NCT02794090

Brief Summary

This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

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, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

5.3 years

First QC Date

May 31, 2016

Last Update Submit

June 8, 2016

Conditions

Keywords

Behavioral treatmentTelephone coachingOutpatient clinic

Outcome Measures

Primary Outcomes (1)

  • Change in BMI Standard Deviation Score (units)

    BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001.

    From start of treatment, during intervention and follow-up. In total mean 3,7 years

Secondary Outcomes (2)

  • Working time required for the Health care personnel

    During the intervention 18 months

  • Families experience of the treatment

    During the intervention 18 months

Study Arms (2)

Usual care, individual visits

ACTIVE COMPARATOR

Usual care according to regular treatment routines at the clinic during 18 months. The Child and parent(s) at regular visits to the nurse at the clinic.

Behavioral: Usual care, individual visits

Telephone coaching

ACTIVE COMPARATOR

Intervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents.

Behavioral: Telephone coaching

Interventions

Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.

Usual care, individual visits

Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.

Telephone coaching

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 5 to 14 years old who were patients at the outpatient pediatric centre
  • All families after that the parents had attended at least 4 of 7 meetings in a parental/education group.

You may not qualify if:

  • Obesity related syndromes
  • Non-Swedish speaking families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pernilla Danielsson, PhD

    Karolinska Institutet

    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
PhD pediatric nurse

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 8, 2016

Study Start

May 1, 2007

Primary Completion

September 1, 2012

Study Completion

January 1, 2013

Last Updated

June 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share