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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Department of Nutrition, Regional Hospital West Jutland, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospitalsenheden Vest
• 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): October 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Weight loss; Dietary intervention; Cooking; Dietitian; Self-help book; Dietary therapy
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: ASC-01-2012