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CompletedNCT01685957OPDIOSUpdated May 21, 2018

Optimal Dietary Treatment of Obese Adults

An interventional study of Standard dietary treatment (STD) and "Ned i vaegt" (NIV) in Obesity and Overweight, sponsored by Hospitalsenheden Vest. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Hospitalsenheden Vest · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight

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Keywords

  • Weight loss
  • Dietary intervention
  • Self-help book
  • Cooking
  • Dietitian
  • Dietary therapy
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 120 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Hospitalsenheden Vest is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Standard dietary treatment (STD)

    Dietary treatment - 6 individual sessions with a registered dietitian

    Behavioral: Standard dietary treatment (STD)

  • 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)

  • 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)

Interventions

  • BehavioralStandard 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.

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Body weight

    Time frame: From week 0 to week 52

Secondary outcomes

  1. Blood pressure

    Both systolic and diastolic blood pressure

    Time frame: From week 0 to week 52

  2. Dexa-scan (body composition)

    Time frame: From week 0 to week 52

  3. Waist circumference

    Time frame: From week 0 to week 52

  4. Biomarkers in blood samples

    Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c

    Time frame: From week 0 to week 52

  5. Quality of life

    EQ-5D-5L

    Time frame: From week 0 to week 52

  6. Dietary intake

    Diet records

    Time frame: From week 0 to week 52

07

Study locations

1 site
  • Department of Nutrition, Regional Hospital West Jutland, Denmark
    Holstebro, 7500, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01685957
Lead sponsor
Hospitalsenheden Vest
Responsible party
Allan Stubbe Christensen (MHSc, RD, Hospitalsenheden Vest) — Principal investigator
First posted
Sep 14, 2012
Start date
Oct 2012
Primary completion
Oct 2016
Completion
Oct 2016
Last update
May 21, 2018

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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