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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
Deutsche Forschungsgemeinschaft
Alternative name(s)
German Research Association, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27074374
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27842526