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

Michigan State University logo

Michigan State University

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Mealtime Supports
Behavioral: Usual Exposure

Study type

Interventional

Funder types

Other

Identifiers

NCT02487251
2015-68001-23239

Details and patient eligibility

About

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.

Full 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.

Enrollment

810 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Preschool aged child

Exclusion criteria

  • Significant feeding/eating disorders that would preclude participation in the interventions
  • Child is a foster child
  • Parent is non-English speaking

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

810 participants in 4 patient groups

Experimental: Phase 1 Usual Exposure
Experimental group
Description:
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Treatment:
Behavioral: Usual Exposure
Experimental: Phase 1 Mealtime support activities
Experimental group
Description:
Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals).
Treatment:
Behavioral: Mealtime Supports
Experimental: Phase 2- Usual Exposure
Experimental group
Description:
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Treatment:
Behavioral: Usual Exposure
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
Experimental group
Description:
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
Treatment:
Behavioral: Mealtime Supports

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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