Optimal Dietary Treatment of Obese Adults (OPDIOS)
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standard dietary treatment (STD)
"Ned i vaegt" (NIV)
"Verdens bedste kur" (VBK)
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss, Dietary intervention, Self-help book, Cooking, Dietitian, Dietary therapy
Eligibility Criteria
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
Sites / Locations
- Department of Nutrition, Regional Hospital West Jutland, Denmark
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Standard dietary treatment (STD)
"Ned i vaegt" (NIV)
"Verdens bedste kur" (VBK)
Arm Description
Dietary treatment - 6 individual sessions with a registered dietitian
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Blood pressure
Both systolic and diastolic blood pressure
Dexa-scan (body composition)
Waist circumference
Biomarkers in blood samples
Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c
Quality of life
EQ-5D-5L
Dietary intake
Diet records
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01685957
Brief Title
Optimal Dietary Treatment of Obese Adults
Acronym
OPDIOS
Official Title
Optimal Dietary Treatment of Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitalsenheden Vest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Weight loss, Dietary intervention, Self-help book, Cooking, Dietitian, Dietary therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard dietary treatment (STD)
Arm Type
Active Comparator
Arm Description
Dietary treatment - 6 individual sessions with a registered dietitian
Arm Title
"Ned i vaegt" (NIV)
Arm Type
Experimental
Arm Description
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
Arm Title
"Verdens bedste kur" (VBK)
Arm Type
Experimental
Arm Description
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
Intervention Type
Behavioral
Intervention Name(s)
Standard dietary treatment (STD)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
"Ned i vaegt" (NIV)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
"Verdens bedste kur" (VBK)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Time Frame
From week 0 to week 52
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Both systolic and diastolic blood pressure
Time Frame
From week 0 to week 52
Title
Dexa-scan (body composition)
Time Frame
From week 0 to week 52
Title
Waist circumference
Time Frame
From week 0 to week 52
Title
Biomarkers in blood samples
Description
Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c
Time Frame
From week 0 to week 52
Title
Quality of life
Description
EQ-5D-5L
Time Frame
From week 0 to week 52
Title
Dietary intake
Description
Diet records
Time Frame
From week 0 to week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan S Christensen, MHSc
Organizational Affiliation
Department of Nutrition, Regional Hospital West Jutland, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lone Viggers, MSc
Organizational Affiliation
Department of Nutrition, Regional Hospital West Jutland, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Regional Hospital West Jutland, Denmark
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
12. IPD Sharing Statement
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Optimal Dietary Treatment of Obese Adults
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