OPDIOS: Optimal Dietary Treatment of Obese Adults

• Sponsor: Hospitalsenheden Vest (Other)
• Overall Status: Completed
• CT.gov ID: NCT01685957
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Actual Duration (Months): 48
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight	Behavioral: Standard dietary treatment (STD); Behavioral: "Ned i vaegt" (NIV); Behavioral: "Verdens bedste kur" (VBK)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Optimal Dietary Treatment of Obese Adults
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard dietary treatment (STD) Dietary treatment - 6 individual sessions with a registered dietitian	Behavioral: 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: "Ned i vaegt" (NIV) Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.	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.
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); 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.

Outcome Measures

Primary Outcome Measures

1. Body weight [From week 0 to week 52]

Secondary Outcome Measures

1. Blood pressure [From week 0 to week 52]

   Both systolic and diastolic blood pressure

2. Dexa-scan (body composition) [From week 0 to week 52]

3. Waist circumference [From week 0 to week 52]

4. Biomarkers in blood samples [From week 0 to week 52]

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

5. Quality of life [From week 0 to week 52]

   EQ-5D-5L

6. Dietary intake [From week 0 to week 52]

   Diet records

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

• Waist > 150 cm

• Significant cardiovascular, renal or endocrine disease

• Psychiatric history

• Treatment with steroids

• Alcohol- or drug-addiction

• Pregnancy or lactation

• Obesity surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition, Regional Hospital West Jutland, Denmark	Holstebro		Denmark	7500

Sponsors and Collaborators

• Hospitalsenheden Vest

Investigators

• Principal Investigator: Allan S Christensen, MHSc, Department of Nutrition, Regional Hospital West Jutland, Denmark
• Principal Investigator: Lone Viggers, MSc, Department of Nutrition, Regional Hospital West Jutland, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allan Stubbe Christensen, MHSc, RD, Hospitalsenheden Vest
• ClinicalTrials.gov Identifier: NCT01685957
• Other Study ID Numbers: ASC-01-2012
• First Posted: Sep 14, 2012
• Last Update Posted: May 21, 2018
• Last Verified: May 1, 2018

• Keywords provided by Allan Stubbe Christensen, MHSc, RD, Hospitalsenheden Vest: Weight loss; Dietary intervention; Self-help book; Cooking; Dietitian; Dietary therapy
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of May 21, 2018