Optimal Dietary Treatment of Obese Adults (OPDIOS)

Hospitalsenheden Vest

Status: Completed

Conditions: Overweight; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01685957

ASC-01-2012

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 3 patient groups

Standard dietary treatment (STD)

Active Comparator group

Description:

Dietary treatment - 6 individual sessions with a registered dietitian

Treatment:

Behavioral: Standard dietary treatment (STD)

"Ned i vaegt" (NIV)

Experimental group

Description:

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

Treatment:

Behavioral: "Ned i vaegt" (NIV)

"Verdens bedste kur" (VBK)

Experimental group

Description:

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

Treatment:

Behavioral: "Verdens bedste kur" (VBK)