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

NCT03441308 | Completed DMC

• 1 other identifier: FORSS-752611
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Overweight and Obesity

Keywords

Dieting; learning to eat; group treatment

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight loss of 5 kg or more

  From baseline to 5 years

Secondary Outcomes (5)

• Improved lipid profile

  From baseline to 5 years

• Improved quality of live

  From baseline to 5 years

• Blood pressure reduction

  From baseline to 5 years

• Body fat percentages reduction

  From baseline to 5 years

• Urate reduction

  From baseline to 5 years

Study Arms (2)

Educational method of group treatment

ACTIVE COMPARATOR

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

Dietary advice

PLACEBO COMPARATOR

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

Interventions

Educational method of group treatment BEHAVIORAL

Also known as: Dietary advice

Dietary advice; Educational method of group treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) 27-45
• Speaks the Swedish language
• Residents of Kronoberg or Kalmar county

You may not qualify if:

• Insulin-treated diabetes
• Severe mental illness
• Severe liver disease
• Severe kidney disease
• Heart failure grade 3-4
• Other serious generalized disease
• Multiple food allergy.

Sponsors & Collaborators

• Kronoberg County Council: lead

Related 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.

  PMID: 17316327 BACKGROUND

• 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.

  PMID: 16988085 BACKGROUND

• 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.

  PMID: 21944718 BACKGROUND

• 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.

  PMID: 18362231 BACKGROUND

• 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.

  PMID: 22081948 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lena Lendahls, PhD

  Kronoberg County Council

  STUDY DIRECTOR

• Sara Holmberg, MD, PhD

  Kronoberg County Council

  PRINCIPAL INVESTIGATOR

• Kjell-Ake I Alle, MD, PhD

  Kronoberg County Council

  PRINCIPAL INVESTIGATOR

• Mari Bergenholz-Liljedal, Nurse

  Kronoberg County Council

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: February 22, 2018
• Study Start: September 16, 2015
• Primary Completion: June 30, 2022
• Study Completion: June 20, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data vill be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by our study group. Requestors will be required to sign a Data Access Agreement.