NCT01606917

Brief Summary

The purpose of this study is to examine the effects of a weight reduction program in adults, seen in a primary care setting, with overweight/obesity perceived as a health problem or with diseases related to overweight/obesity and ambitions to achieve weight reduction as part of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

6.7 years

First QC Date

May 24, 2012

Last Update Submit

May 25, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who achieved target weight at two years

    2 years

Secondary Outcomes (1)

  • Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.

    5 years

Study Arms (2)

Intensive lifestyle counseling

EXPERIMENTAL

Both dietary advice and individualized advice on increased regular physical activity.

Other: Intensive lifestyle counseling

Usual care

NO INTERVENTION

Usual care

Interventions

Both dietary advice and individualized advice on increased regular physical activity

Intensive lifestyle counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients between 18 and 70 years of age who consulted or were in care for overweight/obesity with or without type 2 diabetes
  • Hypertension, CVD
  • Coronary heart disease (CHD)
  • Dyslipidemia
  • Gallstone or musculoskeletal disorders

You may not qualify if:

  • Patients were not eligible if they were already taking part in another weight control program
  • Understood the Swedish language poorly
  • Were mentally ill or had an alcohol or drug addiction.
  • Nor were they eligible if they had a physical disability preventing intensified physical activity or were pregnant at study start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orebro County Council

Örebro, 70116, Sweden

Location

Related Publications (1)

  • Jansson SP, Engfeldt P, Magnuson A, Pt GL, Liljegren G. Interventions for lifestyle changes to promote weight reduction, a randomized controlled trial in primary health care. BMC Res Notes. 2013 May 27;6:213. doi: 10.1186/1756-0500-6-213.

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan P.O Jansson, MD PhD student

    Family Medicine Research Centre, Örebro County Council, School of Health and Medical Sciences, Örebro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Student

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

October 1, 2004

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations