An interventional study of Caregiver Component. and Caregiver-Preschooler Learning. in Pediatric Obesity, Risk Reduction Behavior and Early Intervention, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Michigan State University · Not applicable, Interventional, and Prevention
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.
1,126 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 95 is close to the median of 103 across 869 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Michigan State University is the lead sponsor of 141 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The 16-week intervention includes three components: 1. Caregiver Component. Facebook-based program including four new habit-formation tasks/week, and 3 face-to-face or virtual caregiver meetings: MSU research staff will lead the meetings at Head Start centers (weeks 1, 8, \& 16) to connect caregivers to each other, offer health information, and discuss behavioral change strategies. 2. Caregiver-Preschooler Learning. 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 privately to each caregiver , and caregivers will be asked to respond to the letters. 3. Center-based Preschooler Component. Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators.
Behavioral: Caregiver Component. · Behavioral: Caregiver-Preschooler Learning. · Behavioral: Center-based Preschooler Component.
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.
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.
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.
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.
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.
Time frame: Moderate-to-vigorous physical activity at 17 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Proportion of overweight and obesity at 17 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Home environment at 17 weeks
| Milestone | Intervention | Control |
|---|---|---|
| Started | 53 | 42 |
| Completed | 47 | 36 |
| Not completed | 6 | 6 |
| Milestone | Intervention | Control |
|---|---|---|
| Started | 53 | 42 |
| Completed | 47 | 36 |
| Not completed | 6 | 6 |
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.
| Minutes per hour | Intervention | Control |
|---|---|---|
| Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1 | 7.51 ± 3 | 7.46 ± 2.17 |
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.
| Servings per day | Intervention | Control |
|---|---|---|
| Fruit/Vegetable Intake (Preschoolers)-AIM 1 | 3.60 ± 2.01 | 3.61 ± 2.68 |
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.
| Hours per day | Intervention | Control |
|---|---|---|
| Screen Time (Preschoolers)-AIM 1 | 3.70 ± 2.99 | 3.58 ± 2.71 |
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.
| Participants | Intervention | Control |
|---|---|---|
| Number of Preschoolers Who Are Overweight or Obese-AIM 1 | 14 | 12 |
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.
| Minutes per hour | Intervention | Control |
|---|---|---|
| Moderate-to-vigorous Physical Activity (MVPA; Caregivers)-AIM 2 | 8.25 ± 6.75 | 10.14 ± 9.77 |
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.
| Servings per day | Intervention | Control |
|---|---|---|
| Fruit/Vegetable Intake (Caregivers)-AIM 2: Block Fruit-Vegetable-Fiber Screener | 4.52 ± 2.46 | 3.44 ± 1.58 |
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.
| Hours per day | Intervention | Control |
|---|---|---|
| Screen Time (Caregivers)-AIM 2 | 4.93 ± 4.71 | 5.93 ± 5.67 |
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.
| Participants | Intervention | Control |
|---|---|---|
| Number of Caregivers Who Are Overweight or Obese-AIM 2 | 23 | 16 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Nutrition knowledge | 7.45 ± 1.27 | 6.68 ± 1.87 |
| Physical activity knowledge | 12.53 ± 1.64 | 11.58 ± 8.18 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Feeding responsibility | 4.65 ± 0.71 | 4.58 ± 0.64 |
| Perceived parent weight | 3.11 ± 0.43 | 3.31 ± 0.46 |
| Perceived child weight | 2.95 ± 0.32 | 2.88 ± 0.29 |
| Concern about child weight | 1.46 ± 1.05 | 1.13 ± 0.26 |
| Restriction | 3.33 ± 0.86 | 3.37 ± 0.87 |
| Pressure to eat | 2.86 ± 0.99 | 2.68 ± 0.80 |
| Monitoring | 4.04 ± 1.10 | 4.13 ± 0.83 |
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.
| Mean score | Intervention | Control |
|---|---|---|
| Nutrition self-efficacy | 8.95 ± 1.35 | 8.18 ± 1.68 |
| Physical activity self-efficacy | 9.27 ± 1.12 | 8.38 ± 1.70 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Nutrition support | 4.52 ± 0.80 | 4.39 ± 0.71 |
| Physical activity support | 5.15 ± 1.05 | 4.64 ± 1.25 |
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.
| Mean score | Intervention | Control |
|---|---|---|
| Authoritative | 4.35 ± 0.52 | 4 ± 0.76 |
| Authoritarian | 2.46 ± 1.24 | 2.78 ± 0.91 |
| Permissive | 2.16 ± 0.84 | 2.41 ± 0.88 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Eating environment | 31.68 ± 4.13 | 30.74 ± 4.07 |
| Physical activity environment | 31.24 ± 4.78 | 28.42 ± 4.71 |
Collected over Two years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention - Preschoolers | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Control - Preschoolers | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Intervention - Caregivers | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Control - Caregivers | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
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.
| Age, Continuous(Years) | Intervention | Control | Total |
|---|---|---|---|
| Preschoolers | 4.12 ± 0.56 | 4.09 ± 0.57 | 4.11 ± 0.56 |
| Caregivers | 30.74 ± 6.11 | 30.02 ± 5.27 | 30.42 ± 5.73 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Preschoolers — Female | 26 | 29 | 55 |
| Preschoolers — Male | 27 | 13 | 40 |
| Caregivers — Female | 48 | 39 | 87 |
| Caregivers — Male | 4 | 3 | 7 |
| Race/Ethnicity, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Preschoolers: Hispanic preschoolers | 7 | 5 | 12 |
| Preschoolers: White or Caucasian | 10 | 21 | 31 |
| Preschoolers: Black or African American | 24 | 14 | 38 |
| Preschoolers: Asian/Pacific Islander | 3 | 0 | 3 |
| Preschoolers: Mixed Race | 15 | 7 | 22 |
| Preschoolers: American Indian or Alaskan Native | 1 | 0 | 1 |
| Caregivers: Hispanic | 3 | 5 | 8 |
| Caregivers: White or Caucasian | 18 | 26 | 44 |
| Caregivers: Black or African American | 23 | 12 | 35 |
| Caregivers: Asian/Pacific Islander | 3 | 0 | 3 |
| Caregivers: Mixed race | 6 | 3 | 9 |
| Caregivers: American Indian or Alaskan Native | 1 | 0 | 1 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 106 | 84 | 190 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Within three years of the end of NIH support for the study in accordance with the NIH Policy for Data Sharing
Access criteria: Data will be shared with other investigators upon request after securing a completed Data Use Agreement.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.