Overview

This trial has been completed.

Conditions obesity, overweight
Treatments standard dietary treatment (std), "ned i vaegt" (niv), "verdens bedste kur" (vbk)
Sponsor Hospitalsenheden Vest
Start date October 2012
End date October 2016
Trial size 120 participants
Trial identifier NCT01685957, ASC-01-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Dietary treatment - 6 individual sessions with a registered dietitian
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.
(Experimental)
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
"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.
(Experimental)
Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
"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.

Primary Outcomes

Measure
Body weight
time frame: From week 0 to week 52

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Optimal Dietary Treatment of Obese Adults
Principal investigator Allan S Christensen, MHSc
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hospitalsenheden Vest.