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

Sponsor
University of Oulu (Other)
Overall Status
Completed
CT.gov ID
NCT03861754
Collaborator
Oulu Deaconess Institute Foundation sr (Other), Oulu University Hospital (Other)
120
Enrollment
1
Location
4
Arms
75.1
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle modification
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
Actual Study Start Date :
Jan 28, 2004
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Weight change [Change from baseline weight at 36 months]

      Kilograms

    Secondary Outcome Measures

    1. Waist circumference change [Change from baseline waist circumference at 36 months]

      Cm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oulu Deaconess Institute Foundation sr Oulu Finland 90100

    Sponsors and Collaborators

    • University of Oulu
    • Oulu Deaconess Institute Foundation sr
    • Oulu University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaisu Kaikkonen, Researcher, University of Oulu
    ClinicalTrials.gov Identifier:
    NCT03861754
    Other Study ID Numbers:
    • 147/2006
    First Posted:
    Mar 4, 2019
    Last Update Posted:
    Mar 4, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaisu Kaikkonen, Researcher, University of Oulu
    Obesity
    Weight loss
    Weight maintenance
    Physical activity
    Fitness
    Additional relevant MeSH terms:
    Obesity
    Obesity, Metabolically Benign
    Body Weight
    Weight Loss

    Study Results

    No Results Posted as of Mar 4, 2019