NCT03861754

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2004

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

6.3 years

First QC Date

February 26, 2019

Last Update Submit

February 28, 2019

Conditions

ObesityWeight LossPhysical ActivityHealthy Obesity, Metabolically

Keywords

ObesityWeight lossWeight maintenancePhysical activityFitness

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Kilograms

    Change from baseline weight at 36 months

Secondary Outcomes (1)

  • Waist circumference change

    Change from baseline waist circumference at 36 months

Study Arms (4)

Lifestyle modification

EXPERIMENTAL

intensified Behavioural Modification (iBM) group receiving lifestyle counselling

Behavioral: Lifestyle modification

Lifestyle modification and exercise 1

EXPERIMENTAL

Intensified Behavioural Modification and exercise from 0 to 3 months (CWT1) group: Lifestyle counselling 3 months Exercise intervention from 0 to 3 months

Behavioral: Lifestyle modification

Lifestyle modification and exercise 2

EXPERIMENTAL

Intensified Behavioural Modification and exercise from 6 to 9 months (CWT2) group: Lifestyle counselling 3 months Exercise intervention from 6 to 9 months

Behavioral: Lifestyle modification

Control Group

NO INTERVENTION

Control group, no intervention, only measurements and questionnaires

Interventions

Lifestyle modificationBEHAVIORAL
Also known as: Lifestyle modification and exercise 1, Lifestyle modification and exercise 2
Lifestyle modificationLifestyle modification and exercise 1Lifestyle modification and exercise 2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass Index \> 30
  • Age 18-64

You may not qualify if:

  • Pregnancy
  • Health reasons preventing exercise and exercise test
  • Medication preventing exercise and exercise test
  • Previously diagnosed diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu Deaconess Institute Foundation sr

Oulu, 90100, Finland

Location

MeSH Terms

Conditions

ObesityWeight LossMotor ActivityObesity, Metabolically Benign

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 4, 2019

Study Start

January 28, 2004

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 4, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)