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

June 19, 2023 updated by: Kronoberg County Council

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Educational method of group treatment
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 Ljungby. Ten meetings in groups of 6-8 participants over 6 months. Group meeting number 5 includes short individual consultations. In addition, individual consultation after group meeting 1 and 10.
Behavioral: Educational method of group treatment
Other Names:
  • Dietary advice
Placebo Comparator: Dietary advice
The control group is offered dietary advice according to the Swedish National Food Agency's guidelines for overweight and obesity (including brochures) at one occasion.
Behavioral: Educational method of group treatment
Other Names:
  • Dietary advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: From baseline to 5 years
Weight loss of 5 kg or more
From baseline to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved lipid profile
Time Frame: From baseline to 5 years
Lower fasting lipid profile (triglycerides/cholesterol)
From baseline to 5 years
Improved quality of live
Time Frame: From baseline to 5 years
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
Blood pressure reduction
Time Frame: From baseline to 5 years
Systolic and diastolic blood pressure
From baseline to 5 years
Body fat percentages reduction
Time Frame: From baseline to 5 years
Body fat percentages measured by bioelectrical impedance analysis (BIA)
From baseline to 5 years
Urate reduction
Time Frame: From baseline to 5 years
Lower urate level
From baseline to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kronoberg County Council

Investigators

  • Study Director: Lena Lendahls, PhD, Kronoberg County Council
  • Principal Investigator: Sara Holmberg, MD, PhD, Kronoberg County Council
  • Principal Investigator: Kjell-Ake I Alle, MD, PhD, Kronoberg County Council
  • Study Director: Mari Bergenholz-Liljedal, Nurse, Kronoberg County Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2015

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORSS-752611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data för all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data vill be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by our study group. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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