Trial Outcomes & Findings for Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools (NCT NCT02487251)
NCT ID: NCT02487251
Last Updated: 2022-01-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
810 participants
Primary outcome timeframe
Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Results posted on
2022-01-11
Participant Flow
Study enrollment across the study reflect the number of parent-child dyads enrolled. Data were collected from both parent and child. Baseline characteristics of child and parent age, ethnicity, and BMIz, are reported.
Participant milestones
| Measure |
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.
Usual Exposure: 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).
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: 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.
Usual Exposure: 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
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
434
|
65
|
152
|
159
|
|
Overall Study
COMPLETED
|
366
|
55
|
125
|
134
|
|
Overall Study
NOT COMPLETED
|
68
|
10
|
27
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Note that the number analyzed may differ from the total number enrolled due to missing data.
Baseline characteristics by cohort
| Measure |
Experimental: Phase 1 Usual Exposure
n=434 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 1 Mealtime Support Activities
n=65 Participants
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).
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: Phase 2- Usual Exposure
n=152 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=159 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
Total
n=810 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 6.9 • n=434 Participants
|
28.7 years
STANDARD_DEVIATION 5.6 • n=65 Participants
|
33.9 years
STANDARD_DEVIATION 5.8 • n=152 Participants
|
34.0 years
STANDARD_DEVIATION 5.8 • n=159 Participants
|
31.65 years
STANDARD_DEVIATION 2.71 • n=810 Participants
|
|
Sex: Female, Male
Female
|
416 Participants
n=434 Participants
|
59 Participants
n=65 Participants
|
139 Participants
n=152 Participants
|
147 Participants
n=159 Participants
|
761 Participants
n=810 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=434 Participants
|
6 Participants
n=65 Participants
|
13 Participants
n=152 Participants
|
12 Participants
n=159 Participants
|
49 Participants
n=810 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=434 Participants
|
5 Participants
n=65 Participants
|
15 Participants
n=152 Participants
|
14 Participants
n=159 Participants
|
70 Participants
n=810 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
398 Participants
n=434 Participants
|
60 Participants
n=65 Participants
|
136 Participants
n=152 Participants
|
144 Participants
n=159 Participants
|
738 Participants
n=810 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=434 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=152 Participants
|
1 Participants
n=159 Participants
|
2 Participants
n=810 Participants
|
|
Child BMIz
|
.64 zscore
STANDARD_DEVIATION 1.07 • n=403 Participants • Please note that the sample sizes for data differ depending on the measure. For example, some BMIz data are missing in Phase 1 if the child was not home during the data collection visit to measured and measurements could not be obtained at other settings (e.g., at school). BMIz data are also missing extensively in Phase 2 due to the COVID-19 pandemic because in person data collection was not possible.
|
.72 zscore
STANDARD_DEVIATION 1.10 • n=63 Participants • Please note that the sample sizes for data differ depending on the measure. For example, some BMIz data are missing in Phase 1 if the child was not home during the data collection visit to measured and measurements could not be obtained at other settings (e.g., at school). BMIz data are also missing extensively in Phase 2 due to the COVID-19 pandemic because in person data collection was not possible.
|
.34 zscore
STANDARD_DEVIATION 1.03 • n=114 Participants • Please note that the sample sizes for data differ depending on the measure. For example, some BMIz data are missing in Phase 1 if the child was not home during the data collection visit to measured and measurements could not be obtained at other settings (e.g., at school). BMIz data are also missing extensively in Phase 2 due to the COVID-19 pandemic because in person data collection was not possible.
|
.40 zscore
STANDARD_DEVIATION 1.04 • n=112 Participants • Please note that the sample sizes for data differ depending on the measure. For example, some BMIz data are missing in Phase 1 if the child was not home during the data collection visit to measured and measurements could not be obtained at other settings (e.g., at school). BMIz data are also missing extensively in Phase 2 due to the COVID-19 pandemic because in person data collection was not possible.
|
.56 zscore
STANDARD_DEVIATION 1.07 • n=692 Participants • Please note that the sample sizes for data differ depending on the measure. For example, some BMIz data are missing in Phase 1 if the child was not home during the data collection visit to measured and measurements could not be obtained at other settings (e.g., at school). BMIz data are also missing extensively in Phase 2 due to the COVID-19 pandemic because in person data collection was not possible.
|
|
Parent BMI
|
31.51 mean
STANDARD_DEVIATION 13.96 • n=434 Participants
|
30.44 mean
STANDARD_DEVIATION 8.50 • n=65 Participants
|
29.75 mean
STANDARD_DEVIATION 13.30 • n=152 Participants
|
29.85 mean
STANDARD_DEVIATION 8.63 • n=159 Participants
|
30.39 mean
STANDARD_DEVIATION 0.81 • n=810 Participants
|
PRIMARY outcome
Timeframe: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).Population: Preschool aged children
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
Outcome measures
| Measure |
Experimental: Phase 1 Usual Exposure
n=403 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 1 Mealtime Support Activities
n=63 Participants
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).
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: Phase 2- Usual Exposure
n=114 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=112 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
|---|---|---|---|---|
|
Change in BMIz
|
.0060 z-score
Standard Deviation .39
|
.00027 z-score
Standard Deviation .37
|
.04 z-score
Standard Deviation .44
|
-.02 z-score
Standard Deviation .38
|
SECONDARY outcome
Timeframe: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).Population: Parents of preschool aged children; note that observed dietary quality data was only collected in Phase 2.
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.
Outcome measures
| Measure |
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.
Usual Exposure: 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).
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: Phase 2- Usual Exposure
n=104 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=107 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
|---|---|---|---|---|
|
Change in Dietary Quality-Observed Fruit
|
—
|
—
|
-.03 cup equivalent
Standard Deviation .26
|
-.04 cup equivalent
Standard Deviation .27
|
SECONDARY outcome
Timeframe: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).Population: Parents of preschool aged children. Note that observed dietary quality was not included in Phase 1.
Report of the child's usual eating habits (fruit) using the Pennington Remote Food Photography Method
Outcome measures
| Measure |
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.
Usual Exposure: 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).
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: Phase 2- Usual Exposure
n=104 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=107 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
|---|---|---|---|---|
|
Change in Dietary Quality- Observed Vegetables
|
—
|
—
|
-.01 cup equivalent
Standard Deviation .13
|
.05 cup equivalent
Standard Deviation .15
|
SECONDARY outcome
Timeframe: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).Population: Parents of preschool aged children
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
Outcome measures
| Measure |
Experimental: Phase 1 Usual Exposure
n=355 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 1 Mealtime Support Activities
n=52 Participants
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).
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: Phase 2- Usual Exposure
n=125 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=125 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
|---|---|---|---|---|
|
Change in Dietary Quality-Parent Reported Fruit Intake
|
-.04 cup equivalent
Standard Deviation .86
|
.09 cup equivalent
Standard Deviation 1.01
|
-.21 cup equivalent
Standard Deviation .71
|
-.10 cup equivalent
Standard Deviation .73
|
SECONDARY outcome
Timeframe: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).Population: Parents of preschool aged children
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.
Outcome measures
| Measure |
Experimental: Phase 1 Usual Exposure
n=355 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 1 Mealtime Support Activities
n=52 Participants
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).
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: Phase 2- Usual Exposure
n=125 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=125 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
|---|---|---|---|---|
|
Change in Dietary Quality-Parent Reported Vegetables
|
-.02 cup equivalent
Standard Deviation .37
|
.04 cup equivalent
Standard Deviation .35
|
-.06 cup equivalent
Standard Deviation .30
|
-.04 cup equivalent
Standard Deviation .29
|
SECONDARY outcome
Timeframe: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).Population: Parents of preschool aged children
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.
Outcome measures
| Measure |
Experimental: Phase 1 Usual Exposure
n=348 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 1 Mealtime Support Activities
n=53 Participants
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).
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: Phase 2- Usual Exposure
n=125 Participants
Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas.
Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received
|
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
n=135 Participants
Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware
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.
|
|---|---|---|---|---|
|
Change in Frequency of Healthy Family Mealtimes
|
.08 mealtimes
Standard Deviation 2.16
|
.40 mealtimes
Standard Deviation 2.29
|
-.11 mealtimes
Standard Deviation 1.95
|
-.15 mealtimes
Standard Deviation 1.56
|
Adverse Events
Experimental: Phase 1 Usual Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Phase 1 Mealtime Support Activities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Phase 2- Usual Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Phase 2- Meal Delivery and Receipt of Cookware
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place