Optimal Dietary Treatment of Obese Adults

Obesity Clinical Trial

— OPDIOS  

Official title:

Optimal Dietary Treatment of Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685957
• Other study ID #: ASC-01-2012
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2016

Study information

• Verified date: May 2018
• Source: Hospitalsenheden Vest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Standard dietary treatment (STD)
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.
• "Ned i vaegt" (NIV)
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.
• "Verdens bedste kur" (VBK)
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.

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Regional Hospital West Jutland, Denmark	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Hospitalsenheden Vest

Country where clinical trial is conducted

Denmark, 

Outcome

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