A Group-based Treatment of Overweight and Obesity in Primary Care

NCT03914066 | Terminated

• 1 other identifier: 267621
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Overweight and obesity is a growing problem in the world. Today more than 50 % of all people over 18 years in Sweden are overweight or obese. Main reasons for this are changes in lifestyle habits regarding diet and physical exercise. Overweight and obesity increases risk of different diseases such as type 2 diabetes, arthrosis and cancer; it also affects quality of life. Losing 5-10 % of your body weight improves metabolic health and quality of life. Lifestyle changes are very important in order to lose weight but it can be challenging to carry through with these changes on your own without support. In the primary care in Region Orebro län a group treatment, "Step by step", has been in use since 2010. It comprises of six group sessions over 6-8 months with different themes such as diet, physical exercise and stress. Between the group sessions there are home assignments, such as writing a diet or exercise diary. This observational study will evaluate "Step by step" and the effect the group treatment has on the participants' weight, dietary habits, physical activity, quality of life, eating habits and metabolic health.

Conditions

Overweight and Obesity

Keywords

overweight; obesity; group treatment; primary care

Outcome Measures

Primary Outcomes (1)

• Weight reduction in kg and % from baseline to 6-8 months and 12 months.

  Measured in kilograms

  Change from baseline to follow-up at 6-8 months and 12 months.

Secondary Outcomes (9)

• Change in Dietary habits

  Change from baseline to follow-up at 6-8 months and 12 months.

• Change in Physical activity

  Change from baseline to follow-up at 6-8 months and 12 months.

• Change in general Health-related Quality of Life

  Change from baseline to follow-up at 6-8 months and 12 months.

• Change in Obesity-specific Health-related Quality of Life

  Change from baseline to follow-up at 6-8 months and 12 months.

• Change in Eating patterns

  Change from baseline to follow-up at 6-8 months and 12 months.

Study Arms (1)

Group treatment in primary care

EXPERIMENTAL

The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.

Behavioral: A group-based treatment of overweight and obesity

Interventions

A group-based treatment of overweight and obesity BEHAVIORAL

The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.

Group treatment in primary care

Eligibility Criteria

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

You may qualify if:

• years and older
• BMI 30 or over
• BMI over 28 and under 30 with one or more of following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnoea or polycystic ovary syndrome.

You may not qualify if:

• Severe mental illness
• Previous or present eating disorder
• Pregnancy
• Breast feeding
• Serious cancer under treatment
• Use of weight-loss drugs
• Misuse of alcohol or drugs
• Type 1 diabetes
• Not being able to speak/read/write Swedish.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Region Orebro lan

Örebro, Sweden

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Officials

• Agneta Anderzén Carlsson, RN, Assoc. P

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: September 3, 2019
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: May 10, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)