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

Overview

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)

Full Title of Study: “Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults – Three Year Follow-up Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2010

Interventions

  • Behavioral: Lifestyle modification

Arms, Groups and Cohorts

  • Experimental: Lifestyle modification
    • intensified Behavioural Modification (iBM) group receiving lifestyle counselling
  • 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
  • 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
  • No Intervention: Control Group
    • Control group, no intervention, only measurements and questionnaires

Clinical Trial Outcome Measures

Primary Measures

  • Weight change
    • Time Frame: Change from baseline weight at 36 months
    • Kilograms

Secondary Measures

  • Waist circumference change
    • Time Frame: Change from baseline waist circumference at 36 months
    • Cm

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oulu
  • Collaborator
    • Oulu Deaconess Institute Foundation sr
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kaisu Kaikkonen, Researcher – University of Oulu

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