ObesityNCT04230655
Weight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon
A study testing Low energy diet using meal replacements, CBT-based group treatment and Intragastric balloon in people with Obesity and Weight Loss, run by Region Örebro County at 1 site in Sweden.
Trial summary
In Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life (QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver disease (NAFLD), cancer and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obesity, Weight Loss, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Low energy diet using meal replacements, CBT-based group treatment and Intragastric balloon
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 10 Dec 2019to Dec 2022
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30 and ≤45 kg/m^2
- Age 30 to 65 years
Who cannot join
- Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months
- Daily use of meal replacement products within the last 3 months
- Previous gastric surgery
- Current gastric, duodenal or oesophageal ulcers
- Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease
- Known potential upper gastrointestinal bleeding conditions such as gastric or oesophageal varices
Show all 27Show fewer
- Known structural abnormalities of the pharynx or oesophagus
- Symptoms suggestive for severe gastric motility disorder
- Known hiatus hernia ≥ 5 cm
- Cancer diagnosed within the last 5 years or ongoing treatment for cancer (except non-metastasising skin cancer)
- Known severe heart failure (NYHA 3-4)
- Known chronic obstructive pulmonary disease (FEV1 ≤ 50 percent)
- Kidney failure (eGFR ≤ 30 ml/min)
- Liver failure (liver enzymes more than 3 times the normal threshold)
- Known proliferative retinopathy
- Known or suspected abuse of alcohol or narcotics
- Current or history of systemic treatment with corticosteroids within the last 3 months
- Known myocardial infarction or stroke within the last 6 months
- Current or history of pancreatitis
- Pregnancy, intention to become pregnant or breastfeeding during the study
- Untreated or insufficient treated hypo- or hyperthyroidism
- Current use of anticoagulants: warfarin, apixaban, dabigatran, edoxaban and rivaroxaban
- Current use of thrombocyte aggregation inhibitors: clopidogrel and acetylsalicylic acid
- Known or previous eating disorder
- Antimicrobial treatment within 3 months prior to study may lead to postponed participation
- Regular consumption of probiotic capsules within 1 month prior to study start may lead to postponed participation
- Participants considered to be unsuitable for the study by the investigator (e.g. serious psychiatric disorders, suspected eating disorders)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Medicinmottagning 5/Överviktsenheten, University Hospital Örebro
Örebro, 70185
Marije Galavazi, PhD, MD, +46196026631, marije.galavazi@regionorebrolan.se
Kristina Sigvardsson, Study nurse, +46196026635, kristina.sigvardsson@regionorebrolan.se
About this study
Official title: The Effects of a Low Energy Diet Versus Low Energy Diet and Intragastric Balloon in Adults With Obesity, All in Combination With Group Treatment: a Randomized, Controlled Trial
In Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life (QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver disease (NAFLD), cancer and cardiovascular diseases. Consequently, weight loss improves QoL and decreases the risk for obesity-related comorbidities.
A treatment combination using a low energy diet (LED) and group treatment based on cognitive behavioral therapy (CBT), leads to 18 percent weight loss after 6 months. Six months treatment with an intragastric balloon (IGB) leads to 13 percent weight loss. However, both treatments are usually followed by weight regain. Combining these treatments has not been studied before but could lead to better weight maintenance.
Read more
The hypothesis is that treatment of adults with obesity, with LED, CBT and IGB, leads to greater weight loss after 1 year compared to treatment with LED and CBT only.
The study is a randomized, controlled clinical trial, with a 2-year follow-up. One hundred and ten adults, age 30-65 years, with a BMI of 30-45 kg/m^2 will be included. All participants will receive 6 months of LED, followed by randomization to either 6 months with IGB or a control group without IGB. All participants receive CBT-based group treatment during 12 months and followed up after 2 years.
If the treatment combination of LED, CBT and IGB leads to significant weight loss and improved weight maintenance, increased QoL and reductions of comorbidities and costs of health care are expected. Effects of treatment on eating behavior, NAFLD, physical activity, psychological parameters, the gut microbiota, gut permeability and metabolomics will be assessed.
- Conditions
- Obesity, Weight Loss, Non-Alcoholic Fatty Liver Disease
- Being tested
- Low energy diet using meal replacements, CBT-based group treatment, Intragastric balloon
- Keywords
- Obesity, Weight loss, Low energy diet, Intragastric balloon, Group treatment, Non-alcoholic fatty liver disease, Quality of life, Body weight, Glucose metabolism, Eating behavior, Microbiomics, Physical activity, Gastrointestinal symptoms, Psychological parameters
- Medical subject headings
- Obesity, Weight Loss, Non-alcoholic Fatty Liver Disease, Body Weight, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy diet using meal replacementsDietary supplement
Also called LED
The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended.
CBT-based group treatmentBehavioural
Also called CBT
All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants.
Intragastric balloonDevice
Also called IGB
An IGB (Orbera IGB, Apollo Endosurgery Inc., Austin, Texas, (CE certified)) is set in place endoscopically by a gastroenterologist at Örebro University Hospital, Region Örebro county, and is left in the stomach for 6 months. A proton-pump inhibitor is prescribed to counteract an increased risk to develop a gastric ulcer. During the first 2 weeks, dietary adjustments are necessary to adapt to the IGB. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended identical to the control group. The IGB is removed endoscopically after 6 months IGB treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | All participants in the control group are treated with LED and CBT-based group treatment as described below.
All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants. Two groups of about the same size start simultaneously.
The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended. Receives: Dietary Supplement: Low energy diet using meal replacements; Behavioral: CBT-based group treatment |
| IGB group | Experimental | All participants in the IGB group are treated with LED and CBT-based group treatment as described for the control group.
Participants in the intervention group are treated with an IGB for 6 months from 6 months from start. Receives: Dietary Supplement: Low energy diet using meal replacements; Behavioral: CBT-based group treatment; Device: Intragastric balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss in percent of total body weight
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Measured: Change from baseline at 12 months
Secondary outcomes (27)
Weight loss in percent of total body weight
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Measured: Change from baseline at 6 months
Weight loss in percent of total body weight at 2-year follow-up
Two years after treatment start and thus one year after completion of the intervention, participants will be followed up on total body weight. Weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Measured: Change from baseline at 24 months
The proportion of participants with ≥5 percent reduction of total body weight from baseline
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Measured: 6, 12 and 24 months
The proportion of participants with ≥10 percent reduction of total body weight from baseline
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Measured: 6, 12 and 24 months
The proportion of participants with ≥15 percent reduction of total body weight from baseline
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Measured: 6, 12 and 24 months
Effect of treatment on bioelectrical impedance measurement to assess fat mass
Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Fatt mass is estimated and results are presented in kilograms.
Measured: Change from baseline at 6, 12 and 24 months
Effect of treatment on bioelectrical impedance measurement to assess muscle mass
Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Muscle mass is estimated and results are presented in kilograms.
Measured: Change from baseline at 6, 12 and 24 months
Change in waist circumference
Waist circumference is measured in centimeters according to the World Health Organization protocol.
Measured: Change from baseline at 6, 12 and 24 months
Change in 2-hour oral glucose tolerance test
Effect on the 2-hour oral glucose tolerance test (OGTT) is measured by analysing glucose (mmol/L) in a fasting blood sample. Thereafter the participant drinks a standardized amount of glucose. After 120 minutes, a blood sample is analyzed again for glucose (mmol/L) .
Measured: Change from baseline at 6 and 12 months
Change in Hemoglobin A1c
Hemoglobin A1c (HbA1c) in mmol/L is analyzed in a fasting blood sample.
Measured: Change from baseline at 6 and 12 months
Change in serum lipids
Total cholesterol, HDL, LDL and triglycerides are analyzed in a fasting blood sample. Results are presented in mmol/L.
Measured: Change from baseline at 6 and 12 months
Change in insulin
Insulin is analyzed in a fasting blood sample and presented in mIE/L.
Measured: Change from baseline at 6 and 12 months
Change in Homeostatic Model Assessment of Insulin Resistance
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is calculated using fasting values of insulin and glucose.
Measured: Change from baseline at 6 and 12 months
Change in kidney function
Kidney function is assessed by analysing blood samples for creatinine (µmol/L). The result is used to calculate the estimated glomerular filtration rate (eGFR) using the Lund-Malmö revised calculation. eGFR is presented as mL/min/1,73m^2.
Measured: Change from baseline at 6 and 12 months
Change in liver transaminases
Liver transaminases are measured by analysing alanine transaminase (ALT) and aspartate transaminase (AST) in a fasting blood sample. Data is presented in µkat/L.
Measured: Change from baseline at 6 and 12 months
Change in thrombocytes
Thrombocytes are analyzed in a fasting blood sample and presented as 10*9/L.
Measured: Change from baseline at 6 and 12 months
Change in blood pressure
Blood pressure is measured using a correct cuff size for the circumference of participant's arm after 5 minutes rest in a sitting position.
Measured: Change from baseline at 6 and 12 months
Effect of treatment on vibration-controlled transient elastography measurement to assess level of liver steatosis and fibrosis
Evaluation of NAFLD at baseline and effect of treatment using vibration-controlled transient elastography to detect liver stiffness (in kPa) and determine the steatosis and fibrosis score (0 to 4 there 0 means no steatosis or fibrosis).
Measured: Change from baseline at 6 and 12 months
Effect of treatment on RAND-36 (SF-36) to measure QoL
RAND-36 (SF-36) questionnaire is validated to measure QoL and comprises 36 items measuring eight domains that reflect a wide spectrum of physical and mental health aspects: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Measured: Change from baseline at 6, 12 and 24 months
Effect of treatment on the Obesity-related Problems scale, version 3 (OPv3) to measure weight-related psychosocial functioning
OPv3 is validated to measure obesity-specific quality of life with 26 items. OP measures the negative effects of obesity on psychosocial functioning.
Measured: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Effects of treatment on the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18V2) items to measure eating behavior
The TFEQ-R18V2 is a validated questionnaire to measure three aspects of eating behavior: uncontrolled eating (9 items), cognitive restraint (3 items), and emotional eating (6 items).
Measured: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Effects of treatment on hunger and satiety
Hunger and satiety are assessed by a questionnaire with 9 single items on a 5-point Likert scale.
Measured: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Effect of treatment on 7-day step count to measure physical activity
Step count is measured during 7 consecutive days using an accelerometer. The data is completed with questions on water-based activities and cycling on these days.
Measured: Change from baseline at 6, 12 and 24 months
Effect of treatment on sitting time and physical activity
Self-reported data on physical activity will be measured by a validated questionnaire from the National Board of Health and Welfare, Sweden, concerning sitting time and hours of light and moderate activity.
Measured: Change from baseline at 6, 12 and 24 months
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia is assessed by asking participants at every study contact, if changes in medication have been made. A patient record survey for prescribed medication is performed at 12 and 24 months.
Measured: Change from baseline at 6, 12 and 24 months
The effect of treatment on the use of health care and absence from work during treatment
Health care utilization and absence from work are measured with self-assessment questionnaires. A patient record survey is performed at 12 and 24 months.
Measured: Change from baseline at 6, 12 and 24 months
Calculation of cost-effectiveness of treatment using multi-variable analysis
Cost-effectiveness is analyzed using data on health care utilization, absence from work, use of medication and QoL questionnaires (RAND-36 and OPv3). Data is combined and analyzed together to calculate and report cost-effectiveness. All used measurements are also described above as separate secondary outcome measures.
Measured: Change from baseline at 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 Dec 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Model description
- The study design is an open labelled, randomized, controlled clinical trial, with a ratio 1:1.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Jendle, Professor, Principal investigator, johan.jendle@oru.se
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230655
- Sponsor's protocol ID
- 256841
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Low Energy Diet Versus Low Energy Diet and Intragastric Balloon in Adults With Obesity, All in Combination With Group Treatment: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04230655
- Acronym / sponsor ID
- 256841
- Conditions
- Obesity, Weight Loss, Non-Alcoholic Fatty Liver Disease
- Keywords
- Obesity, Weight loss, Low energy diet, Intragastric balloon, Group treatment, Non-alcoholic fatty liver disease, Quality of life, Body weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Jan 2020 (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 Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life (QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver disease (NAFLD), cancer and cardiovascular diseases. Consequently, weight loss improves QoL and decreases the risk for obesity-related comorbidities.
A treatment combination using a low energy diet (LED) and group treatment based on cognitive behavioral therapy (CBT), leads to 18 percent weight loss after 6 months. Six months treatment with an intragastric balloon (IGB) leads to 13 percent weight loss. However, both treatments are usually followed by weight regain. Combining these treatments has not been studied before but could lead to better weight maintenance.
The hypothesis is that treatment of adults with obesity, with LED, CBT and IGB, leads to greater weight loss after 1 year compared to treatment with LED and CBT only.
The study is a randomized, controlled clinical trial, with a 2-year follow-up. One hundred and ten adults, age 30-65 years, with a BMI of 30-45 kg/m^2 will be included. All participants will receive 6 months of LED, followed by randomization to either 6 months with IGB or a control group without IGB. All participants receive CBT-based group treatment during 12 months and followed up after 2 years.
If the treatment combination of LED, CBT and IGB leads to significant weight loss and improved weight maintenance, increased QoL and reductions of comorbidities and costs of health care are expected. Effects of treatment on eating behavior, NAFLD, physical activity, psychological parameters, the gut microbiota, gut permeability and metabolomics will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is an open labelled, randomized, controlled clinical trial, with a ratio 1:1.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Dietary Supplement: Low energy diet using meal replacements, Behavioral: CBT-based group treatmentAll participants in the control group are treated with LED and CBT-based group treatment as described below. All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants. Two groups of about the same size start simultaneously. The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended. |
| IGB group | Experimental | Dietary Supplement: Low energy diet using meal replacements, Behavioral: CBT-based group treatment, Device: Intragastric balloonAll participants in the IGB group are treated with LED and CBT-based group treatment as described for the control group. Participants in the intervention group are treated with an IGB for 6 months from 6 months from start. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 30 and ≤45 kg/m^2
- Age 30 to 65 years
Key exclusion criteria (27 listed)
- Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months
- Daily use of meal replacement products within the last 3 months
- Previous gastric surgery
- Current gastric, duodenal or oesophageal ulcers
- Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease
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 |
|---|---|---|
| Low energy diet using meal replacementsAlso: LEDThe LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended. | Dietary supplement | Control group, IGB group |
| CBT-based group treatmentAlso: CBTAll participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants. | Behavioural | Control group, IGB group |
| Intragastric balloonAlso: IGBAn IGB (Orbera IGB, Apollo Endosurgery Inc., Austin, Texas, (CE certified)) is set in place endoscopically by a gastroenterologist at Örebro University Hospital, Region Örebro county, and is left in the stomach for 6 months. A proton-pump inhibitor is prescribed to counteract an increased risk to develop a gastric ulcer. During the first 2 weeks, dietary adjustments are necessary to adapt to the IGB. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended identical to the control group. The IGB is removed endoscopically after 6 months IGB treatment. | Device | IGB group |
Primary outcome
Weight loss in percent of total body weight
Time frame: Change from baseline at 12 months
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
27 secondary outcomes
Weight loss in percent of total body weight
Time frame: Change from baseline at 6 months
Weight loss in percent of total body weight at 2-year follow-up
Time frame: Change from baseline at 24 months
The proportion of participants with ≥5 percent reduction of total body weight from baseline
Time frame: 6, 12 and 24 months
The proportion of participants with ≥10 percent reduction of total body weight from baseline
Time frame: 6, 12 and 24 months
The proportion of participants with ≥15 percent reduction of total body weight from baseline
Time frame: 6, 12 and 24 months
Effect of treatment on bioelectrical impedance measurement to assess fat mass
Time frame: Change from baseline at 6, 12 and 24 months
Effect of treatment on bioelectrical impedance measurement to assess muscle mass
Time frame: Change from baseline at 6, 12 and 24 months
Change in waist circumference
Time frame: Change from baseline at 6, 12 and 24 months
Change in 2-hour oral glucose tolerance test
Time frame: Change from baseline at 6 and 12 months
Change in Hemoglobin A1c
Time frame: Change from baseline at 6 and 12 months
Change in serum lipids
Time frame: Change from baseline at 6 and 12 months
Change in insulin
Time frame: Change from baseline at 6 and 12 months
Change in Homeostatic Model Assessment of Insulin Resistance
Time frame: Change from baseline at 6 and 12 months
Change in kidney function
Time frame: Change from baseline at 6 and 12 months
Change in liver transaminases
Time frame: Change from baseline at 6 and 12 months
Change in thrombocytes
Time frame: Change from baseline at 6 and 12 months
Change in blood pressure
Time frame: Change from baseline at 6 and 12 months
Effect of treatment on vibration-controlled transient elastography measurement to assess level of liver steatosis and fibrosis
Time frame: Change from baseline at 6 and 12 months
Effect of treatment on RAND-36 (SF-36) to measure QoL
Time frame: Change from baseline at 6, 12 and 24 months
Effect of treatment on the Obesity-related Problems scale, version 3 (OPv3) to measure weight-related psychosocial functioning
Time frame: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Effects of treatment on the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18V2) items to measure eating behavior
Time frame: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Effects of treatment on hunger and satiety
Time frame: Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks
Effect of treatment on 7-day step count to measure physical activity
Time frame: Change from baseline at 6, 12 and 24 months
Effect of treatment on sitting time and physical activity
Time frame: Change from baseline at 6, 12 and 24 months
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia
Time frame: Change from baseline at 6, 12 and 24 months
The effect of treatment on the use of health care and absence from work during treatment
Time frame: Change from baseline at 6, 12 and 24 months
Calculation of cost-effectiveness of treatment using multi-variable analysis
Time frame: Change from baseline at 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Johan Jendle, Professor principal investigator
johan.jendle@oru.se
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy diet using meal replacements, CBT-based group treatment and Intragastric balloon in people with Obesity and Weight Loss, 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 2 inclusion and 27 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 18 Jan 2020. 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 Marije Galavazi, PhD, MD (+46196026631, marije.galavazi@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss in percent of total body weight (time frame: Change from baseline at 12 months). 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 18 Jan 2020.