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Optimal Dietary Treatment of Obese Adults

Optimal Dietary Treatment of Obese Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01685957
Acronym
OPDIOS
Enrollment
120
Registered
2012-09-14
Start date
2012-10-31
Completion date
2016-10-31
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Weight loss, Dietary intervention, Self-help book, Cooking, Dietitian, Dietary therapy

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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALNed 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.

BEHAVIORALVerdens 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.

Sponsors

Hospitalsenheden Vest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Body weightFrom week 0 to week 52

Secondary

MeasureTime frameDescription
Dexa-scan (body composition)From week 0 to week 52
Waist circumferenceFrom week 0 to week 52
Blood pressureFrom week 0 to week 52Both systolic and diastolic blood pressure
Quality of lifeFrom week 0 to week 52EQ-5D-5L
Dietary intakeFrom week 0 to week 52Diet records
Biomarkers in blood samplesFrom week 0 to week 52Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026