Completed

OPDIOSOptimal Dietary Treatment of Obese Adults

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What is being tested

Standard dietary treatment (STD)

+ "Ned i vaegt" (NIV)

+ "Verdens bedste kur" (VBK)

Behavioral
Who is being recruted

Body Weight+7

+ Body Weight Changes

+ Nutrition Disorders

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorHospitalsenheden Vest
Last updated: May 21, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

Recent decades have shown an alarming increase in obesity. Obesity is associated with high costs for both the individual and for society. It is therefore important to prevent and treat obesity. The investigators believe that if you add a self-help weightloss book and teach cooking skills to a standard dietary treatment, then it will result in greater weight loss than with dietary treatment alone. However, this has not yet been studied. Since it will require more resources, it is important to investigate whether it also works better before changing the current treatment. Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and cooking classes are more effective than dietary treatment alone in changes in body weight and body composition in obese persons over a period of 12 months. There is no difference if the intervention are based on the national dietary guidelines or a relative low-gi and high-protein diet. Secondary to investigate the impact the interventions have; on diet quality and quantity, on markers of metabolic syndrome and on how many subjects complete the study.

Principal SponsorHospitalsenheden Vest
Last updated: May 21, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionObesityWeight LossOverweight

Criteria

4 inclusion criteria required to participate
BMI >= 25

Motivated to make changes in their dietary habits

Stable weight for the past three month (+- 5 kilogram)

Waist: female >= 88 cm; male >= 102 cm)

7 exclusion criteria prevent from participating
Alcohol- or drug-addiction

Obesity surgery

Pregnancy or lactation

Psychiatric history

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Dietary treatment - 6 individual sessions with a registered dietitian

Group II

Experimental
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

Group III

Experimental
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Nutrition, Regional Hospital West Jutland, Denmark

Holstebro, DenmarkOpen Department of Nutrition, Regional Hospital West Jutland, Denmark in Google Maps
CompletedOne Study Center