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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational method of group treatment
Sponsored by
Kronoberg County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Dieting, learning to eat, group treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Educational method of group treatment

    Dietary advice

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Weight loss
    Weight loss of 5 kg or more

    Secondary Outcome Measures

    Improved lipid profile
    Lower fasting lipid profile (triglycerides/cholesterol)
    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.
    Blood pressure reduction
    Systolic and diastolic blood pressure
    Body fat percentages reduction
    Body fat percentages measured by bioelectrical impedance analysis (BIA)
    Urate reduction
    Lower urate level

    Full Information

    First Posted
    December 18, 2017
    Last Updated
    June 19, 2023
    Sponsor
    Kronoberg County Council
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03441308
    Brief Title
    "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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 16, 2015 (Actual)
    Primary Completion Date
    June 30, 2022 (Actual)
    Study Completion Date
    June 20, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kronoberg County Council

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity
    Keywords
    Dieting, learning to eat, group treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational method of group treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Dietary advice
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational method of group treatment
    Other Intervention Name(s)
    Dietary advice
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight loss of 5 kg or more
    Time Frame
    From baseline to 5 years
    Secondary Outcome Measure Information:
    Title
    Improved lipid profile
    Description
    Lower fasting lipid profile (triglycerides/cholesterol)
    Time Frame
    From baseline to 5 years
    Title
    Improved quality of live
    Description
    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.
    Time Frame
    From baseline to 5 years
    Title
    Blood pressure reduction
    Description
    Systolic and diastolic blood pressure
    Time Frame
    From baseline to 5 years
    Title
    Body fat percentages reduction
    Description
    Body fat percentages measured by bioelectrical impedance analysis (BIA)
    Time Frame
    From baseline to 5 years
    Title
    Urate reduction
    Description
    Lower urate level
    Time Frame
    From baseline to 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lena Lendahls, PhD
    Organizational Affiliation
    Kronoberg County Council
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sara Holmberg, MD, PhD
    Organizational Affiliation
    Kronoberg County Council
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kjell-Ake I Alle, MD, PhD
    Organizational Affiliation
    Kronoberg County Council
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mari Bergenholz-Liljedal, Nurse
    Organizational Affiliation
    Kronoberg County Council
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    17316327
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16988085
    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.
    Results Reference
    background
    PubMed Identifier
    21944718
    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.
    Results Reference
    background
    PubMed Identifier
    18362231
    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.
    Results Reference
    background
    PubMed Identifier
    22081948
    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.
    Results Reference
    background
    Links:
    URL
    http://www.folkhalsomyndigheten.se
    Description
    The Public Health Agency of Sweden (2017). National Public Health Data:overweight and adiposity.[2017-02-26]
    URL
    http://dx.doi.org/10.3402/fnr.v57i0.22903
    Description
    New Nordic Nutrition Recommendations are here. Food & Nutrition Research
    URL
    http://www.sbu.se
    Description
    Swedish Council on Health Technology Assessment.Food with adiposity: a systematic literature review (SBU report) [2013]

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

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