Clinical trial NCT03441308: "Dare to be Satisfied With Food" - a Group Treatment Method
Official title: "Dare to be Satisfied With Food" - a Group Treatment Method for Sustainable Weight Reduction in Adults With BMI 27-45
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Dieting
learning to eat
group treatment
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
First posted: 2018-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss
timeFrame: From baseline to 5 years
Secondary outcomes:
measure: Improved lipid profile
timeFrame: From baseline to 5 years
measure: Improved quality of live
timeFrame: From baseline to 5 years
measure: Blood pressure reduction
timeFrame: From baseline to 5 years
measure: Body fat percentages reduction
timeFrame: From baseline to 5 years
measure: Urate reduction
timeFrame: From baseline to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Kronoberg County Council
name: Lena Lendahls, PhD
role: STUDY_DIRECTOR
affiliation: Kronoberg County Council
name: Sara Holmberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kronoberg County Council
name: Kjell-Ake I Alle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kronoberg County Council
name: Mari Bergenholz-Liljedal, Nurse
role: STUDY_DIRECTOR
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