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Completed

NCT Number: NCT04003259

Get-a-Grip Lifestyle Management Programme

The primary aim of this study was to examine weight reduction in primary care in obese or overweight subjects with a comorbidity that would benefit from weight loss during 1-year comprehensive lifestyle management programme including medical examinations, personalized dietary and exercise advice, guidance on shopping behaviour and food preparation, and group discussions.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, Southern Finland, 33521, Finland

About this study

Obesity is associated with altered glucose and lipid metabolism, and elevated blood pressure (BP) increasing the risk of cardiovascular morbidity and mortality. Obesity-induced complications are increasingly encountered in the health care system and especially in primary care. Thus, there is a growing need for individually tailored weight management programs aiming to permanent lifestyle and dietary changes for the prevention and treatment of obesity-related health hazards.

The study investigated weight reduction during 1-year comprehensive lifestyle programme in 134 obese or overweight subjects (BMI>30, or BMI>25 with a comorbidity including diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea). The participants were recruited from the local diabetes centre and health care providers. The programme aimed at 5-10 % weight reduction utilizing exercise program supervised by personal trainer, advice on diet and on-location shopping behavior by a registered dietician, hands-on cooking classes by a professional chef, examinations by a medical doctor, and group discussions. The efficacy of the program was followed by measuring change in weight, BMI, waist circumference, fat and muscle percentage, visceral fat, and systolic and diastolic BP.

The study protocol has been approved by the ethics committee of the Pirkanmaa Hospital District (R12099).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI >30
  • BMI>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea)

Exclusion criteria

  • physical condition that prevented exercise
  • abuse of alcohol or drugs
  • medical history suggesting poor adherence
  • severe concurrent disease
  • moderate to severe dementia

Treatment and study plan

Lifestyle management programme

Behavioral

The programme consisted of 1) the initiation phase (1-3 months), 2) the establishment phase (3-6 months), and 3) the maintenance phase (7-12 months). Guidance was given altogether on 25 separate occasions with special emphasis on the motivation and education. The goal for weight loss was 5-10 %. The programme included four visits by medical doctor, an educational lecture by medical doctor and personal trainer, five sessions by registered dietician, two cooking classes by professional chef, two group discussions, and exercise as follows: personalized exercise program tailored by personal trainer, one-year gym access with four guided group sessions, and two guided group Nordic walking sessions, and three individual exercise sessions by personal trainer.

Primary outcomes

  1. Change in weight (kg)

    Time frame: baseline, and months 2-3, 5-6, and 11-12

    Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  2. Change in body mass index (BMI) (kg/m^2)

    Time frame: baseline, and months 2-3, 5-6, and 11-12

    BMI was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  3. Change in waist circumference (cm)

    Time frame: baseline, and months 2-3, 5-6, and 11-12

    Waist circumference was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  4. Change in muscle mass and body fat (percentage points)

    Time frame: baseline, and months 2-3, 5-6, and 11-12

    Muscle and fat percentage were measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  5. Change in systolic and diastolic blood pressure (mmHg)

    Time frame: baseline, and months 2-3, 5-6, and 11-12

    Blood pressure was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

Secondary outcomes

  1. Fitness index

    Time frame: All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12

    Fitness index was constructed from a two-kilometer walk test with heart rate monitoring and took into consideration age, gender, height, weight, walking time, and heart rate.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Sitra, the Finnish Innovation Fund
  • Tampere University Hospital

Registry information

Official study title

Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2019
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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