A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02021786|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Mobile phone based intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Mobile phone based intervention
The intervention in the present study is a web- and mobile phone based intervention aiming to develop healthy lifestyle behaviors regarding physical activity and dietary habits in 4-year-olds. The intervention will be delivered to the parents and it is available to the parents during six months.
Behavioral: Mobile phone based intervention
Parents in the intervention group receive a six month mHealth program (the MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet and physical activity behaviors. The program includes information, advice, and strategies to change unhealty behaviours and the possibility to register the child's intake of fruits, vegetables, candy, sweetened beverages, moderate-to-vigorous physical activity, and sedentary time. Feedback is then provided on reported variables. In addition, the parents are able to ask questions through the app to a dietician and a psychologist.
No Intervention: Control
The control group receive a pamphlet on healthy eating and physical activity in pre-school children based on the existing guidelines. The information is similar to what parents receive from the Swedish child healthcare system
- Body fat [ Time Frame: At the end of the intervention and at a six month follow-up ]Fat mass index, FMI
- Diet and physical activity variables [ Time Frame: At the end of the intervention and at a six month follow-up ]Fruit, vegetables, candy, sweetened beverages, sedentary time and physical activity
- Composite scores [ Time Frame: At the end of the intervention and at a six month follow-up ]Two scores based on the primary and secondary outcomes. The first one contains all seven outcomes (body composition, dietary variables, and physical activity variables), while the second one only includes the six secondary outcomes (dietary and physical activity variables).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021786
|Department of Biosciences and Nutrition, Karolinska Institute|
|Huddinge, Sweden, 14183|
|Principal Investigator:||Marie Lof, PhD||Karolinska Institutet|