Optimal Dietary Treatment of Obese Adults

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Standard dietary treatment (STD); Behavioral: "Ned i vaegt" (NIV); Behavioral: "Verdens bedste kur" (VBK)

• Registration Number: NCT01685957
• Lead Sponsor: Hospitalsenheden Vest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Study Start: 2012-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dietary treatment (STD)	Standard dietary treatment (STD)	Dietary treatment - 6 individual sessions with a registered dietitian
"Ned i vaegt" (NIV)	"Ned i vaegt" (NIV)	Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
"Verdens bedste kur" (VBK)	"Verdens bedste kur" (VBK)	Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

Primary Outcome Measures

Name	Time	Method
Body weight	From week 0 to week 52

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nutrition, Regional Hospital West Jutland, Denmark; 🇩🇰 Holstebro, Denmark