Obesity
Conditions
Keywords
Obesity, Family Mealtimes, Prevention
Brief summary
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
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.
Interventions
BEHAVIORALMealtime 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.
BEHAVIORALUsual Exposure
Participants receive no supplemental information on family mealtimes beyond what is already currently received
Sponsors
University of Michigan
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMIz | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Quality-Observed Fruit | 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. |
| Change in Dietary Quality- Observed Vegetables | 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 |
| Change in Dietary Quality-Parent Reported Fruit Intake | 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 |
| Change in Dietary Quality-Parent Reported Vegetables | 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. |
| Change in Frequency of Healthy Family Mealtimes | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 434 |
| 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. | 65 |
| 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 | 152 |
| 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. | 159 |
| Total | 810 |
Baseline characteristics
| Characteristic | Experimental: Phase 1 Usual Exposure | Experimental: Phase 1 Mealtime Support Activities | Experimental: Phase 2- Usual Exposure | Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Total |
|---|---|---|---|---|---|
| Age, Continuous | 30.0 years STANDARD_DEVIATION 6.9 | 28.7 years STANDARD_DEVIATION 5.6 | 33.9 years STANDARD_DEVIATION 5.8 | 34.0 years STANDARD_DEVIATION 5.8 | 31.65 years STANDARD_DEVIATION 2.71 |
| Child BMIz | .64 zscore STANDARD_DEVIATION 1.07 | .72 zscore STANDARD_DEVIATION 1.1 | .34 zscore STANDARD_DEVIATION 1.03 | .40 zscore STANDARD_DEVIATION 1.04 | .56 zscore STANDARD_DEVIATION 1.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants | 5 Participants | 17 Participants | 19 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 398 Participants | 60 Participants | 136 Participants | 138 Participants | 738 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Parent BMI | 31.51 mean STANDARD_DEVIATION 13.96 | 30.44 mean STANDARD_DEVIATION 8.5 | 29.75 mean STANDARD_DEVIATION 13.3 | 29.85 mean STANDARD_DEVIATION 8.63 | 30.39 mean STANDARD_DEVIATION 0.81 |
| Sex: Female, Male Female | 416 Participants | 25 Participants | 139 Participants | 89 Participants | 761 Participants |
| Sex: Female, Male Male | 214 Participants | 40 Participants | 77 Participants | 70 Participants | 401 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 434 | 0 / 65 | 0 / 152 | 0 / 159 |
| other Total, other adverse events | 0 / 434 | 0 / 65 | 0 / 152 | 0 / 159 |
| serious Total, serious adverse events | 0 / 434 | 0 / 65 | 0 / 152 | 0 / 159 |
Outcome results
Primary
Change in BMIz
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
Time frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Population: Preschool aged children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Phase 1 Usual Exposure | Change in BMIz | .0060 z-score | Standard Deviation 0.39 |
| Experimental: Phase 1 Mealtime Support Activities | Change in BMIz | .00027 z-score | Standard Deviation 0.37 |
| Experimental: Phase 2- Usual Exposure | Change in BMIz | .04 z-score | Standard Deviation 0.44 |
| Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Change in BMIz | -.02 z-score | Standard Deviation 0.38 |
Comparison: We tested change in BMIz for each of the four study arms/groups.p-value: 0.34Mixed Models Analysis
Secondary
Change in Dietary Quality-Observed Fruit
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Phase 2- Usual Exposure | Change in Dietary Quality-Observed Fruit | -.03 cup equivalent | Standard Deviation 0.26 |
| Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Change in Dietary Quality-Observed Fruit | -.04 cup equivalent | Standard Deviation 0.27 |
Comparison: We tested change in observed fruit intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups.p-value: 0.62Mixed Models Analysis
Secondary
Change in Dietary Quality- Observed Vegetables
Report of the child's usual eating habits (fruit) using the Pennington Remote Food Photography Method
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Phase 2- Usual Exposure | Change in Dietary Quality- Observed Vegetables | -.01 cup equivalent | Standard Deviation 0.13 |
| Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Change in Dietary Quality- Observed Vegetables | .05 cup equivalent | Standard Deviation 0.15 |
Comparison: We tested pre to post change in observed vegetable intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups. Positive Observed dietary quality data was not collected in Phase 1.p-value: 0.009Mixed Models Analysis
Secondary
Change in Dietary Quality-Parent Reported Fruit Intake
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
Time frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Population: Parents of preschool aged children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Phase 1 Usual Exposure | Change in Dietary Quality-Parent Reported Fruit Intake | -.04 cup equivalent | Standard Deviation 0.86 |
| Experimental: Phase 1 Mealtime Support Activities | Change in Dietary Quality-Parent Reported Fruit Intake | .09 cup equivalent | Standard Deviation 1.01 |
| Experimental: Phase 2- Usual Exposure | Change in Dietary Quality-Parent Reported Fruit Intake | -.21 cup equivalent | Standard Deviation 0.71 |
| Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Change in Dietary Quality-Parent Reported Fruit Intake | -.10 cup equivalent | Standard Deviation 0.73 |
Comparison: We tested pre to post change in parent reported child fruit intake for each of the four study arms/groups.p-value: 0.21Mixed Models Analysis
Secondary
Change in Dietary Quality-Parent Reported Vegetables
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.
Time frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Population: Parents of preschool aged children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Phase 1 Usual Exposure | Change in Dietary Quality-Parent Reported Vegetables | -.02 cup equivalent | Standard Deviation 0.37 |
| Experimental: Phase 1 Mealtime Support Activities | Change in Dietary Quality-Parent Reported Vegetables | .04 cup equivalent | Standard Deviation 0.35 |
| Experimental: Phase 2- Usual Exposure | Change in Dietary Quality-Parent Reported Vegetables | -.06 cup equivalent | Standard Deviation 0.3 |
| Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Change in Dietary Quality-Parent Reported Vegetables | -.04 cup equivalent | Standard Deviation 0.29 |
Comparison: We tested change in vegetable intake for each of the four study arms/groups.p-value: 0.55Mixed Models Analysis
Secondary
Change in Frequency of Healthy Family Mealtimes
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.
Time frame: Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).
Population: Parents of preschool aged children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Phase 1 Usual Exposure | Change in Frequency of Healthy Family Mealtimes | .08 mealtimes | Standard Deviation 2.16 |
| Experimental: Phase 1 Mealtime Support Activities | Change in Frequency of Healthy Family Mealtimes | .40 mealtimes | Standard Deviation 2.29 |
| Experimental: Phase 2- Usual Exposure | Change in Frequency of Healthy Family Mealtimes | -.11 mealtimes | Standard Deviation 1.95 |
| Experimental: Phase 2- Meal Delivery and Receipt of Cookware | Change in Frequency of Healthy Family Mealtimes | -.15 mealtimes | Standard Deviation 1.56 |
Comparison: We tested change in frequency of family mealtimes for each of the four study arms/groups.p-value: 0.84Mixed Models Analysis