Optimal Dietary Treatment of Obese Adults

Study Overview
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Brief Summary
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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.

Official Title
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Optimal Dietary Treatment of Obese Adults

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Standard dietary treatment (STD)
* Behavioral: Ned i vaegt (NIV)
* Behavioral: Verdens bedste kur (VBK)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dietary treatment (STD)<br>Dietary treatment - 6 individual sessions with a registered dietitian | Behavioral: Standard dietary treatment (STD)<br>* 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.<br>|
| Experimental: Ned i vaegt (NIV)<br>Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian. | Behavioral: Ned i vaegt (NIV)<br>* 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.<br>|
| Experimental: Verdens bedste kur (VBK)<br>Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian. | Behavioral: Verdens bedste kur (VBK)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | From week 0 to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Both systolic and diastolic blood pressure | From week 0 to week 52 | 
| Dexa-scan (body composition) |  | From week 0 to week 52 | 
| Waist circumference |  | From week 0 to week 52 | 
| Biomarkers in blood samples | Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c | From week 0 to week 52 | 
| Quality of life | EQ-5D-5L | From week 0 to week 52 | 
| Dietary intake | Diet records | From week 0 to week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Dietary intervention, Self-help book, Cooking, Dietitian, Dietary therapy