Obesity Clinical Trial
— LILAOfficial title:
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
NCT number | NCT03861754 |
Other study ID # | 147/2006 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 28, 2004 |
Est. completion date | May 2010 |
Verified date | February 2019 |
Source | University of Oulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 120 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Oulu Deaconess Institute Foundation sr | Oulu |
Lead Sponsor | Collaborator |
---|---|
University of Oulu | Oulu Deaconess Institute Foundation sr, Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight change | Kilograms | Change from baseline weight at 36 months | |
Secondary | Waist circumference change | Cm | Change from baseline waist circumference at 36 months |
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