Viewing Study NCT06548074



Ignite Creation Date: 2024-10-25 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06548074
Status: ENROLLING_BY_INVITATION
Last Update Posted: None
First Post: 2024-07-26

Brief Title: H-PACE Program for the Improvement of Lifestyle Behaviors Among Children
Sponsor: None
Organization: None

Study Overview

Official Title: Multicenter Pilot Project to Test the Healthy Parents and Children Enhancement H-PACE Program
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement H-PACE program for improving lifestyle behaviors among children Proper nutrition and physical activity PA are essential parts of overall health Together they can decrease the risk of developing obesity as well as related diseases such as diabetes heart disease stroke and several types of cancer To address the prevalence of obesity and related diseases programs focusing on increasing opportunities for active living and healthy eating are necessary Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits however most afterschool programs are short term evidence is needed to confirm long-term effects Moreover programs that involve parents have shown to be more successful in helping children choose healthier behaviors Unfortunately due to technological advancement opportunities for children to be active in schools have become more limited in modern society H-PACE program is based on the national childhood obesity prevention campaign designed to help families schools communities and physicians to raise awareness of nutritional and PA daily guidelines The H-PACE will encourage daily lifestyle behaviors five or more servings of fruits and vegetables two hours or less of recreational screen time one hour of PA zero sugary drinks ten hours of sleep that impact childhood obesity This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children
Detailed Description: OUTLINE

Children attend the H-PACE program comprising educational lessons over 30 minutes PA over 30 minutes and healthy snacks twice a week BIW for 12 weeks The educational component includes 30-minute lessons on PA fruits and vegetables and sleep followed by fun and entertaining games and activities The PA component 30-minutes comprises a variety of enjoyable activities including warm-up main activities eg walkrunjog and aerobic fun games and cool-down The snack component introduces children to tasty and healthy foods and teaches children the skills to enable them to select and prepare healthy snack foods at school and at home Snack education lessons emphasize the benefits of fruit and vegetable intake and include a discussion of food composition eg fat content sugar sodium Children prepare healthy snack foods at home with parents once a week QW by taking home fruit and vegetable boxes with recipes for family-based engaging activities Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12 Parents may participate in an optional virtual peer support group on study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None