Optimal Dietary Treatment of Obese Adults (OPDIOS)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Holstebro, Denmark, 7500
- Department of Nutrition, Regional Hospital West Jutland, Denmark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI ≥ 25
- Waist: female ≥ 88 cm; male ≥ 102 cm)
- Stable weight for the past three month (+- 5 kilogram)
- Motivated to make changes in their dietary habits
Exclusion Criteria:
- Waist > 150 cm
- Significant cardiovascular, renal or endocrine disease
- Psychiatric history
- Treatment with steroids
- Alcohol- or drug-addiction
- Pregnancy or lactation
- Obesity surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard dietary treatment (STD)
Dietary treatment - 6 individual sessions with a registered dietitian
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This group will receive 6 one-on-one sessions with a registered dietitian.
Total time spent is 6½ hour.
Dietary treatment is based national guidelines and counseling is individualized and tailored to the patient's needs and goals.
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Experimental: "Ned i vaegt" (NIV)
Dietary treatment - 3 individual sessions and 3 group sessions.
All sessions with a registered dietitian.
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This group will receive 3 individual sessions and 3 group sessions.
All sessions are with a registered dietitian.
Total time spent is 15½ hour.
The group sessions consist of 1 hour theory and 2½ hour cooking skills.
The whole intervention is based on a danish self-help weightloss book which is based on the national dietary guidelines.
Focus is to learn to make "normal" danish dishes in a more healthy way both ingredients, cooking, composition and quantity.
They also learn about changing habits, making realistic goals and using their motivation.
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Experimental: "Verdens bedste kur" (VBK)
Dietary treatment - 3 individual sessions and 3 group sessions.
All sessions with a registered dietitian.
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This group will receive 3 individual sessions and 3 group sessions.
All sessions are with a registered dietitian.
Total time spent is 15½ hour.
The group sessions consist of 1 hour theory and 2½ hour cooking skills.
The whole intervention is based on a danish self-help weightloss book which is based on "new nordic diet" and are a relative low-GI and high-protein diet.
Focus is to learn to make new healthy dishes both ingredients, cooking and composition.
They also learn about making realistic goals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Body weight
Time Frame: From week 0 to week 52
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From week 0 to week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure
Time Frame: From week 0 to week 52
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Both systolic and diastolic blood pressure
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From week 0 to week 52
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Dexa-scan (body composition)
Time Frame: From week 0 to week 52
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From week 0 to week 52
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Waist circumference
Time Frame: From week 0 to week 52
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From week 0 to week 52
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Biomarkers in blood samples
Time Frame: From week 0 to week 52
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Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c
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From week 0 to week 52
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Quality of life
Time Frame: From week 0 to week 52
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EQ-5D-5L
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From week 0 to week 52
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Dietary intake
Time Frame: From week 0 to week 52
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Diet records
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From week 0 to week 52
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allan S Christensen, MHSc, Department of Nutrition, Regional Hospital West Jutland, Denmark
- Principal Investigator: Lone Viggers, MSc, Department of Nutrition, Regional Hospital West Jutland, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASC-01-2012
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