Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT02487251
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2015-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools
Sponsor:
Michigan State University
Organization:
Study Overview
Official Title:
Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SimplyDinner
Brief Summary:
Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.
Detailed Description:
This study is comprised of two phases. In the first phase of the study, we will test associations between participation in combinations of 6 intervention components reflecting differing levels of practical resources to increase the frequency of healthy family mealtimes, improve children's dietary quality and ultimately reduce childhood obesity prevalence. Phase 1 utilizes the Multiphase Optimization Strategy (MOST) design to test combinations of the 6 intervention components which include: (1) Meal Delivery: the home delivery of pre-made healthy family meals including recipes weekly (2) Ingredient Delivery: the home delivery of ingredients and recipes to make healthy family meals weekly; (3) Community Kitchen: community kitchen sessions in which families prepare healthy meals with recipes to take home weekly; (4) Didactics: nutrition education classes using the Preschool Obesity Prevention Series (POPS) curriculum (5) Cooking Lessons: cooking lessons/demonstrations with recipes weekly; and (6) Cookware/Flatware: delivery of flatware/ cookware to utilize for family meals delivered at the beginning of the intervention. The goal of Phase 1 is to identify the intervention components most robustly related to decreased BMI z-score, increased dietary quality and frequency of family meals. Phase 1 will enroll approximately 500 parents of preschoolers. The goal of Phase 2 is to test the selected intervention components (identified in Phase 1) in a randomized controlled trial with approximately 250 participants. Participants in both phases will be enrolled through Head Start programs and/or university research recruitment platforms, social media, and posted flyers. The intervention period in Phase 1 will be 8 weeks, and the intervention period in Phase 2 will be expanded to 12 weeks.
Study Oversight
Has Oversight DMC:
False
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?: