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. In
Group
Value
95% CI
Intervention
7.51
± 3
Control
7.46
± 2.17
Fruit/Vegetable Intake (Preschoolers)-AIM 1Secondary· Fruit/vegetable intake at 17 weeks
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. Preschoole
Group
Value
95% CI
Intervention
3.60
± 2.01
Control
3.61
± 2.68
Screen Time (Preschoolers)-AIM 1Secondary· Screen time at 17 weeks
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.
Group
Value
95% CI
Intervention
3.70
± 2.99
Control
3.58
± 2.71
Number of Preschoolers Who Are Overweight or Obese-AIM 1Secondary· Proportion of overweight and obesity at 17 weeks
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.
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.
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.
Group
Value
95% CI
Intervention
4.52
± 2.46
Control
3.44
± 1.58
Screen Time (Caregivers)-AIM 2Secondary· Screen time at 17 weeks
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.
Group
Value
95% CI
Intervention
4.93
± 4.71
Control
5.93
± 5.67
Number of Caregivers Who Are Overweight or Obese-AIM 2Secondary· Proportion of overweight and obesity at 17 weeks
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.
Group
Value
95% CI
Intervention
23
Control
16
Knowledge (Caregivers)-AIM 2Secondary· Knowledge at 17 weeks
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.
Nutrition knowledge
Group
Value
95% CI
Intervention
7.45
± 1.27
Control
6.68
± 1.87
Physical activity knowledge
Group
Value
95% CI
Intervention
12.53
± 1.64
Control
11.58
± 8.18
Feeding Practice Skill (Caregivers)-AIM 2Secondary· Feeding practice skill at 17 weeks
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
Feeding responsibility
Group
Value
95% CI
Intervention
4.65
± 0.71
Control
4.58
± 0.64
Perceived parent weight
Group
Value
95% CI
Intervention
3.11
± 0.43
Control
3.31
± 0.46
Perceived child weight
Group
Value
95% CI
Intervention
2.95
± 0.32
Control
2.88
± 0.29
Concern about child weight
Group
Value
95% CI
Intervention
1.46
± 1.05
Control
1.13
± 0.26
Restriction
Group
Value
95% CI
Intervention
3.33
± 0.86
Control
3.37
± 0.87
Pressure to eat
Group
Value
95% CI
Intervention
2.86
± 0.99
Control
2.68
± 0.80
Monitoring
Group
Value
95% CI
Intervention
4.04
± 1.10
Control
4.13
± 0.83
Self-efficacy (Caregivers)-AIM 2Secondary· Self-efficacy at 17 weeks
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.
Nutrition self-efficacy
Group
Value
95% CI
Intervention
8.95
± 1.35
Control
8.18
± 1.68
Physical activity self-efficacy
Group
Value
95% CI
Intervention
9.27
± 1.12
Control
8.38
± 1.70
Parental Support (Caregivers)-AIM 2Secondary· Parental support at 17 weeks
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.
Nutrition support
Group
Value
95% CI
Intervention
4.52
± 0.80
Control
4.39
± 0.71
Physical activity support
Group
Value
95% CI
Intervention
5.15
± 1.05
Control
4.64
± 1.25
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Michigan State University
Last refreshed: 2 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04164277.