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Obesity Treatment With LCD in Primary Health Care

NCT01608191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2018-09-17

No results posted yet for this study

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

Interventions

BEHAVIORAL

CBT follow up

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

Sponsors & Collaborators

  • Örebro County Council

    lead OTHER_GOV

Principal Investigators

  • Jan Karlsson · Universitetssjukvårdens forskningscentrum, UFC, Region Örebro län, Box 1613, 70116 Örebro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608191 on ClinicalTrials.gov