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

February 28, 2019 updated by: Kaisu Kaikkonen, University of Oulu

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90100
        • Oulu Deaconess Institute Foundation sr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lifestyle modification
intensified Behavioural Modification (iBM) group receiving lifestyle counselling
Behavioral: Lifestyle modification
Other Names:
  • Lifestyle modification and exercise 1
  • Lifestyle modification and exercise 2
EXPERIMENTAL: Lifestyle modification and exercise 1

Intensified Behavioural Modification and exercise from 0 to 3 months (CWT1) group:

Lifestyle counselling 3 months Exercise intervention from 0 to 3 months
Behavioral: Lifestyle modification
Other Names:
  • Lifestyle modification and exercise 1
  • Lifestyle modification and exercise 2
EXPERIMENTAL: Lifestyle modification and exercise 2

Intensified Behavioural Modification and exercise from 6 to 9 months (CWT2) group:

Lifestyle counselling 3 months Exercise intervention from 6 to 9 months
Behavioral: Lifestyle modification
Other Names:
  • Lifestyle modification and exercise 1
  • Lifestyle modification and exercise 2
NO_INTERVENTION: Control Group
Control group, no intervention, only measurements and questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: Change from baseline weight at 36 months
Kilograms
Change from baseline weight at 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference change
Time Frame: Change from baseline waist circumference at 36 months
Cm
Change from baseline waist circumference at 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Oulu University Hospital
Oulu Deaconess Institute Foundation sr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2004

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (ACTUAL)

March 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147/2006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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