Optimal Dietary Treatment of Obese Adults

NCT ID: NCT01685957

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard dietary treatment (STD)

Dietary treatment - 6 individual sessions with a registered dietitian

Group Type: ACTIVE_COMPARATOR

Standard dietary treatment (STD)

Intervention Type: 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)

Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

Group Type: EXPERIMENTAL

"Ned i vaegt" (NIV)

Intervention Type: 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)

Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

Group Type: EXPERIMENTAL

"Verdens bedste kur" (VBK)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitalsenheden Vest

OTHER

Sponsor Role: lead

Responsible Party

Allan Stubbe Christensen

MHSc, RD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allan S Christensen, MHSc

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Regional Hospital West Jutland, Denmark

Lone Viggers, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Regional Hospital West Jutland, Denmark

Locations

Department of Nutrition, Regional Hospital West Jutland, Denmark

Holstebro, , Denmark

Countries

Denmark

Other Identifiers

ASC-01-2012

Identifier Type: -

Identifier Source: org_study_id