Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Obesity Treatment With LCD in Primary Health Care (LCD-KBT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Örebro County Council
Sponsor:
Information provided by (Responsible Party):
Johanna Sjolander MD, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01608191
First received: May 25, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Weight Loss
Behavioral: CBT follow up
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]
    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%


Secondary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]
    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.

  • Improved metabolic control (lower weight and waist circumference, lower TGA) Higher HDL, lower Hba1c [ Time Frame: From baseline to 1 year ] [ Designated as safety issue: No ]
    • 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.

  • Quality of life improvements in both groups compared with baseline at one year [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]

    • 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.



Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Ordinary primary care follow up
Ordinary follow up after 24 weeks of LCD diet + reintroduction of food.
Active Comparator: CBT follow up
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608191

Locations
Sweden
Orebro County Council Recruiting
Orebro, Sweden, 70185
Contact: Johanna Sjolander, Med dr    +46-19 6026630    johanna.sjolander@orebroll.se   
Contact: Peter Engfeldt, Professor    +46-19 6025789    peter.engfeldt@orebroll.se   
Principal Investigator: Johanna Sjolander, Dr         
Principal Investigator: Peter Engfeldt, Professor         
Sponsors and Collaborators
Örebro County Council
Investigators
Study Chair: Peter Engfeldt, Professor Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, BOX 1613, 70116 Örebro
  More Information

No publications provided

Responsible Party: Johanna Sjolander MD, Gen Pract., Örebro County Council
ClinicalTrials.gov Identifier: NCT01608191     History of Changes
Other Study ID Numbers: OCC-LCD-PV, 2011/434
Study First Received: May 25, 2012
Last Updated: January 22, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014