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

NCT ID: NCT02487251

Last Updated: 2022-01-11

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-02

Study Completion Date

2020-10-31

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental: Phase 1 Usual Exposure

Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.

Group Type EXPERIMENTAL

Usual Exposure

Intervention Type BEHAVIORAL

Participants receive no supplemental information on family mealtimes beyond what is already currently received

Experimental: Phase 1 Mealtime support activities

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).

Group Type EXPERIMENTAL

Mealtime Supports

Intervention Type BEHAVIORAL

Participants 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.

Experimental: Phase 2- Usual Exposure

Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.

Group Type EXPERIMENTAL

Usual Exposure

Intervention Type BEHAVIORAL

Participants receive no supplemental information on family mealtimes beyond what is already currently received

Experimental: Phase 2- Meal Delivery and Receipt of Cookware

Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware

Group Type EXPERIMENTAL

Mealtime Supports

Intervention Type BEHAVIORAL

Participants 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.

Interventions

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Mealtime Supports

Participants 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.

Intervention Type BEHAVIORAL

Usual Exposure

Participants receive no supplemental information on family mealtimes beyond what is already currently received

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Holly Brophy-Herb

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Holly E. Brophy-Herb, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Michigan State University

East Lansing, Michigan, United States

Site Status

Jackson Community Action Agency Head Start

Jackson, Michigan, United States

Site Status

Capital Are Community Services Head Start

Lansing, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35337884 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28187722 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2015-68001-23239

Identifier Type: -

Identifier Source: org_study_id

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