- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487251
Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools (SimplyDinner)
Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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East Lansing, Michigan, United States, 48824
- Michigan State University
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Jackson, Michigan, United States, 49201
- Jackson Community Action Agency Head Start
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Lansing, Michigan, United States, 48912
- Capital Are Community Services Head Start
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
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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.
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Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Holly E. Brophy-Herb, Ph.D., Michigan State University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-68001-23239
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