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Completed

NCT Number: NCT01685957

Optimal Dietary Treatment of Obese Adults

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Regional Hospital West Jutland, Denmark

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard dietary treatment (STD)

Behavioral

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)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Body weight

    Time frame: From week 0 to week 52

Secondary outcomes

  1. Blood pressure

    Time frame: From week 0 to week 52

    Both systolic and diastolic blood pressure

  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

    Time frame: From week 0 to week 52

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

  5. Quality of life

    Time frame: From week 0 to week 52

    EQ-5D-5L

  6. Dietary intake

    Time frame: From week 0 to week 52

    Diet records

Sponsors and collaborators

Lead sponsor

Hospitalsenheden Vest

Other

Registry information

Acronym: OPDIOS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2012
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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