Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This project will determine the preliminary efficacy of an innovative intergenerational intervention among Head Start preschoolers, aged 3-5 years, and their caregivers. A two-group cluster randomized controlled trial will be conducted. Six Head Start centers will be randomly assigned to the intervention (n=3) or control group (n=3), and an average of 6 caregiver-preschooler dyads will be recruited from each class (N=144 dyads from 16 classes). Grounded in an Actor-Partner Interdependence Model, the 16-week intervention has 3 components: 1) a caregiver component, including 1a) a Facebook-based program with weekly electronic retrievable flyers providing health information and behavioral change strategies and 4 weekly habit-formation tasks to improve parenting practices and home environment for preschoolers; and 1b) 3 face-to-face or virtual meetings (weeks 1, 8, & 16) to establish personal connections and communication networks among caregivers, discuss strategies, and share community resources to support preschoolers' behavioral changes at home; 2) a caregiver-preschooler learning component via Facebook messenger to send preschooler letters to each caregiver privately by the research team twice per week to 2a) share the preschooler's experiences of learning at school and his/her interests for a healthy diet and physical activity at home, and 2b) elicit caregivers' response to the letters; and 3) a Head Start center-based preschooler component to help preschoolers establish healthy habits via weekly healthy diet and physical activity participatory learning.
The purpose of this two-group cluster randomized controlled trial is to determine the preliminary efficacy of an innovative intergenerational intervention on improving preschoolers' moderate-to-vigorous physical activity and diet quality, and decreasing screen time, proportion of overweight and obesity, and body mass index z-score among Head Start preschoolers (aged 3-5 years) and their caregivers.
The intervention is guided by an Actor-Partner Interdependence Model, and will target both individual-level factors, including knowledge, self-efficacy, and skill, and socio-environmental factors, including parental support for child, parenting practices, and the home environment. The 16-week intervention has three components: 1) a caregiver component including 1a) a Facebook-based program with weekly electronic retrievable flyers providing health information and behavioral change strategies, and four weekly habit-formation tasks to create a healthier home environment for preschoolers; and 1b) three face-to-face or virtual meetings (weeks 1, 8, & 16) to establish personal connections and communication networks among caregivers and discuss strategies and share community resources to support behavioral changes at home; 2) a caregiver-preschooler learning component via Facebook messenger to send preschooler letters to each caregiver privately by the research team twice per week to share the preschooler's experiences of learning at school and his/her stated interests for healthy diet and physical activity at home, and to ask caregivers to respond to the letters; and 3) a Head Start center-based preschooler component to help preschoolers establish healthy habits via weekly healthy diet and PA participatory learning.
From the eligible 13 Head Start centers with at least three classrooms in one Head Start organization, six Head Start centers will be randomly selected and assigned to the intervention (n = 3) or control (n = 3) group with usual Head Start activities. Three to five classes will be randomly selected from each selected Head Start center to be involved in the study. In each class, six caregiver-preschooler dyads will be randomly selected from the eligible participants, and total 24 caregiver-preschooler dyads will be recruited from each center, yielding a total of 144 dyads.
Three specific AIMS are:
AIM 1: Determine the preliminary efficacy of FirstStep2Health vs control among preschoolers on improving proximal behavioral changes of moderate to vigorous physical activity measured by accelerometry (primary outcome); diet quality (e.g., fruits/vegetables, fiber, whole grains, total protein, dairy, sugar-sweetened beverages, total sugars/fats), and screen time (e.g., watching television, playing video games); and decreasing distal anthropometric outcomes of proportion of overweight or obese and body mass index z-score. The investigators expect an overall decrease in body mass index z-score in intervention preschoolers because overweight or obese preschoolers' body mass index z-score is expected to decrease while healthy-weight preschoolers will have no change. The investigators focus on proximal behavioral changes as our primary outcome instead of distal anthropometric outcomes due to the brevity of this study and the need for behavioral changes to be maintained for at least a year before manifesting in changes in anthropometric outcomes.
AIM 2: Examine the preliminary efficacy of FirstStep2Health vs control among caregivers on increasing their moderate to vigorous physical activity measured by accelerometry and diet quality; decreasing their screen time, proportion of overweight or obese, and body mass index; and improving their knowledge, feeding practice skill, self-efficacy, parental support of their child, parenting practices, and home environment.
AIM 3: Compare FirstStep2Health vs control on the bidirectional relationship between preschoolers and caregivers on moderate to vigorous physical activity, diet quality, and screen time.
Further, the investigators will validate established feasibility, acceptability, and satisfaction of the intervention using qualitative and quantitative data.
This study forms the foundation for conducting a future large-scale randomized controlled trial to reduce overweight and obesity among low-income preschoolers and their caregivers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The 16-week intervention includes three components:
|
|
| Control | No Intervention | Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver Component. | Behavioral | Facebook-based program including four new habit-formation tasks/week. Three face-to-face or virtual caregiver meetings: Meeting 1: Study orientation and healthy cooking education will be offered, and each family will receive a small bag of groceries to facilitate preparation of a recipe at home. Each caregiver will also receive an intervention cookbook containing affordable slow-cooking recipes, quick-fix recipes, and healthy snack ideas. Meeting 2: Study interveners will demonstrate how to spend less and shop healthy and how to read nutrition fact labels to promote healthy purchasing behaviors. Meeting 3: Study interveners will present healthy eating and PA community resources (e.g., farmer's markets, community gardens, nearly parks or other free or affordable PA facilities) and provide caregivers a resource booklet. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1 | The ActiGraph GT3X accelerometer (www.theactigraph.com) will record acceleration counts from which minutes of MVPA per day will be estimated (analysis software available). Each caregiver-preschooler dyad will receive the accelerometers at the same time and data collectors will explain to both caregiver and preschooler how to wear the accelerometers. Preschoolers' caregivers will be instructed to return monitors either at the Head Start center or via mail using using the provided prepaid envelope after the seventh day. Data will be downloaded to the same computer used to initialize monitors. Initial analysis will use 15-sec. epochs and the following count thresholds: moderate (420-841 counts/15 seconds) and vigorous PA (≥ 842 counts/15 seconds). Fifteen-second increments with counts ≥ 420 will be summed to determine minutes of MVPA. | Moderate-to-vigorous physical activity at 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fruit/Vegetable Intake (Preschoolers)-AIM 1 | Preschoolers' fruit/vegetable intake (servings/day) at home will be assessed by three non-consecutive 24-hour dietary recalls (one weekend day; two weekdays; randomly selected) with their caregivers over 2-3 weeks. The Project Manager will be trained at the University of Minnesota Nutrition Coordinating Center for two days and certified. The Project Manager will train interviewers to collect data individually from each caregiver via telephone. To aid in assessment of portion sizes, two-dimensional food models and measuring guides will be provided to caregivers at Head Start centers. Preschoolers' dietary intake at the Head Start center will be assessed by the dietary observation system on snacks and lunch on two selected weekdays (similar to the two weekdays selected for the 24-hour recall). The observed diet data will be entered into the Minnesota Nutrition Data System for Research for analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate-to-vigorous Physical Activity (MVPA; Caregivers)-AIM 2 | The ActiGraph GT3X-plus accelerometer (www.theactigraph.com) will record acceleration counts from which minutes of MVPA per day will be estimated (analysis software available). Data collection procedure for caregivers will be similar to those employed for preschoolers, but different count thresholds will be used: moderate (2690-6166 counts/60 seconds) and vigorous PA (≥ 6167 counts/60 seconds). Sixty-second increments with counts ≥ 2690 will be summed to determine minutes of MVPA. |
Inclusion Criteria. There are ten inclusion criteria (five for preschoolers and five for caregivers).
Preschoolers must:
Caregivers must:
Exclusion Criteria. There are three exclusion criteria for both caregivers and preschoolers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Area Community Services, Inc. Head Start and Early Childhood Programs | Lansing | Michigan | 48906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39638602 | Derived | Ling J, Kao TA, Robbins LB, Kerver JM, Zhang N, Shi Y. Effects of the dyadic FirstStep2Health intervention on parents' behaviour and anthropometric outcomes: a secondary analysis of a cluster randomised trial. BMJ Open. 2024 Dec 5;14(12):e081578. doi: 10.1136/bmjopen-2023-081578. | |
| 38622494 | Derived | Ling J, Suriyawong W, Robbins LB, Zhang N, Kerver JM. FirstStep2Health: A cluster randomised trial to promote healthy behaviours and prevent obesity amongst low-income preschoolers. Pediatr Obes. 2024 Jul;19(7):e13122. doi: 10.1111/ijpo.13122. Epub 2024 Apr 15. |
Not provided
Not provided
Data will be shared with other investigators upon request after securing a completed Data Use Agreement. We will adhere to the NIH Policy for Data Sharing from Clinical Trials and Epidemiological Studies. We will make any data not previously released and other study materials not previously distributed to individuals who are not study investigators available within three years of the end of NIH support for the study in accordance with the NIH Policy for Data Sharing. Only data that are stripped of personal identifiers and any personal health information will be shared.
Within three years of the end of NIH support for the study in accordance with the NIH Policy for Data Sharing
Data will be shared with other investigators upon request after securing a completed Data Use Agreement.
Not provided
53 caregiver-preschoolers dyads (53 caregivers, 53 preschoolers) from 10 daycare centers were enrolled in the study, and 10 daycare centers were randomly assigned into the intervention (5 daycare centers, 53 dyads) and control (5 daycare centers, 42 dyads) group.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The 16-week intervention includes three components:
|
| FG001 | Control | Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Preschoolers |
| |||||||||||||
| Caregivers |
|
The baseline sample included 53 caregiver-preschooler dyads (total 106 individuals, 53 caregivers, 53 preschoolers) in the intervention group and 42 caregiver-preschooler dyads (total 84 individuals, 42 caregivers, 42 preschoolers) in the control group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The 16-week intervention includes three components:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data from caregivers and preschoolers 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 | Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1 | The ActiGraph GT3X accelerometer (www.theactigraph.com) will record acceleration counts from which minutes of MVPA per day will be estimated (analysis software available). Each caregiver-preschooler dyad will receive the accelerometers at the same time and data collectors will explain to both caregiver and preschooler how to wear the accelerometers. Preschoolers' caregivers will be instructed to return monitors either at the Head Start center or via mail using using the provided prepaid envelope after the seventh day. Data will be downloaded to the same computer used to initialize monitors. Initial analysis will use 15-sec. epochs and the following count thresholds: moderate (420-841 counts/15 seconds) and vigorous PA (≥ 842 counts/15 seconds). Fifteen-second increments with counts ≥ 420 will be summed to determine minutes of MVPA. | Posted | Mean | Standard Deviation | Minutes per hour | Moderate-to-vigorous physical activity at 17 weeks |
|
Two years
The study participants are general preschoolers and their caregivers with relatively good health, so all-cause mortality rate is expected to be 0 among the 95 participants based on the rate of 1,043.8 deaths per 100,000 population in the US.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - Preschoolers | The 16-week intervention includes three components:
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiying Ling | Michigan State University | 5173538591 | lingjiyi@msu.edu |
Not provided
| 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 | Dec 22, 2023 | Dec 22, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
From the eligible 13 Head Start centers with at least three classrooms in one Head Start organization, six Head Start centers will be randomly selected and assigned to the intervention (n = 3) or control (n = 3) group with usual Head Start activities. Three to five classes will be randomly selected from each selected Head Start center to be involved in the study. In each class, six caregiver-preschooler dyads will be randomly selected from the eligible participants, and total 24 caregiver-preschooler dyads will be recruited from each center, yielding a total of 144 dyads.
Not provided
Not provided
Data collectors and interviewers will be blinded to the randomization.
|
| Caregiver-Preschooler Learning. | Behavioral | Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent by the PM privately to each caregiver via Facebook messenger on two weekdays. Caregivers will be asked to answer two Facebook multiple-choice questions related to the letters each week by Sunday midnight (e.g., what foods listed in the their child's letter did the participant provide? and what activities listed in the their child's letter did the participant's family try?). Caregiver responses to the questions will be summed to indicate caregiver responses to child requests. Each preschooler's letters will be kept in his/her intervention binder with other intervention materials to present to his/her caregiver at Meeting 3. Weekly preschooler activities, with pictures or videos, will be shared with caregivers via the Facebook private group every week. |
|
| Center-based Preschooler Component. | Behavioral | Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators. Session duration will be 20 minutes because children's normal attention span is 3-5 minutes per year of age, and 20 min/session is recommended for preschoolers. The already developed "Eat & Walk My ABCs" curriculum will be implemented. The curriculum includes four components: healthy eating learning, taste-testing activities, movement skill training, and fun physical activity. |
|
| Fruit/vegetable intake at 17 weeks |
| Screen Time (Preschoolers)-AIM 1 | Preschoolers' screen time will be assessed by two questions from the National Health and Nutrition Examination Survey (NHANES)-Physical Activity and Physical Fitness Survey. The two questions ask caregivers about the number of hours per day their preschooler watches television or videos and uses a computer or plays games. The scale has good reliability with coefficients ranging from 0.63 to 0.84. The sum score of the two questions (min-max: 0-24 hours/day) will be used to describe preschoolers' screen time, with a higher score indicating more screen time. Caregivers will complete the survey. | Screen time at 17 weeks |
| Number of Preschoolers Who Are Overweight or Obese-AIM 1 | Data collectors will measure each preschooler (bulky clothing, shoes, and things in pockets removed) in a private room. In accordance with NHANES measurement protocol, height without shoes will be measured to the nearest 0.1 cm. with a Shorr Board (Weigh and Measure, LLC, Olney, MD), and weight in kg. will be measured to the nearest 0.1 kg. using a Seca model 874 portable electronic scale (Seca Corp., Columbia, MD). Two measurements will be taken for height and weight. If the two differ by < 0.5 cm. and < 0.5 kg., they will be averaged to determine the final height and weight, respectively. If the two measurements differ by ≥ 0.5 cm. or by ≥ 0.5 kg, a third one will be taken. If the 3rd measurement is ≥ 0.5 cm or ≥ 0.5 kg. different from the previous two measurements, process will be repeated and another data collector will measure. BMI percentile and BMI z-score for age and sex will be determined via SAS program for CDC Growth Charts. | Proportion of overweight and obesity at 17 weeks |
| Moderate-to-vigorous physical activity at 17 weeks |
| Fruit/Vegetable Intake (Caregivers)-AIM 2: Block Fruit-Vegetable-Fiber Screener | The ten-item Block Fruit-Vegetable-Fiber Screener will assess the caregivers' fruit/vegetable intake (servings/day). This survey provides estimates for intake of food groups including total fruit/vegetable servings, dietary fiber (mg), Vitamin C (mg), magnesium (mg), and potassium (mg). The scale is significantly correlated with the full Block survey (r = 0.71). The established scoring equation will be used to calculate the number of servings of fruit/vegetable each participant consumes per day. | Diet quality at 17 weeks |
| Screen Time (Caregivers)-AIM 2 | Caregivers' screen time will also be assessed by two questions from the National Health and Nutrition Examination Survey (NHANES)-Physical Activity and Physical Fitness Survey. The sum of the two questions (min-max: 0-24 hours/day) will be used to describe preschoolers' screen time, with a higher score indicating more screen time. | Screen time at 17 weeks |
| Number of Caregivers Who Are Overweight or Obese-AIM 2 | BMI will be calculated based on weight (kg)/height (m2) and used to determine caregivers' weight status. Data collection procedures for caregivers will be similar to those employed for preschoolers. | Proportion of overweight and obesity at 17 weeks |
| Knowledge (Caregivers)-AIM 2 | The 25-item Parental Knowledge Scale will be used to assess parental knowledge on preschoolers' dietary intake and physical activity. The 2-point Likert scale has been used with low-income parents. It has two subscales: nutrition knowledge (score range 0-10), and physical activity knowledge (score range 0-15), with a higher sum score indicating greater knowledge on healthy eating or physical activity. | Knowledge at 17 weeks |
| Feeding Practice Skill (Caregivers)-AIM 2 | Parent feeding practice skill will be assessed by the 33-item Child Feeding Questionnaire. The Child Feeding Questionnaire was developed to evaluate parental beliefs, attitudes, and practices regarding child feeding, with a focus on obesity proneness in children aged 2-11 years old. The 5-point Likert questionnaire, with good reliability and validity, includes seven factors: perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, pressure to eat, restriction, and monitoring. The mean score of the items for each factor, with a range from 1 to 5, will be calculated, with a higher mean score indicating greater perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, pressure to eat, restriction, and monitoring, respectively. | Feeding practice skill at 17 weeks |
| Self-efficacy (Caregivers)-AIM 2 | The 20-item Parental Self-Efficacy Scale, measuring caregivers' confidence to support their preschoolers' healthy eating and physical activity, will assess caregiver self-efficacy. The 10-point Likert scale has shown good reliability with Cronbach's alphas ranging from 0.72 to 0.94. It has two subscales: nutrition self-efficacy (12 items) and physical activity self-efficacy (8 items). The mean score, with a range from 0 to 10, will be calculated for each subscale, with a higher mean score indicating greater self-efficacy. | Self-efficacy at 17 weeks |
| Parental Support (Caregivers)-AIM 2 | The 12-item Parental Support Scale for Eating Habits and Physical Activity will measure support for the child. The 6-point Likert scale has very good reliability with Cronbach's alphas ranging from 0.83 to 0.87. It has two subscales: nutrition support (7 items) and physical activity support (5 items). The mean score, with a range from 1 to 6, will be calculated for each subscale, with a higher mean score indicating greater parental support. | Parental support at 17 weeks |
| Parenting Practices (Caregivers)-AIM 2 | The 32-item Parenting Style and Dimensions Questionnaire will measure parenting practices. The 5-point Likert questionnaire is assessing three parenting styles: authoritative, authoritarian, and permissive. The questionnaire has good reliability with Cronbach's alphas ranging from 0.64 to 0.91. The mean score of items for each parenting style, with a range from 1 to 5, will be calculated, with a higher mean score indicating greater authoritative, authoritarian, or permissive parenting style, respectively. | Parenting practices at 17 weeks |
| Home Environment (Caregivers)-AIM 2 | The 20-item Family Nutrition and Physical Activity (FNPA) screening tool will assess the home environment. This 4-point Likert screening tool is used to assess home obesogenic environments and practices, including family meals, family eating practices, food choices, beverage choices, restriction/reward, screen time, healthy environment, family activity, child activity, and family schedule/sleep routine. It has two subscales: eating environment (10 items) and physical activity environment (10 items). The sum score of the 10 items, with a range from 20 to 40, will be calculated for each subscale, with a higher sum score indicating a healthier home environment. | Home environment at 17 weeks |
| NOT COMPLETED |
|
| BG001 | Control | Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male." | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The 16-week intervention includes three components:
|
| OG001 | Control | Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes. |
|
|
| Secondary | Fruit/Vegetable Intake (Preschoolers)-AIM 1 | Preschoolers' fruit/vegetable intake (servings/day) at home will be assessed by three non-consecutive 24-hour dietary recalls (one weekend day; two weekdays; randomly selected) with their caregivers over 2-3 weeks. The Project Manager will be trained at the University of Minnesota Nutrition Coordinating Center for two days and certified. The Project Manager will train interviewers to collect data individually from each caregiver via telephone. To aid in assessment of portion sizes, two-dimensional food models and measuring guides will be provided to caregivers at Head Start centers. Preschoolers' dietary intake at the Head Start center will be assessed by the dietary observation system on snacks and lunch on two selected weekdays (similar to the two weekdays selected for the 24-hour recall). The observed diet data will be entered into the Minnesota Nutrition Data System for Research for analysis. | Posted | Mean | Standard Deviation | Servings per day | Fruit/vegetable intake at 17 weeks |
|
|
|
| Secondary | Screen Time (Preschoolers)-AIM 1 | Preschoolers' screen time will be assessed by two questions from the National Health and Nutrition Examination Survey (NHANES)-Physical Activity and Physical Fitness Survey. The two questions ask caregivers about the number of hours per day their preschooler watches television or videos and uses a computer or plays games. The scale has good reliability with coefficients ranging from 0.63 to 0.84. The sum score of the two questions (min-max: 0-24 hours/day) will be used to describe preschoolers' screen time, with a higher score indicating more screen time. Caregivers will complete the survey. | Posted | Mean | Standard Deviation | Hours per day | Screen time at 17 weeks |
|
|
|
| Secondary | Number of Preschoolers Who Are Overweight or Obese-AIM 1 | Data collectors will measure each preschooler (bulky clothing, shoes, and things in pockets removed) in a private room. In accordance with NHANES measurement protocol, height without shoes will be measured to the nearest 0.1 cm. with a Shorr Board (Weigh and Measure, LLC, Olney, MD), and weight in kg. will be measured to the nearest 0.1 kg. using a Seca model 874 portable electronic scale (Seca Corp., Columbia, MD). Two measurements will be taken for height and weight. If the two differ by < 0.5 cm. and < 0.5 kg., they will be averaged to determine the final height and weight, respectively. If the two measurements differ by ≥ 0.5 cm. or by ≥ 0.5 kg, a third one will be taken. If the 3rd measurement is ≥ 0.5 cm or ≥ 0.5 kg. different from the previous two measurements, process will be repeated and another data collector will measure. BMI percentile and BMI z-score for age and sex will be determined via SAS program for CDC Growth Charts. | Posted | Count of Participants | Participants | Proportion of overweight and obesity at 17 weeks |
|
|
|
| Other Pre-specified | Moderate-to-vigorous Physical Activity (MVPA; Caregivers)-AIM 2 | The ActiGraph GT3X-plus accelerometer (www.theactigraph.com) will record acceleration counts from which minutes of MVPA per day will be estimated (analysis software available). Data collection procedure for caregivers will be similar to those employed for preschoolers, but different count thresholds will be used: moderate (2690-6166 counts/60 seconds) and vigorous PA (≥ 6167 counts/60 seconds). Sixty-second increments with counts ≥ 2690 will be summed to determine minutes of MVPA. | Posted | Mean | Standard Deviation | Minutes per hour | Moderate-to-vigorous physical activity at 17 weeks |
|
|
|
| Other Pre-specified | Fruit/Vegetable Intake (Caregivers)-AIM 2: Block Fruit-Vegetable-Fiber Screener | The ten-item Block Fruit-Vegetable-Fiber Screener will assess the caregivers' fruit/vegetable intake (servings/day). This survey provides estimates for intake of food groups including total fruit/vegetable servings, dietary fiber (mg), Vitamin C (mg), magnesium (mg), and potassium (mg). The scale is significantly correlated with the full Block survey (r = 0.71). The established scoring equation will be used to calculate the number of servings of fruit/vegetable each participant consumes per day. | Posted | Mean | Standard Deviation | Servings per day | Diet quality at 17 weeks |
|
|
|
| Other Pre-specified | Screen Time (Caregivers)-AIM 2 | Caregivers' screen time will also be assessed by two questions from the National Health and Nutrition Examination Survey (NHANES)-Physical Activity and Physical Fitness Survey. The sum of the two questions (min-max: 0-24 hours/day) will be used to describe preschoolers' screen time, with a higher score indicating more screen time. | Posted | Mean | Standard Deviation | Hours per day | Screen time at 17 weeks |
|
|
|
| Other Pre-specified | Number of Caregivers Who Are Overweight or Obese-AIM 2 | BMI will be calculated based on weight (kg)/height (m2) and used to determine caregivers' weight status. Data collection procedures for caregivers will be similar to those employed for preschoolers. | Posted | Count of Participants | Participants | Proportion of overweight and obesity at 17 weeks |
|
|
|
| Other Pre-specified | Knowledge (Caregivers)-AIM 2 | The 25-item Parental Knowledge Scale will be used to assess parental knowledge on preschoolers' dietary intake and physical activity. The 2-point Likert scale has been used with low-income parents. It has two subscales: nutrition knowledge (score range 0-10), and physical activity knowledge (score range 0-15), with a higher sum score indicating greater knowledge on healthy eating or physical activity. | Posted | Mean | Standard Deviation | score on a scale | Knowledge at 17 weeks |
|
|
|
| Other Pre-specified | Feeding Practice Skill (Caregivers)-AIM 2 | Parent feeding practice skill will be assessed by the 33-item Child Feeding Questionnaire. The Child Feeding Questionnaire was developed to evaluate parental beliefs, attitudes, and practices regarding child feeding, with a focus on obesity proneness in children aged 2-11 years old. The 5-point Likert questionnaire, with good reliability and validity, includes seven factors: perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, pressure to eat, restriction, and monitoring. The mean score of the items for each factor, with a range from 1 to 5, will be calculated, with a higher mean score indicating greater perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, pressure to eat, restriction, and monitoring, respectively. | Posted | Mean | Standard Deviation | score on a scale | Feeding practice skill at 17 weeks |
|
|
|
| Other Pre-specified | Self-efficacy (Caregivers)-AIM 2 | The 20-item Parental Self-Efficacy Scale, measuring caregivers' confidence to support their preschoolers' healthy eating and physical activity, will assess caregiver self-efficacy. The 10-point Likert scale has shown good reliability with Cronbach's alphas ranging from 0.72 to 0.94. It has two subscales: nutrition self-efficacy (12 items) and physical activity self-efficacy (8 items). The mean score, with a range from 0 to 10, will be calculated for each subscale, with a higher mean score indicating greater self-efficacy. | Posted | Mean | Standard Deviation | Mean score | Self-efficacy at 17 weeks |
|
|
|
| Other Pre-specified | Parental Support (Caregivers)-AIM 2 | The 12-item Parental Support Scale for Eating Habits and Physical Activity will measure support for the child. The 6-point Likert scale has very good reliability with Cronbach's alphas ranging from 0.83 to 0.87. It has two subscales: nutrition support (7 items) and physical activity support (5 items). The mean score, with a range from 1 to 6, will be calculated for each subscale, with a higher mean score indicating greater parental support. | Posted | Mean | Standard Deviation | score on a scale | Parental support at 17 weeks |
|
|
|
| Other Pre-specified | Parenting Practices (Caregivers)-AIM 2 | The 32-item Parenting Style and Dimensions Questionnaire will measure parenting practices. The 5-point Likert questionnaire is assessing three parenting styles: authoritative, authoritarian, and permissive. The questionnaire has good reliability with Cronbach's alphas ranging from 0.64 to 0.91. The mean score of items for each parenting style, with a range from 1 to 5, will be calculated, with a higher mean score indicating greater authoritative, authoritarian, or permissive parenting style, respectively. | Posted | Mean | Standard Deviation | Mean score | Parenting practices at 17 weeks |
|
|
|
| Other Pre-specified | Home Environment (Caregivers)-AIM 2 | The 20-item Family Nutrition and Physical Activity (FNPA) screening tool will assess the home environment. This 4-point Likert screening tool is used to assess home obesogenic environments and practices, including family meals, family eating practices, food choices, beverage choices, restriction/reward, screen time, healthy environment, family activity, child activity, and family schedule/sleep routine. It has two subscales: eating environment (10 items) and physical activity environment (10 items). The sum score of the 10 items, with a range from 20 to 40, will be calculated for each subscale, with a higher sum score indicating a healthier home environment. | Posted | Mean | Standard Deviation | score on a scale | Home environment at 17 weeks |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control - Preschoolers | Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | Intervention - Caregivers | The 16-week intervention includes three components:
| 0 | 53 | 0 | 53 | 0 | 53 |
| EG003 | Control - Caregivers | Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes. | 0 | 42 | 0 | 42 | 0 | 42 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Male |
|
| Perceived child weight |
|
| Concern about child weight |
|
| Restriction |
|
| Pressure to eat |
|
| Monitoring |
|
| Permissive |
|