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Dare to be Satisfied With Food - a Group Treatment Method

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441308
Enrollment
200
Registered
2018-02-22
Start date
2015-09-16
Completion date
2023-06-20
Last updated
2023-06-22

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

Conditions

Overweight and Obesity

Keywords

Dieting, learning to eat, group 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.

Interventions

BEHAVIORALEducational method of group treatment

Sponsors

Kronoberg County Council
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Weight lossFrom baseline to 5 yearsWeight loss of 5 kg or more

Secondary

MeasureTime frameDescription
Improved lipid profileFrom baseline to 5 yearsLower fasting lipid profile (triglycerides/cholesterol)
Improved quality of liveFrom baseline to 5 yearsMeasured 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.
Blood pressure reductionFrom baseline to 5 yearsSystolic and diastolic blood pressure
Body fat percentages reductionFrom baseline to 5 yearsBody fat percentages measured by bioelectrical impedance analysis (BIA)
Urate reductionFrom baseline to 5 yearsLower urate level

Outcome results

None listed

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