Clinical Trials Directory

Trials / Completed

CompletedNCT02487251

Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools

Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
810 (actual)
Sponsor
Michigan State University · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMealtime SupportsParticipants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period.
BEHAVIORALUsual ExposureParticipants receive no supplemental information on family mealtimes beyond what is already currently received

Timeline

Start date
2015-09-02
Primary completion
2020-10-01
Completion
2020-10-01
First posted
2015-07-01
Last updated
2022-01-11
Results posted
2022-01-11

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02487251. Inclusion in this directory is not an endorsement.