"Dare to be Satisfied With Food" - a Group Treatment Method

Overweight and Obesity Clinical Trial

Official title:

"Dare to be Satisfied With Food" - a Group Treatment Method for Sustainable Weight Reduction in Adults With BMI 27-45

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441308
• Other study ID #: FORSS-752611
• Status: Completed
• Phase: N/A
• Start date: September 16, 2015
• Est. completion date: June 20, 2023

Study information

• Verified date: June 2023
• Source: Kronoberg County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The concept "Dare to be satisfied with food" is an educational method of group treatment based on regular meals and food based on Nordic nutrition recommendations. The method has been developed by a district nurse at the city of Ljungby, Sweden and has shown permanent weight loss in a limited number of persons who tested the method. It is important to test the method scientifically and in the long term for possible implementation in routine activities in the healthcare sector. Adults with overweight and obesity (BMI 27-45) will be recruited to the study by announcing in newspapers in the counties of Kronoberg and Kalmar and then randomized to intervention group and control group, where the control group receives dietary advice according to the Swedish National Food Agency's guidelines for overweight and obesity (including brochures).

Description:

The incidence of obesity among adults in Sweden has more than doubled since the 1980s, and the trend seems to continue according to figures from the Public Health Authority (2013), which showed that of the adult population 35% were overweight and 15% obese. Obesity raises the risk of severe diseases such as cardiovascular disease, type 2 diabetes and some cancers. Arthritis, gallstones and childlessness are also common in obese people. In the field of health care, the views differ as to which dietary advice is best for obese people. Swedish Agency For Health Technology Assessment and Assessment of Social Services (SBU, 2013) review of the overall research shows that several types of dietary advice can lead to weight loss. In the long term, councils were equivalent to weight loss, while in the short term a difference between costs was different. As for beverages, a slight intake of sweet drinks showed a weight loss. For some people low blood sugar can lead to uncontrolled eating and were the gateway to improper eating habits.

The aim is to study the effect of the "Dare to be satisfied with food concept" for weight loss with five years follow-up compared to now recommended short counseling according to the Swedish National Food Agency's recommendations.

Participants in the project will be recruited through advertising I newspapers in the counties of Kronoberg and Kalmar. Anyone who meets the criteria and wishes to attend a telephone interview will receive an information letter together with an informed consent form to return. Thereafter, the persons are randomized to the intervention or control group in blocks of 20. The intervention group is offered 10 meetings in groups of 6-8 participants over 6 months. Group meeting 5 includes a short individual consultation. In addition, individual consultation and sampling after group meeting 1 and 10. The control group is offered dietary advise according to the Swedish Food Authority's guidelines for overweight and obesity (including brochures) on an individual occasion including blood samples at the start and after 6 months. At the first visit, a survey is conducted on questions about background factors, living habits, quality of life, health and disease. Sampling includes length, weight, waist and seat measurements, blood pressure, heart rate, blood samples (blood value, blood lipids, metabolism, long-term sugar, electrolytes and liver and kidney function.Then follow-up once yearly for five years for both groups with surveys and sampling in the same way.

Power calculation: At alpha 0.05 and beta 0.2 (power 0.8) 65 people must be randomized in each group to find a weight difference of at least 5 kg. Considering a drop out of about 1/3, 100 people need to be randomized to each group.

Statistical analysis will be done according to intention to treat with major outcome weight loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 20, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) 27-45

• Speaks the Swedish language

• Residents of Kronoberg or Kalmar county

Exclusion Criteria:

• Insulin-treated diabetes

• Severe mental illness

• Severe liver disease

• Severe kidney disease

• Heart failure grade 3-4

• Other serious generalized disease

• Multiple food allergy.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Educational method of group treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kronoberg County Council

References & Publications (5)

Holm S. Obesity interventions and ethics. Obes Rev. 2007 Mar;8 Suppl 1:207-10. doi: 10.1111/j.1467-789X.2007.00343.x. No abstract available. — View Citation

Karnehed N, Rasmussen F, Hemmingsson T, Tynelius P. Obesity and attained education: cohort study of more than 700,000 Swedish men. Obesity (Silver Spring). 2006 Aug;14(8):1421-8. doi: 10.1038/oby.2006.161. — View Citation

Lewis S, Thomas SL, Blood RW, Castle DJ, Hyde J, Komesaroff PA. How do obese individuals perceive and respond to the different types of obesity stigma that they encounter in their daily lives? A qualitative study. Soc Sci Med. 2011 Nov;73(9):1349-56. doi: 10.1016/j.socscimed.2011.08.021. Epub 2011 Sep 10. — View Citation

Nygardh A, Malm D, Wikby K, Ahlstrom G. The experience of empowerment in the patient-staff encounter: the patient's perspective. J Clin Nurs. 2012 Mar;21(5-6):897-904. doi: 10.1111/j.1365-2702.2011.03901.x. Epub 2011 Nov 15. — View Citation

Zhang C, Rexrode KM, van Dam RM, Li TY, Hu FB. Abdominal obesity and the risk of all-cause, cardiovascular, and cancer mortality: sixteen years of follow-up in US women. Circulation. 2008 Apr 1;117(13):1658-67. doi: 10.1161/CIRCULATIONAHA.107.739714. Epub 2008 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight loss of 5 kg or more	From baseline to 5 years
Secondary	Improved lipid profile	Lower fasting lipid profile (triglycerides/cholesterol)	From baseline to 5 years
Secondary	Improved quality of live	Measured with standard Visual Analog Scale from 0 to100 based on a numeric Likert scale (0 = "very low quality of life", and 100 = "highest possible quality of life"), i.e. Higher scores indicate higher quality of life.	From baseline to 5 years
Secondary	Blood pressure reduction	Systolic and diastolic blood pressure	From baseline to 5 years
Secondary	Body fat percentages reduction	Body fat percentages measured by bioelectrical impedance analysis (BIA)	From baseline to 5 years
Secondary	Urate reduction	Lower urate level	From baseline to 5 years

External Links

•   New Nordic Nutrition Recommendations are here. Food & Nutrition Research
•   Swedish Council on Health Technology Assessment.Food with adiposity: a systematic literature review (SBU report) [2013]
•   The Public Health Agency of Sweden (2017). National Public Health Data:overweight and adiposity.[2017-02-26]