Get-a-Grip Lifestyle Management Programme

NCT04003259 | Completed

• 1 other identifier: R12099
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity; Hypertension; Dyslipidemias; Diabetes

Keywords

Diet; Exercise; Lifestyle; Weight control

Outcome Measures

Primary Outcomes (5)

• Change in weight (kg)

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

  baseline, and months 2-3, 5-6, and 11-12

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

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

  baseline, and months 2-3, 5-6, and 11-12

• Change in waist circumference (cm)

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

  baseline, and months 2-3, 5-6, and 11-12

• Change in muscle mass and body fat (percentage points)

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

  baseline, and months 2-3, 5-6, and 11-12

• Change in systolic and diastolic blood pressure (mmHg)

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

  baseline, and months 2-3, 5-6, and 11-12

Secondary Outcomes (1)

• Fitness index

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

Study Arms (1)

Overweight and obese subjects

EXPERIMENTAL

1-year lifestyle programme

Behavioral: Lifestyle management programme

Interventions

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.

Overweight and obese subjects

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University: lead
• Tampere University Hospital: collaborator
• Sitra, the Finnish Innovation Fund: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, Southern Finland, 33521, Finland

Location

Related Publications (1)

• Taurio J, Jarvinen J, Hautaniemi EJ, Eraranta A, Viitala J, Nordhausen K, Kaukinen K, Mustonen J, Porsti IH. Team-based "Get-a-Grip" lifestyle management programme in the treatment of obesity. Prev Med Rep. 2020 May 13;19:101119. doi: 10.1016/j.pmedr.2020.101119. eCollection 2020 Sep.

  PMID: 32461881 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Hypertension; Dyslipidemias; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Behavior

Study Officials

• Ilkka Pörsti, MD, PhD

  Tampere University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 1, 2019
• Study Start: January 1, 2009
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)