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van CCT (UK)

van CCT (UK)

"Samen Happie!" An mHealth intervention to prevent obesity through parenting

- candidate number28147
- NTR NumberNTR6938
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2017
- Secondary IDsECSW-2017-013 Ethical Committee Social Sciences, Radboud University, Nijmegen, the Netherlands
- Public Title"Samen Happie!" An mHealth intervention to prevent obesity through parenting
- Scientific TitleThe effectiveness of an mHealth parenting intervention to prevent childhood obesity: A randomized controlled trial
- hypothesisOverweight and childhood obesity are still serious health problems, especially among children from families with lower socio-economic status (SES). Current obesity prevention programs are often not focussed on children’s first years of life, although this is the period in which behaviour is still malleable and in which unhealthy habits become established. Hence, we developed a parenting intervention in which we stimulate healthy parenting among lower-SES parents from an early age in order to prevent obesity among young children. For the intervention, we use a mobile application through which parents can (1) learn about, and (2) actively practice with healthy parenting practices and –styles. The effectiveness of the application will be examined in a RCT with two conditions: an intervention in which parents receive the mobile application, and a wait-list control condition (these parents receive the mobile application after the study has ended). Parents in the intervention condition are expected to perform more healthy parenting practices than parents in the control condition after the 12-month intervention period. We also expect that children of parents who received the intervention have a healthier weight status (BMI) than children of parents who did not receive the intervention.
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity
- Inclusion criteriaParent-child dyads are eligible for participation when parents have a child aged 7-to-11-months old at the time of the baseline measurement. We identified this age range as a critical period for intervention onset, as it appeared from focus groups that we conducted that this is the phase in which most parents start to offer their child additional foods and drinks, alongside milk. Moreover, to parents should have a low (i.e., no education, primary school, or preporatory vocational education) or medium (i.e., vocational education) level educational attainment. We use educational attainment as a proxy for socio-economic status (SES). In total, we strive to include 60% parents with low and 40% parents with medium level SES.
- Exclusion criteriaParent-child dyads will be excluded from the study if the infant has any diagnosed congenital anomalies or a chronic condition that is likely to influence normal development (including feeding behaviour).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-okt-2019
- Target number of participants300
- InterventionsParents will be randomly assigned to either the intervention condition or the control condition. Parents in the control condition will receive a mobile application through which they can learn about specific healthy parenting practices and a general healthy authoritarian parenting style. The information will be presented through short and simple fact cards, practical tips, and quizzes. Moreover, in the app parents can actually practice healthy parenting practices and -styles through various challenges (e.g., based on implementation intentions). The information in the app is grouped into four important determinants for healthy development, namely eating, drinking, sleeping, and exercise, and adjusted to the age of the child. The textual information in the app is short, simply formulated, and visually supported. For the most important information a movie clip with a voice-over is available. Moreover, the app tries to target common barriers to healthy parenting for low-SES parents (e.g., stress and financial worries) by offering, for example, relaxation exercises and cheap, simple recipes. Parents in the control condition will receive the mobile application after the intervention period (waitlist-control condition).
- Primary outcome1. Outcome name: child antropometric characteristics (i.e., length and weight) measured via child health care centres (self-reported by parents or collected directly through, used to calculate body ass index (BMI, measured in kg/m2)
Timepoints: baseline, 6 months, 12 months (and possibly additional timepoints up to 4 years, depending on the timing of the measurements at the health care centres)
- Secondary outcome2. Outcome name: parental parenting practices with respect to child weight-related behaviours (eating, drinking, sleeping, physical activity/screen time)
Timepoints: baseline, 6 months, 12 months
3. Outcome name: weight-related behaviours of the child (including healthy eating, drinking, sleeping, and exercise)
Timepoints: baseline, 6 months, 12 months
4. Outcome name: general parenting style
Timepoints: baseline, 6 months, 12 months
5. Parental wellbeing (e.g., including depression, self-reported health, happiness)
Timepoints: baseline, 6 months, 12 months
6. Parental cognitions (e.g., including parenting related self-efficacy and motivation)
Timepoints: baseline, 6 months, 12 months
- TimepointsSee above
- Trial web
- statusplanned
- Sponsor/Initiator Behavioural Science Institute, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsKarssen, L. T., & Larsen, J. K. (2017). De rol van opvoeding in overgewicht bij kinderen uit lage sociaal-economische milieus: Tijdig ingrijpen met de Samen Happie! app. Vakblad Sociaal Werk, 18(6), 27-29.
- Brief summaryThe study will be carried out in the Netherlands.
- Main changes (audit trail)26-jan-2018: No METC approval, but approval from the Ethiek Commissie Sociale Wetenschappen of the RU
- RECORD6-nov-2017 - 26-jan-2018

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