Obesity Treatment With LCD in Primary Health Care

NCT01608191 | Completed

• 2 other identifiers: OCC-LCD-PV2011/434
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• • 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%

  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

  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

  From baseline to 1 year

• Quality of life improvements in both groups compared with baseline at one year

  baseline to 1 year

Study Arms (2)

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.

Behavioral: CBT follow up

Interventions

CBT follow up BEHAVIORAL

11 weeks programme conducted via internet. CBT with focus on weight stability.

CBT follow up

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro County Council: lead

Study Sites (1)

Orebro County Council

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jan Karlsson

  Universitetssjukvårdens forskningscentrum, UFC, Region Örebro län, Box 1613, 70116 Örebro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Behaviorist

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 30, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)