A FAMILY Program for Childhood Overweight and Obesity
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|ClinicalTrials.gov Identifier: NCT03773250|
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Behavioral intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A FAMILY Program for Childhood Overweight and Obesity|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Behavioral Intervention
Children and families in the intervention group will received the FAMILY program developed according to evidence-based guidelines.The intervention content regarding healthy sleep will emphasize the importance of having a consistent sleep schedule, establishing a regular bedtime routine, and creating an environment only for sleeping. The physical activity content will emphasize at least 60 minutes/day of moderate-to-vigorous intensity physical activity, reduction of sedentary behavior, and screen time limited to 2 hours/day. The nutrition content will emphasis the replacement of sugar-sweetened beverages, increased fruit and vegetable as well as water intake, consumption of regular meals, and reduction of discretionary food groups.
Behavioral: Behavioral intervention
The intervention has an intensive phase and a maintenance phase.
No Intervention: Control
No intervention will be provided.
- Body mass index [ Time Frame: Change from baseline to 6 months post intervention ]Body mass index will be calculated using children's height and weight.
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): NCT03773250
|Contact: Shao-Yu Tsai, PhD||+886-23123456 ext firstname.lastname@example.org|
|Contact: Ching-Chia Hsieh, BS|
|National Taiwan University||Recruiting|
|Contact: Shao-Yu Tsai, PhD|
|Principal Investigator:||Shao-Yu Tsai, PhD||National Taiwan University|