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Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study (LILA)

Primary Purpose

Obesity, Weight Loss, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Weight maintenance, Physical activity, Fitness

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass Index > 30
  • Age 18-64

Exclusion Criteria:

  • Pregnancy
  • Health reasons preventing exercise and exercise test
  • Medication preventing exercise and exercise test
  • Previously diagnosed diabetes

Sites / Locations

  • Oulu Deaconess Institute Foundation sr

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Lifestyle modification

Lifestyle modification and exercise 1

Lifestyle modification and exercise 2

Control Group

Arm Description

intensified Behavioural Modification (iBM) group receiving lifestyle counselling

Intensified Behavioural Modification and exercise from 0 to 3 months (CWT1) group: Lifestyle counselling 3 months Exercise intervention from 0 to 3 months

Intensified Behavioural Modification and exercise from 6 to 9 months (CWT2) group: Lifestyle counselling 3 months Exercise intervention from 6 to 9 months

Control group, no intervention, only measurements and questionnaires

Outcomes

Primary Outcome Measures

Weight change
Kilograms

Secondary Outcome Measures

Waist circumference change
Cm

Full Information

First Posted
February 26, 2019
Last Updated
February 28, 2019
Sponsor
University of Oulu
Collaborators
Oulu Deaconess Institute Foundation sr, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03861754
Brief Title
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
Acronym
LILA
Official Title
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2004 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Oulu Deaconess Institute Foundation sr, Oulu University Hospital

4. Oversight

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

5. Study Description

Brief Summary
Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction. Design 36-month, 4-group parallel, randomized trial. Setting Oulu, Finland. Participants 120 obese adults (body mass index ≥ 30). Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30), behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n = 30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The intervention consisted of an intensified weight loss period (1-12 months) followed by a weight maintenance period (13-36 months). Intensified behavioural modification included 14 individual face to face meetings, eleven times with a personal therapist (qualified nurse) and three times with a nutritionist. Weight maintenance period included six individual meetings with personal therapist. Twelve weeks supervised exercise was offered three times a week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3 and in the CWT2 group at months 4-6. Measurements Body weight (primary outcome) and waist circumference (secondary outcome)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Physical Activity, Healthy Obesity, Metabolically
Keywords
Obesity, Weight loss, Weight maintenance, Physical activity, Fitness

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
intensified Behavioural Modification (iBM) group receiving lifestyle counselling
Arm Title
Lifestyle modification and exercise 1
Arm Type
Experimental
Arm Description
Intensified Behavioural Modification and exercise from 0 to 3 months (CWT1) group: Lifestyle counselling 3 months Exercise intervention from 0 to 3 months
Arm Title
Lifestyle modification and exercise 2
Arm Type
Experimental
Arm Description
Intensified Behavioural Modification and exercise from 6 to 9 months (CWT2) group: Lifestyle counselling 3 months Exercise intervention from 6 to 9 months
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group, no intervention, only measurements and questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Other Intervention Name(s)
Lifestyle modification and exercise 1, Lifestyle modification and exercise 2
Primary Outcome Measure Information:
Title
Weight change
Description
Kilograms
Time Frame
Change from baseline weight at 36 months
Secondary Outcome Measure Information:
Title
Waist circumference change
Description
Cm
Time Frame
Change from baseline waist circumference at 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass Index > 30 Age 18-64 Exclusion Criteria: Pregnancy Health reasons preventing exercise and exercise test Medication preventing exercise and exercise test Previously diagnosed diabetes
Facility Information:
Facility Name
Oulu Deaconess Institute Foundation sr
City
Oulu
ZIP/Postal Code
90100
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study

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