NCT01606904

Brief Summary

The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and follow how they benefit from the program in order to achieve maintained weight loss. Also, the associations between weight loss, physical activity and musculoskeletal disorders are studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

May 21, 2012

Last Update Submit

May 4, 2018

Conditions

ObesityHypercholesterolemiaDiabetes Mellitus, Type 2Anhedonia

Outcome Measures

Primary Outcomes (1)

  • change in weight

    kilograms

    baseline, 9 months, 1,2 and 3 years

Secondary Outcomes (4)

  • change in eating behavior

    baseline, 9 months, 1,2 and 3 years

  • change in total cholesterol,HDL, LDL,Trigly and glucose

    baseline, 1,2 and 3 years

  • DNA

    baseline

  • change in incretins

    baseline, 12, 24 and 36 months

Study Arms (2)

Weight loss counseling

EXPERIMENTAL

Cognitive behavioral therapy - based weight loss program

Behavioral: Cognitive behavioral therapy -based weight loss program

Control

OTHER

Short term weight loss counseling, control group

Behavioral: Cognitive behavioral therapy -based weight loss program

Interventions

Cognitive behavioral therapy -based weight loss programBEHAVIORAL

CBT-based program includes 20 group visits

ControlWeight loss counseling

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 30

You may not qualify if:

  • other concurrent weight loss programs
  • disease which prevents weight loss
  • medication which affects on weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment of Internal Medicine, Oulu University Hospital

Oulu, Finland

Location

Related Publications (3)

  • Keranen AM, Savolainen MJ, Reponen AH, Kujari ML, Lindeman SM, Bloigu RS, Laitinen JH. The effect of eating behavior on weight loss and maintenance during a lifestyle intervention. Prev Med. 2009 Aug;49(1):32-8. doi: 10.1016/j.ypmed.2009.04.011. Epub 2009 May 4.

    PMID: 19406146BACKGROUND

  • Keranen AM, Strengell K, Savolainen MJ, Laitinen JH. Effect of weight loss intervention on the association between eating behaviour measured by TFEQ-18 and dietary intake in adults. Appetite. 2011 Feb;56(1):156-62. doi: 10.1016/j.appet.2010.10.004. Epub 2010 Oct 16.

    PMID: 20955744BACKGROUND

  • Keranen AM, Rasinaho E, Hakko H, Savolainen M, Lindeman S. Eating behavior in obese and overweight persons with and without anhedonia. Appetite. 2010 Dec;55(3):726-9. doi: 10.1016/j.appet.2010.08.012. Epub 2010 Aug 27.

    PMID: 20801180BACKGROUND

MeSH Terms

Conditions

ObesityHypercholesterolemiaDiabetes Mellitus, Type 2Anhedonia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Study Officials

  • Anna-Maria Teeriniemi (nee Keränen)

    Oulun University Hospital

    PRINCIPAL INVESTIGATOR

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
P.h.D, clinical nutritionist

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 28, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

FI(1)