Clinical trial NCT02487251: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools
Official title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Family Mealtimes
Prevention
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2015-07-01
Enrollment: 810
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BMIz
timeFrame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Secondary outcomes:
measure: Change in Dietary Quality-Observed Fruit
timeFrame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
measure: Change in Dietary Quality- Observed Vegetables
timeFrame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
measure: Change in Dietary Quality-Parent Reported Fruit Intake
timeFrame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
measure: Change in Dietary Quality-Parent Reported Vegetables
timeFrame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
measure: Change in Frequency of Healthy Family Mealtimes
timeFrame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Jackson
country: United States
facility: Jackson Community Action Agency Head Start
state: Michigan
city: Lansing
country: United States
facility: Capital Are Community Services Head Start
state: Michigan
Study officials:
affiliation: Michigan State University
name: Holly E. Brophy-Herb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerver JM, Brophy-Herb HE, Sturza J, Horodynski MA, Contreras DA, Stein M, Garner E, Hebert S, Williams JM, Kaciroti N, Martoccio T, Van Egeren LA, Choi H, Martin CK, Mitchell K, Dalimonte-Merckling D, Jeanpierre LA, Robinson CA, Lumeng JC. Supporting family meal frequency: Screening Phase results from the Simply Dinner Study. Appetite. 2022 Jul 1;174:106009. doi: 10.1016/j.appet.2022.106009. Epub 2022 Mar 22.
citation: Brophy-Herb HE, Horodynski M, Contreras D, Kerver J, Kaciroti N, Stein M, Lee HJ, Motz B, Hebert S, Prine E, Gardiner C, Van Egeren LA, Lumeng JC. Effectiveness of differing levels of support for family meals on obesity prevention among head start preschoolers: the simply dinner study. BMC Public Health. 2017 Feb 10;17(1):184. doi: 10.1186/s12889-017-4074-5.