Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/10/2007
Date assigned
06/03/2008
Last edited
16/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Petra Warschburger

ORCID ID

Contact details

University of Potsdam
Department of Psychology
Karl-Liebknecht-Str. 24-25
Potsdam OT Golm
14476
Germany
+49 (0)331 9772874
warschb@uni-potsdam.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WA 1143 / 4-2

Study information

Scientific title

Empowering Parents of Obese Children: development and controlled evaluation of an obesity-specific parenting skills training

Acronym

EPOC

Study hypothesis

A compact parent training enhancing "obesity-specific" parenting skills combined with written information and a training video contemporaneous with the inpatient training of the children leads to a greater reduction of percentage overweight (BMI-SDS) in the obese children and an improvement of children and parents' psychosocial variables one year after the end of intervention compared to a parent group only receiving written information.

Ethics approval

Ethics Committee of the University of Potsdam, 19/05/2006

Study design

Prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Obesity

Intervention

Parent training course (intervention group) vs written information only (control group)

Parent training course:
Key activity: Cognitive-behavioral training, focusing on how parents can support their children at home in critical behavioural tasks (increasing physical activity, dietary changes).
Materials and techniques: Group discussions, role play, work sheets, introduction of critical situations (video), take-home video and take-home written information.
The participants will be taught by health professionals of the participating clinics (psychologists, pedagogues, nutritionists, dieticians, etc.)
Duration of the course: 2 days (in most instances weekend-course), 10 sessions, on average 50 minutes per session

Topics/contents of the written information provided to the control group:
1. Etiology of obesity
2. "Traffic light" diet
3. Advice on increasing activity (physical exercise and daily motor activity)
4. Dietary changes

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

BMI-SDS in children, assessed at T1, T2, T4, T5 and T6 (assessed by a physician, an interview and a questionnaire)

Timepoints:
T1: Start of the child's inpatient stay
T2: End of the child's inpatient stay
T3 (Applicable only for the intervention group; timepoint when a telephone booster session takes place) : One month after the child's inpatient stay
T4: Three months after the child's inpatient stay
T5: Six months after the child's inpatient stay
T6: Twelve months after the child's inpatient stay

Secondary outcome measures

1. Psychosocial variables of parents:
1.1. Self-efficacy, assessed at T1, T2, T4, T5 and T6 by questionnaires and an interview
1.2. Psychosocial strain, assessed at T1 and T6 by the Short Form (SF)-12 State of Health Questionnaire
1.3. Familial support, assessed at T1, T4, T5 and T6 by questionnaires and an interview
1.4. Feeding style, assessed at T1, T4, T5 and T6 by the Child Feeding Questionnaire (CFQ), Caregiver's Feeding Styles Questionnaire (CFSQ) and an interview

2. Psychosocial variables of children:
2.1. General quality of life, assessed at T1, T4, T5 and T6 by a children's quality of life questionnaire (KINDL)
2.2. Weight-related quality of life, assessed at T1, T2, T4, T5 and T6 by a weight-related quality of life questionnaire (GW-LQ-KJ) and an interview
2.3. General self-efficacy, assessed at T1, T2, T4, T5 and T6 by questionnaires
2.4. Weight-related self-efficacy, assessed at T1, T4, T5 and T6 by a weight-related self-efficacy questionnaire (GW-SW-KJ)
2.5. Eating behaviour, assessed at T1, T4, T5 and T6 by the Eating Behaviour Questionnaire (FKE-KJ)
2.6. Activity behaviour, assessed at T1, T4, T5 and T6 by the German Health Interview and Examination Survey for Children and Adolescents questionnaire
2.4. Familial support, assessed at T1, T4, T5 and T6 by a questionnaire
2.5. Psychosocial strain, assessed at T1 and T6 by the Strengths & Difficulties Questionnaire (SDQ)

Timepoints:
T1: Start of the child's inpatient stay
T2: End of the child's inpatient stay
T3 (Applicable only for the intervention group; timepoint when a telephone booster session takes place): One month after the child's inpatient stay
T4: Three months after the child's inpatient stay
T5: Six months after the child's inpatient stay
T6: Twelve months after the child's inpatient stay

Overall trial start date

01/04/2007

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criterria as of 16/05/2012:
1. Children aged 7-13 years
2. Duration of inpatient stay at least four weeks
3. BMI-SDS exceeding the 97th percentile
4. Informed consent to participate in the study and to participate in the parent training if randomised into the intervention group

Previous inclusion criteria:
1. Children aged 7-12 years
2. Duration of inpatient stay at least four weeks
3. BMI-SDS exceeding the 97th percentile
4. Informed consent to participate in the study and to participate in the parent training if randomised into the intervention group

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Inadequate German language skills of the parent
2. Secondary obesity as a consequence of other diseases
3. Major comorbid diseases
4. Major behavioural or psychiatric disorder of the child
5. Psychiatric disorder of the parent
6. Previous or concomitant parent training by other sources or accompaniment by the parent during the child's inpatient stay

Recruitment start date

01/04/2007

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University of Potsdam
Potsdam OT Golm
14476
Germany

Sponsor information

Organisation

German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53175
Germany
+49 (0)228 8851
postmaster@dfg.de

Sponsor type

Government

Website

http://www.dfg.de

Funders

Funder type

Government

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27074374
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27842526

Publication citations

Additional files

Editorial Notes

16/11/2016: Publication references added. 16/05/2012: the overall trial end date was changed from 31/03/2010 to 31/12/2012.