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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
810

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Usual Exposure
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).
Behavioral: 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.
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.
Behavioral: Usual Exposure
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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michigan State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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