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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Lifestyle modification


Locations

Country Name City State
Finland Oulu Deaconess Institute Foundation sr Oulu

Sponsors (3)

Lead Sponsor Collaborator
University of Oulu Oulu Deaconess Institute Foundation sr, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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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