Optimal Dietary Treatment of Obese Adults
OPDIOS
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Oct 2012
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMay 21, 2018
May 1, 2018
4 years
September 12, 2012
May 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body weight
From week 0 to week 52
Secondary Outcomes (6)
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
From week 0 to week 52
Quality of life
From week 0 to week 52
- +1 more secondary outcomes
Study Arms (3)
Standard dietary treatment (STD)
ACTIVE COMPARATORDietary treatment - 6 individual sessions with a registered dietitian
"Ned i vaegt" (NIV)
EXPERIMENTALDietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
"Verdens bedste kur" (VBK)
EXPERIMENTALDietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
Interventions
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.
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Waist \> 150 cm
- Significant cardiovascular, renal or endocrine disease
- Psychiatric history
- Treatment with steroids
- Alcohol- or drug-addiction
- Pregnancy or lactation
- Obesity surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition, Regional Hospital West Jutland, Denmark
Holstebro, 7500, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MHSc, RD
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 14, 2012
Study Start
October 1, 2012
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
May 21, 2018
Record last verified: 2018-05