FirstStep2Health Intervention

Not Applicable

Completed

Conditions: Pediatric Obesity
Intergenerational Relations
Risk Reduction Behavior
Early Intervention

Interventions: Behavioral: Caregiver Component.
Behavioral: Caregiver-Preschooler Learning.
Behavioral: Center-based Preschooler Component.

Registration Number: NCT04164277

Lead Sponsor: Michigan State University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Caregiver-Preschooler Learning.	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.
Intervention	Caregiver Component.	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.
Intervention	Center-based Preschooler Component.	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.

Primary Outcome Measures

Name	Time	Method
Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1	Moderate-to-vigorous physical activity at 17 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Fruit/Vegetable Intake (Preschoolers)-AIM 1	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. 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.
Screen Time (Preschoolers)-AIM 1	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.
Number of Preschoolers Who Are Overweight or Obese-AIM 1	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. 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.