Healthy Home Offerings Via the Mealtime Environment (HOME) Plus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01538615|
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : March 1, 2018
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment|
|Obesity||Behavioral: HOME Plus intervention|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This is a behavioral intervention. Masking is not feasible.|
|Official Title:||Healthy Home Offerings Via the Mealtime Environment (HOME) Plus|
|Study Start Date :||July 2010|
|Primary Completion Date :||July 2015|
|Study Completion Date :||June 2016|
Experimental: HOME Plus Intervention
Behavioral: HOME Plus intervention
The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
No Intervention: Control
Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.
- Change in Child Body Mass Index (BMI Z-score) [ Time Frame: Change from Baseline at 12 and 21 months ]Trained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.
- Change in Target Children's Daily Intakes of Fruits and Vegetables [ Time Frame: Change from Baseline at 12 and 21 months ]A trained interviewer will complete three 24-hour dietary recalls at each data collection time point with the child. The three days will be averaged to get an estimate of usual intake. Analyses controlled for child age and parent education at baseline.
- Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week [ Time Frame: Change from Baseline at 12 and 21 months ]Screen time will be measured with survey questions asking children how many hours per day they spend doing each sedentary activity (such as watching TV, using the computer, playing video games). Separate questions will be asked for week days and weekend days then the will be weighted to determine the hours of sedentary activity per week. Analyses controlled for child age and parent education at baseline.
- Change in Number of Fruits and Vegetables Available in the Home [ Time Frame: Change from Baseline at 12 and 21 months ]The HOME Food Inventory assesses which foods families currently have in their home from a list of items. Analyses controlled for child age and parent education.
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): NCT01538615
|United States, Minnesota|
|University of Minnesota, School of Nursing|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Jayne A Fulkerson, PhD||University of Minnesota, School of Nursing|