scale version 3 OPv3)
- Mood (Mood Adjective Chek List MACL)
- Self reported pain (Brief Pain Inventory Short form BPI-SF)
- Eating behavior (Three Factor Eating Questionnaire- Revised 21 Items TFEQ-R21)
- Fatigue (Multidimensional Fatigue Inventory MFI)
We also investigate the patients experiences of the treatment, how they manage to hold on to the diet, and how it effects their motivation for ongoing lifestyle changes. For this we use a study specific instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ordinary primary care follow up | No intervention | –Ordinary follow up after 24 weeks of LCD diet + reintroduction of food. |
| CBT follow up | Active comparator | Behavioral: CBT follow up11 weeks intervention programme with CBT conducted via internet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 30 with health problems and willingness and motivation to make lifestyle changes.
- Access to the internet and the ability to read and understand written information in swedish.
Key exclusion criteria (9 listed)
- BMI < 30
- Excessive eating disorder problems (screening forms are used)
- Severe heart failure (New York Heart Association (NYHA) class III-IV)
- Moderate or severe COPD (Chronic Obstructive Pulmonary Disease) (FEV% <50)
- Uncontrolled asthma (hospitalization or more than twice requiring inhalation treatment on health care site last year)
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 |
|---|---|---|
| CBT follow up11 weeks programme conducted via internet. CBT with focus on weight stability. | Behavioural | CBT follow up |
Primary outcome
• Weight reduction in kg and % from baseline to 1 and 2 years
Time frame: Change from baseline to follow up at 1 and 2 years
Patients in the intervention group (Group 2) have an average of 5 kg greater weight loss at 1 year follow-up compared with patients in the control group (Group 1) Out of patients completing 1 year of treatment, 75% reached the weight loss -5%, and 50% have achieved weight loss - 10%
3 secondary outcomes
• LCD treatment is an effective and suitable treatment for primary health care
Time frame: Change from baseline to follow up at 1 and 2 years
Improved metabolic control (lower weight and waist circumference, lower TGA) Higher HDL, lower Hba1c
Time frame: From baseline to 1 year
Quality of life improvements in both groups compared with baseline at one year
Time frame: baseline to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- 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.
Jan Karlsson principal investigator
Universitetssjukvårdens forskningscentrum, UFC, Region Örebro län, Box 1613, 70116 Örebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT follow up in people with Obesity and Weight Loss, run by Örebro County Council 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 17 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
• Weight reduction in kg and % from baseline to 1 and 2 years (time frame: Change from baseline to follow up at 1 and 2 years). 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 17 Sep 2018.