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Completed

NCT Number: NCT03861754

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

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)

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu Deaconess Institute Foundation sr

Oulu, 90100, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Modification

Behavioral

Other names: Lifestyle modification and exercise 1, Lifestyle modification and exercise 2

Primary outcomes

  1. Weight change

    Time frame: Change from baseline weight at 36 months

    Kilograms

Secondary outcomes

  1. Waist circumference change

    Time frame: Change from baseline waist circumference at 36 months

    Cm

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu Deaconess Institute Foundation sr
  • Oulu University Hospital

Registry information

Acronym: LILA

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 4, 2019
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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