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

NCT ID: NCT03861754

Last Updated: 2019-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-28

Study Completion Date

2010-05-31

Brief Summary

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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)

Detailed Description

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Conditions

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Obesity Weight Loss Physical Activity Healthy Obesity, Metabolically

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle modification

intensified Behavioural Modification (iBM) group receiving lifestyle counselling

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

Control Group

Control group, no intervention, only measurements and questionnaires

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle modification

Intervention Type BEHAVIORAL

Other Intervention Names

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Lifestyle modification and exercise 1 Lifestyle modification and exercise 2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu Deaconess Institute Foundation sr

UNKNOWN

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Kaisu Kaikkonen

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu Deaconess Institute Foundation sr

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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147/2006

Identifier Type: -

Identifier Source: org_study_id

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