ObesityOPDIOSNCT01685957
Optimal Dietary Treatment of Obese Adults
A study testing Standard dietary treatment (STD), "Ned i vaegt" (NIV) and "Verdens bedste kur" (VBK) in people with Obesity and Overweight, run by Hospitalsenheden Vest at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Standard dietary treatment (STD), "Ned i vaegt" (NIV) and "Verdens bedste kur" (VBK)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Waist > 150 cm
- Significant cardiovascular, renal or endocrine disease
- Psychiatric history
- Treatment with steroids
- Alcohol- or drug-addiction
- Pregnancy or lactation
- Obesity surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Regional Hospital West Jutland, Denmark
Holstebro, 7500
About this study
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.
- Conditions
- Obesity, Overweight
- Being tested
- Standard dietary treatment (STD), "Ned i vaegt" (NIV), "Verdens bedste kur" (VBK)
- Keywords
- Weight loss, Dietary intervention, Self-help book, Cooking, Dietitian, Dietary therapy
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dietary treatment (STD)Behavioural
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.
"Ned i vaegt" (NIV)Behavioural
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.
"Verdens bedste kur" (VBK)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard dietary treatment (STD) | Active comparator | Dietary treatment - 6 individual sessions with a registered dietitian Receives: Behavioral: Standard dietary treatment (STD) |
| "Ned i vaegt" (NIV) | Experimental | Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian. Receives: Behavioral: "Ned i vaegt" (NIV) |
| "Verdens bedste kur" (VBK) | Experimental | Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian. Receives: Behavioral: "Verdens bedste kur" (VBK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: From week 0 to week 52
Secondary outcomes (6)
Blood pressure
Both systolic and diastolic blood pressure
Measured: From week 0 to week 52
Dexa-scan (body composition)
Measured: From week 0 to week 52
Waist circumference
Measured: From week 0 to week 52
Biomarkers in blood samples
Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c
Measured: From week 0 to week 52
Quality of life
EQ-5D-5L
Measured: From week 0 to week 52
Dietary intake
Diet records
Measured: From week 0 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitalsenheden Vest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Stubbe Christensen, Hospitalsenheden Vest
- Investigators
- Allan S Christensen, MHSc, Principal investigator, Department of Nutrition, Regional Hospital West Jutland, DenmarkLone Viggers, MSc, Principal investigator, Department of Nutrition, Regional Hospital West Jutland, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685957
- Sponsor's protocol ID
- ASC-01-2012
- Acronym
- OPDIOS
- Status last verified
- May 2018
- First submitted
- 12 Sep 2012
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dietary Treatment of Obese Adults
- ClinicalTrials.gov ID
- NCT01685957
- Acronym / sponsor ID
- OPDIOS / ASC-01-2012
- Conditions
- Obesity, Overweight
- Keywords
- Weight loss, Dietary intervention, Self-help book, Cooking, Dietitian, Dietary therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospitalsenheden VestUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dietary treatment (STD) | Active comparator | Behavioral: Standard dietary treatment (STD)Dietary treatment - 6 individual sessions with a registered dietitian |
| "Ned i vaegt" (NIV) | Experimental | Behavioral: "Ned i vaegt" (NIV)Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian. |
| "Verdens bedste kur" (VBK) | Experimental | Behavioral: "Verdens bedste kur" (VBK)Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Waist > 150 cm
- Significant cardiovascular, renal or endocrine disease
- Psychiatric history
- Treatment with steroids
- Alcohol- or drug-addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard dietary treatment (STD) |
| "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. | Behavioural | "Ned i vaegt" (NIV) |
| "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. | Behavioural | "Verdens bedste kur" (VBK) |
Primary outcome
Body weight
Time frame: From week 0 to week 52
6 secondary outcomes
Blood pressure
Time frame: From week 0 to week 52
Dexa-scan (body composition)
Time frame: From week 0 to week 52
Waist circumference
Time frame: From week 0 to week 52
Biomarkers in blood samples
Time frame: From week 0 to week 52
Quality of life
Time frame: From week 0 to week 52
Dietary intake
Time frame: From week 0 to week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan S Christensen, MHSc principal investigator
Department of Nutrition, Regional Hospital West Jutland, Denmark
Lone Viggers, MSc principal investigator
Department of Nutrition, Regional Hospital West Jutland, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard dietary treatment (STD), "Ned i vaegt" (NIV) and "Verdens bedste kur" (VBK) in people with Obesity and Overweight, run by Hospitalsenheden Vest at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: From week 0 to week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.