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

November 12, 2021 updated by: Holly Brophy-Herb, Michigan State University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

810

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
      • Jackson, Michigan, United States, 49201
        • Jackson Community Action Agency Head Start
      • Lansing, Michigan, United States, 48912
        • Capital Are Community Services Head Start

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Participants receive no supplemental information on family mealtimes beyond what is already currently received
Experimental: 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).
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: 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.
Participants receive no supplemental information on family mealtimes beyond what is already currently received
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMIz
Time Frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

Research staff measured children without shoes or heavy clothing. Measures were taken twice and averaged. BMI was calculated and child BMIz derived. Child obesity was defined as BMI > 95th percentile and overweight/obesity defined as a BMI > 85th percentile for age and sex. Note that due to the COVID-19 pandemic, data on BMIz were not collected beginning in March 2020.

The z-score is based on United States Centers for Disease Control growth references for children. A z-score of 0 reflects the 50th percentile based on the US CDC children's reference growth charts. A z-score < -1.645 indicates that the child is underweight. A healthy BMIz score is between -1.645 and 1.036. BMIz >1.036 = criteria for overweight; BMIz >1.645 = criteria for obese

Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dietary Quality-Observed Fruit
Time Frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Report of the child's usual eating habits (fruit) using the Pennington Remote Food Photography method. When using the RFPM and SmartIntake app, parents place a reference card next to the child's food and capture images of the food selection and plate waste. The parent identifies foods that are not easily identified by wrappers or containers by typing a food description into a text box. These data and food images are automatically sent by the app to the server-based Food Photography Application©, which is used to manage the data collection process and analyze the food images to estimate energy and nutrient intake. First, the foods in the images were linked to a match from the United States Department of Agriculture's Food and Nutrient Database for Dietary Studies (FNDDS; USDA, 2018). Second, a standard portion image, which contains an image of the same or a similar food that was carefully weighed to represent various portion sizes, was identified from an archived food image database.
Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Change in Dietary Quality- Observed Vegetables
Time Frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Report of the child's usual eating habits (fruit) using the Pennington Remote Food Photography Method
Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Change in Dietary Quality-Parent Reported Fruit Intake
Time Frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Report of the child's usual eating habits using the Block Kids 2004 Food Frequency. Parents self-reported their children's dietary intake using the Block Dietary Data Systems Kids Food Screener-Last Week (BKFS, Version 2), a 41-item survey assessing nutrients and food groups in children aged 2-17 years (Hunsberger et al., 2015). Nutrients and food groups are reported from multiple items summed from each survey construct. The current study operationalized dietary quality in cup equivalent as reflecting the following food groupings as indicators of higher quality dietary patterns (Haya et al., 2013): fruit/fruit juice
Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Change in Dietary Quality-Parent Reported Vegetables
Time Frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Parents self-reported their children's dietary intake using the Block Dietary Data Systems Kids Food Screener-Last Week (BKFS, Version 2), a 41-item survey assessing nutrients and food groups in children aged 2-17 years (Hunsberger et al., 2015). Nutrients and food groups are reported from multiple items summed from each survey construct. The current study operationalized dietary quality in cup equivalent as reflecting the following food groupings as indicators of higher quality dietary patterns (Haya et al., 2013): vegetables excluding potatoes and legumes.
Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Change in Frequency of Healthy Family Mealtimes
Time Frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Using a 1-item question, parents reported how many nights in the week the parent and focus child are dinner together in the same place at home (e.g., in the kitchen) at the same time for most of the meal.
Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Holly E. Brophy-Herb, Ph.D., Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2015

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

June 13, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-68001-23239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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