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Clinical Trials/NCT01685957
NCT01685957
Completed
Not Applicable

Optimal Dietary Treatment of Obese Adults

Hospitalsenheden Vest1 site in 1 country120 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Hospitalsenheden Vest
Enrollment
120
Locations
1
Primary Endpoint
Body weight
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospitalsenheden Vest
Responsible Party
Principal Investigator
Principal Investigator

Allan Stubbe Christensen

MHSc, RD

Hospitalsenheden Vest

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Body weight

Time Frame: From week 0 to week 52

Secondary Outcomes

  • Dietary intake(From week 0 to week 52)
  • 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)

Study Sites (1)

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