Optimal Dietary Treatment of Obese Adults (OPDIOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospitalsenheden Vest
Sponsor:
Information provided by (Responsible Party):
Allan Stubbe Christensen, Hospitalsenheden Vest
ClinicalTrials.gov Identifier:
NCT01685957
First received: September 12, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity
Overweight
Behavioral: Standard dietary treatment (STD)
Behavioral: "Ned i vaegt" (NIV)
Behavioral: "Verdens bedste kur" (VBK)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Dietary Treatment of Obese Adults

Resource links provided by NLM:


Further study details as provided by Hospitalsenheden Vest:

Primary Outcome Measures:
  • Body weight [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]
    Both systolic and diastolic blood pressure

  • Dexa-scan (body composition) [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]
  • Biomarkers in blood samples [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]
    Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c

  • Quality of life [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]
    EQ-5D-5L

  • Dietary intake [ Time Frame: From week 0 to week 52 ] [ Designated as safety issue: No ]
    Diet records


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685957

Contacts
Contact: Allan S Christensen, MHSc +45 7843 4500 allan.christensen@vest.rm.dk
Contact: Birthe Petersen +45 7843 4500 birthe.petersen@vest.rm.dk

Locations
Denmark
Department of Nutrition, Regional Hospital West Jutland, Denmark Recruiting
Holstebro, Denmark, 7500
Contact: Birthe Petersen    +45 78434500    birthe.petersen@vest.rm.dk   
Contact: Janni E Staunstrup    +45 78434500    jannie.ejgod.staunstrup@vest.rm.dk   
Principal Investigator: Allan S Christensen, MHSc         
Principal Investigator: Lone Viggers, MSc         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Allan Stubbe Christensen, MHSc, RD, Hospitalsenheden Vest
ClinicalTrials.gov Identifier: NCT01685957     History of Changes
Other Study ID Numbers: ASC-01-2012
Study First Received: September 12, 2012
Last Updated: February 27, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hospitalsenheden Vest:
Weight loss
Dietary intervention
Self-help book
Cooking
Dietitian
Dietary therapy

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014