An interventional study of CBT follow up in Obesity and Weight Loss, sponsored by Örebro County Council. Completed at 1 site in Sweden. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by Örebro County Council · Not applicable, Interventional, and Treatment
Among 178 studies in Obesity with a site in Sweden — 37 open to participants now, 48 under way, 8 of them phase 3. Obesity · Sweden.
Among the 178 studies in Obesity with a site in Sweden, this one is the 59th largest by enrollment of the 148 interventional ones that give a count, is one of 10 that started in 2012, is one of 87 with no phase, and was the 50th registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →37 of the 178 studies in Obesity with a site in Sweden are open now. Recruiting first, the newest first:
Karolinska Institutet · Sites in Sweden
Ages 18–64 · Women only
AstraZeneca · Sites in Sweden, United States, Argentina and 8 more countries
Ages 18+
Novo Nordisk A/S · Sites in Sweden, United States, Belgium and 7 more countries
Ages 18+
Novo Nordisk A/S · Sites in Sweden, United States, Greece and 3 more countries
Ages 18+
Eli Lilly and Company · Sites in Sweden, Germany
Ages 18–70 · Healthy volunteers
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
178 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 18 · Phase 3 27 · Phase 4 7
First in 1987; this study’s year is marked. 10 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 174 is above the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 110 across the 148 interventional studies, 103 across the 30 observational. Of the 109 that completed or were terminated, 12 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
45 of 178 have an industry lead sponsor. The 10 most frequent:
Örebro County Council is the lead sponsor of 22 studies on the registry; none are open to participants now.
Örebro County Council has 2 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
4 of the studies in Obesity with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07745504Phase 3Novo Nordisk A/SA Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight | 2027-05-18 |
| NCT07213245Göteborg UniversityMetabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF) | 2026-12-31 |
| NCT06151964AstraZenecaA Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight | 2027-01-29 |
| NCT07665879Eli Lilly and CompanyA Study of Eloralintide (LY3841136) in Participants With Overweight or Obesity | 2027-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 178 studies in Obesity with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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;
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ordinary follow up after 24 weeks of LCD diet + reintroduction of food.
11 weeks intervention programme with CBT conducted via internet.
Behavioral: CBT follow up
11 weeks programme conducted via internet. CBT with focus on weight stability.
• 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%
Time frame: Change from baseline to follow up at 1 and 2 years
• 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.
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
• 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.
Time frame: 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.
Time frame: baseline to 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2012 to primary completion in Jun 2017, 63 months.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 63 months is above that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Örebro County Council