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The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.
Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal Kits, Then Newsletter + Food Pantry Referral | Experimental | Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral. |
|
| Newsletter + Food Pantry Referral, Then Meal Kits | Experimental | Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal Kit Delivery | Behavioral | Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility: Recruitment | Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization. | 2 months to baseline |
| Study Feasibility: Randomization | Number of participants enrolled per month, then subject to randomization. | At baseline |
| Study Feasibility: Retention | Number of participants retained at each study visit | At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16). |
| Study Feasibility: Protocol | Number of participants who reported receipt of all six weeks of meal kit delivery | Third study visit (week 14-16) |
| Study Feasibility: Adherence - Caregivers | Total number of recipes prepared by caregivers | Third study visit (week 14-16) |
| Study Feasibility: Adherence - Children | Number of children who tasted/ate food from the meal kit | Third study visit (week 14-16) |
| Study Feasibility: Assessments | Proportion of planned assessments completed at each study visit | At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Household Food Insecurity at the First Study Visit | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security | At the baseline first study visit (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Prime Diet Quality Score at Each Study Visit: Children | The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality. | At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) |
Child Inclusion Criteria:
Child Exclusion Criteria:
The child's primary caregiver will be eligible for enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Allison J Wu, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439559 | Derived | Wu AJ, Huggins M, Lin HG, Caballero-Gonzalez A, Dalvie N, Battista ED, Taveras EM, Fiechtner L. Satisfaction with a meal kit delivery program and feasibility of a phase I trial in the intervening in food insecurity to reduce and mitigate (InFoRM) childhood obesity study. Pediatr Obes. 2024 May;19(5):e13111. doi: 10.1111/ijpo.13111. Epub 2024 Mar 4. |
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Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, Institutional Review Board approval has been obtained, and all necessary data sharing agreements have been executed.
Data can be requested by emailing the PI.
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Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.
Recruitment was conducted at a primary care clinic between February and March 2023. The first participant was enrolled on February 13, 2023, and the last participant was enrolled on March 9, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Meal Kits, Then Newsletter + Food Pantry Referral: Caregivers | Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral. |
| FG001 | Meal Kits, Then Newsletter + Food Pantry Referral: Children | Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral. |
| FG002 | Newsletter + Food Pantry Referral, Then Meal Kits: Caregivers | Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). |
| FG003 | Newsletter + Food Pantry Referral, Then Meal Kits: Children | Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
|
| |||||||||||||||||||||
| Second Intervention (6 Weeks) |
|
Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Meal Kits, Then Newsletter + Food Pantry Referral | Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral. |
| BG001 | Newsletter + Food Pantry Referral, Then Meal Kits |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Caregivers and children were analyzed separately. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study Feasibility: Recruitment | Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization. | All participants who met eligibility criteria after being screened. | Posted | Count of Participants | Participants | 2 months to baseline |
|
|
Six weeks for each intervention.
Safety Population included all participants who received at least one meal kit or the newsletter + food pantry referral.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meal Kit Delivery: Caregivers | Caregivers who received weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). |
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Consistent with the goal of the pilot phase I study, the analysis is descriptive. This phase I study was not intended to be powered to detect changes in the secondary outcomes. Secondary outcomes were collected to determine the feasibility of the assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison Wu | Boston Children's Hospital | 6173556058 | allison.wu@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2023 | Feb 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009748 | Nutrition Disorders |
| D015362 | Child Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Dyads (caregiver + child) will be randomized to one of two intervention sequences:
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|
|
| Newsletter + Food Pantry Referral | Behavioral | Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry. |
|
|
| Number of Participants With Household Food Insecurity at Second Study Visit | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security | At second study visit (week 6-8) |
| Number of Participants With Household Food Insecurity at Third Study Visit | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security | At third study visit (week 14-16) |
| Change in BMI For Children With BMI Assessments At All Visits | Weight and height were combined to report BMI in kg/m^2 based on Centers for Disease Control growth curves. | At baseline, at second study visit (week 6-8), and at third study visit (week 14-16) |
| Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits | At baseline, at second study visit (week 6-8), and at third study visit (week 14-16) |
| Total Prime Diet Quality Score at Each Study Visit: Caregiver | The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality. | At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) |
| Caregiver Reported Mealtime Behavior at First Study Visit | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?" | At baseline first study visit (baseline) |
| Caregiver Reported Mealtime Behavior at Second Study Visit | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?" | At second study visit (week 6-8) |
| Caregiver Reported Mealtime Behavior at Third Study Visit | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?" | At third study visit (week 14-16) |
| Caregiver Perceived Stress at First Study Visit | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress | At baseline first study visit (baseline) |
| Caregiver Perceived Stress at Second Study Visit | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress | At second study visit (week 6-8) |
| Caregiver Perceived Stress at Third Study Visit | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress | At third study visit (week 14-16) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Caregivers and children were analyzed separately. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Caregivers and children were analyzed separately. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Caregivers and children were analyzed separately. | Count of Participants | Participants |
|
| Number of people living in the household | Only caregivers reported number of people living in the household. In the "Meal Kits, Then Newsletter + Food Pantry Referral" arm, one caregiver was missing information. | Median | Full Range | persons |
|
| Caregiver marital status | Only caregivers reported marital status. | Count of Participants | Participants |
|
| Total annual household income | Only caregivers reported household income. | Count of Participants | Participants |
|
| Highest grade or degree completed | Only caregivers reported their highest grade or degree completed. | Count of Participants | Participants |
|
| Caregiver relationship to child | Only caregivers reported their relationship to their child. | Count of Participants | Participants |
|
|
|
| Primary | Study Feasibility: Randomization | Number of participants enrolled per month, then subject to randomization. | All participants (caregivers and children) who consented to participate in the study. Randomization occurred by caregiver after completing the consent. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study. | Posted | Count of Participants | Participants | At baseline |
|
|
|
| Primary | Study Feasibility: Retention | Number of participants retained at each study visit | All participants enrolled in the study. | Posted | Count of Participants | Participants | At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16). |
|
|
|
| Primary | Study Feasibility: Protocol | Number of participants who reported receipt of all six weeks of meal kit delivery | All participants with assessment data at the third study visit. | Posted | Count of Participants | Participants | Third study visit (week 14-16) |
|
|
|
| Primary | Study Feasibility: Adherence - Caregivers | Total number of recipes prepared by caregivers | All caregivers with assessment data at the third study visit. | Posted | Count of Participants | Participants | Third study visit (week 14-16) |
|
|
|
| Primary | Study Feasibility: Adherence - Children | Number of children who tasted/ate food from the meal kit | All caregivers with assessment data at the third study visit. | Posted | Count of Participants | Participants | Third study visit (week 14-16) |
|
|
|
| Primary | Study Feasibility: Assessments | Proportion of planned assessments completed at each study visit | The first study visit included a baseline demographic survey, 2 child assessments, and 1 caregiver assessment. The second study visit included 2 child assessments and 1 parent assessment. The third study visit included 2 child assessments, 1 parent assessment, and 1 satisfaction questionnaire. The "Meal Kit Delivery, Then Newsletter + Food Pantry Referral" arm included 14 caregivers and 15 children (one pair of siblings), thus the discrepancy between total planned assessments in each arm. | Posted | Count of Units | Survey/Assessments | At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) | Survey/Assessments | Survey/Assessments |
|
|
|
| Secondary | Number of Participants With Household Food Insecurity at the First Study Visit | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security | Caregivers who reported household-level food security at baseline study visit 1 (baseline). | Posted | Count of Participants | Participants | At the baseline first study visit (baseline) |
|
|
|
| Secondary | Number of Participants With Household Food Insecurity at Second Study Visit | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security | Caregivers who reported household-level food security at study visit 2 (week 6-8). | Posted | Count of Participants | Participants | At second study visit (week 6-8) |
|
|
|
| Secondary | Number of Participants With Household Food Insecurity at Third Study Visit | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security | Caregivers who reported household-level food security at third study visit (week 14-16). | Posted | Count of Participants | Participants | At third study visit (week 14-16) |
|
|
|
| Secondary | Change in BMI For Children With BMI Assessments At All Visits | Weight and height were combined to report BMI in kg/m^2 based on Centers for Disease Control growth curves. | Children with BMI data at three study visits. | Posted | Mean | Standard Deviation | kg/m^2 | At baseline, at second study visit (week 6-8), and at third study visit (week 14-16) |
|
|
|
| Secondary | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits | Children with BMI data at all three study visits. | Posted | Mean | Standard Deviation | percentage of the 95th percentile | At baseline, at second study visit (week 6-8), and at third study visit (week 14-16) |
|
|
|
| Other Pre-specified | Total Prime Diet Quality Score at Each Study Visit: Children | The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality. | Children with dietary data at study visits. | Posted | Mean | Standard Deviation | units on a scale | At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) |
|
|
|
| Other Pre-specified | Total Prime Diet Quality Score at Each Study Visit: Caregiver | The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality. | Parents with dietary data at study visits. | Posted | Mean | Standard Deviation | score on a scale | At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) |
|
|
|
| Other Pre-specified | Caregiver Reported Mealtime Behavior at First Study Visit | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?" | Children with parent-reported data on mealtime behavior. | Posted | Count of Participants | Participants | At baseline first study visit (baseline) |
|
|
|
| Other Pre-specified | Caregiver Reported Mealtime Behavior at Second Study Visit | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?" | Children with parent-reported mealtime behavior data. | Posted | Count of Participants | Participants | At second study visit (week 6-8) |
|
|
|
| Other Pre-specified | Caregiver Reported Mealtime Behavior at Third Study Visit | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?" | Children with parent-reported mealtime behavior data. | Posted | Count of Participants | Participants | At third study visit (week 14-16) |
|
|
|
| Other Pre-specified | Caregiver Perceived Stress at First Study Visit | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress | Caregivers with perceived stress data. | Posted | Count of Participants | Participants | At baseline first study visit (baseline) |
|
|
|
| Other Pre-specified | Caregiver Perceived Stress at Second Study Visit | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress | Caregivers with perceived stress data. | Posted | Count of Participants | Participants | At second study visit (week 6-8) |
|
|
|
| Other Pre-specified | Caregiver Perceived Stress at Third Study Visit | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress | Caregivers with perceived stress data. | Posted | Count of Participants | Participants | At third study visit (week 14-16) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Meal Kit Delivery: Children | Children who received weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Newsletter + Food Pantry Referral: Caregivers | Caregivers who received a newsletter and food pantry referral. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Newsletter + Food Pantry Referral: Children | Children who received a newsletter and food pantry referral. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Divorced |
|
| Separated |
|
| Widowed |
|
| Prefer not to answer |
|
| Missing |
|
| More than $70,000 |
|
| Don't know |
|
| Prefer not to answer |
|
| Missing |
|
| High school graduate |
|
| Some college or technical school |
|
| College graduate |
|
| Postgraduate training or degree |
|
| Don't know or prefer not to answer |
|
| Missing |
|
| Missing |
|
|
| Second study visit |
|
|
| Third study visit |
|
|
| Caregivers who prepared 1-2 recipes |
|
| Caregivers who did not prepare any recipe |
|
|
| Planned assessments completed after visit 2 |
|
|
| Planned assessments completed after visit 3 |
|
|
| Low food security |
|
| Very low food security |
|
| Low food security |
|
| Very low food security |
|
| Low food security |
|
| Very low food security |
|
| BMI at Visit 3 |
|
| Change from Baseline at Visit 2 |
|
| Change from Baseline at Visit 3 |
|
| Change from Visit 2 and Visit 3 |
|
| BMIp95 at Visit 3 |
|
| Change from Baseline at Visit 2 |
|
| Change from Baseline at Visit 3 |
|
| Change from Visit 2 to Visit 3 |
|
| Child Prime Diet Quality Score (PDQS) at Visit 2 |
|
|
| Child Prime Diet Quality Score (PDQS) at Visit 3 |
|
|
| Caregiver Prime Diet Quality Score (PDQS) at Visit 2 |
|
|
| Caregiver Prime Diet Quality Score (PDQS) at Visit 3 |
|
|
| 2-4 times per week |
|
| 5-6 times per week |
|
| Everyday |
|
| 2-4 times per week |
|
| 5-6 times per week |
|
| Everyday |
|
| 2-4 times per week |
|
| 5-6 times per week |
|
| Everyday |
|
| Low perceived stress |
|
| Low perceived stress |
|
| Low perceived stress |
|
| Participants lost to follow up in study visit |
|
| Participants lost to follow up in study visit |
|