Trial Outcomes & Findings for FirstStep2Health Intervention (NCT NCT04164277)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

Moderate-to-vigorous physical activity at 17 weeks

Results posted on

2024-08-02

Participant Flow

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.

Unit of analysis: Daycare centers

Participant milestones

Participant milestones
Measure	Intervention 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.	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.
Preschoolers STARTED	53 5	42 5
Preschoolers COMPLETED	47 5	36 5
Preschoolers NOT COMPLETED	6 0	6 0
Caregivers STARTED	53 5	42 5
Caregivers COMPLETED	47 5	36 5
Caregivers NOT COMPLETED	6 0	6 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data from caregivers and preschoolers were analyzed separately.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1	7.51 Minutes per hour Standard Deviation 3	7.46 Minutes per hour Standard Deviation 2.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Fruit/Vegetable Intake (Preschoolers)-AIM 1	3.60 Servings per day Standard Deviation 2.01	3.61 Servings per day Standard Deviation 2.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Screen Time (Preschoolers)-AIM 1	3.70 Hours per day Standard Deviation 2.99	3.58 Hours per day Standard Deviation 2.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Number of Preschoolers Who Are Overweight or Obese-AIM 1	14 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Moderate-to-vigorous physical activity at 17 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Moderate-to-vigorous Physical Activity (MVPA; Caregivers)-AIM 2	8.25 Minutes per hour Standard Deviation 6.75	10.14 Minutes per hour Standard Deviation 9.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Diet quality at 17 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Fruit/Vegetable Intake (Caregivers)-AIM 2: Block Fruit-Vegetable-Fiber Screener	4.52 Servings per day Standard Deviation 2.46	3.44 Servings per day Standard Deviation 1.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Screen Time (Caregivers)-AIM 2	4.93 Hours per day Standard Deviation 4.71	5.93 Hours per day Standard Deviation 5.67

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants 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.	Control n=20 Participants 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.
Number of Caregivers Who Are Overweight or Obese-AIM 2	23 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Knowledge (Caregivers)-AIM 2 Nutrition knowledge	7.45 score on a scale Standard Deviation 1.27	6.68 score on a scale Standard Deviation 1.87
Knowledge (Caregivers)-AIM 2 Physical activity knowledge	12.53 score on a scale Standard Deviation 1.64	11.58 score on a scale Standard Deviation 8.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 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, 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Feeding Practice Skill (Caregivers)-AIM 2 Feeding responsibility	4.65 score on a scale Standard Deviation 0.71	4.58 score on a scale Standard Deviation 0.64
Feeding Practice Skill (Caregivers)-AIM 2 Perceived parent weight	3.11 score on a scale Standard Deviation 0.43	3.31 score on a scale Standard Deviation 0.46
Feeding Practice Skill (Caregivers)-AIM 2 Perceived child weight	2.95 score on a scale Standard Deviation 0.32	2.88 score on a scale Standard Deviation 0.29
Feeding Practice Skill (Caregivers)-AIM 2 Concern about child weight	1.46 score on a scale Standard Deviation 1.05	1.13 score on a scale Standard Deviation 0.26
Feeding Practice Skill (Caregivers)-AIM 2 Restriction	3.33 score on a scale Standard Deviation 0.86	3.37 score on a scale Standard Deviation 0.87
Feeding Practice Skill (Caregivers)-AIM 2 Pressure to eat	2.86 score on a scale Standard Deviation 0.99	2.68 score on a scale Standard Deviation 0.80
Feeding Practice Skill (Caregivers)-AIM 2 Monitoring	4.04 score on a scale Standard Deviation 1.10	4.13 score on a scale Standard Deviation 0.83

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Self-efficacy (Caregivers)-AIM 2 Nutrition self-efficacy	8.95 Mean score Standard Deviation 1.35	8.18 Mean score Standard Deviation 1.68
Self-efficacy (Caregivers)-AIM 2 Physical activity self-efficacy	9.27 Mean score Standard Deviation 1.12	8.38 Mean score Standard Deviation 1.70

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Parental Support (Caregivers)-AIM 2 Nutrition support	4.52 score on a scale Standard Deviation 0.80	4.39 score on a scale Standard Deviation 0.71
Parental Support (Caregivers)-AIM 2 Physical activity support	5.15 score on a scale Standard Deviation 1.05	4.64 score on a scale Standard Deviation 1.25

OTHER_PRE_SPECIFIED outcome

Timeframe: Parenting practices at 17 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Parenting Practices (Caregivers)-AIM 2 Authoritative	4.35 Mean score Standard Deviation 0.52	4 Mean score Standard Deviation 0.76
Parenting Practices (Caregivers)-AIM 2 Authoritarian	2.46 Mean score Standard Deviation 1.24	2.78 Mean score Standard Deviation 0.91
Parenting Practices (Caregivers)-AIM 2 Permissive	2.16 Mean score Standard Deviation 0.84	2.41 Mean score Standard Deviation 0.88

OTHER_PRE_SPECIFIED outcome

Timeframe: Home environment at 17 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=53 Participants 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.	Control n=42 Participants 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.
Home Environment (Caregivers)-AIM 2 Eating environment	31.68 score on a scale Standard Deviation 4.13	30.74 score on a scale Standard Deviation 4.07
Home Environment (Caregivers)-AIM 2 Physical activity environment	31.24 score on a scale Standard Deviation 4.78	28.42 score on a scale Standard Deviation 4.71

Adverse Events

Intervention - Preschoolers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Preschoolers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention - Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jiying Ling

Michigan State University

Phone: 5173538591

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention n=106 Participants 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.	Control n=84 Participants 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.	Total n=190 Participants Total of all reporting groups
Age, Continuous Preschoolers	4.12 Years STANDARD_DEVIATION 0.56 • n=53 Participants • Data from caregivers and preschoolers were analyzed separately.	4.09 Years STANDARD_DEVIATION 0.57 • n=42 Participants • Data from caregivers and preschoolers were analyzed separately.	4.11 Years STANDARD_DEVIATION 0.56 • n=95 Participants • Data from caregivers and preschoolers were analyzed separately.
Age, Continuous Caregivers	30.74 Years STANDARD_DEVIATION 6.11 • n=53 Participants • Data from caregivers and preschoolers were analyzed separately.	30.02 Years STANDARD_DEVIATION 5.27 • n=42 Participants • Data from caregivers and preschoolers were analyzed separately.	30.42 Years STANDARD_DEVIATION 5.73 • n=95 Participants • Data from caregivers and preschoolers were analyzed separately.
Sex: Female, Male Preschoolers · Female	26 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	29 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	55 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."
Sex: Female, Male Preschoolers · Male	27 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	13 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	40 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."
Sex: Female, Male Caregivers · Female	48 Participants n=52 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	39 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	87 Participants n=94 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."
Sex: Female, Male Caregivers · Male	4 Participants n=52 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	3 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."	7 Participants n=94 Participants • Data from caregivers and preschoolers were analyzed separately. Caregivers could select more than one choice and one caregivers selected both "female" and "male."
Race/Ethnicity, Customized Preschoolers: Hispanic preschoolers	7 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	5 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	12 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Preschoolers: White or Caucasian	10 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	21 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	31 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Preschoolers: Black or African American	24 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	14 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	38 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Preschoolers: Asian/Pacific Islander	3 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	0 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	3 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Preschoolers: Mixed Race	15 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	7 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	22 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Preschoolers: American Indian or Alaskan Native	1 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	0 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	1 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Caregivers: Hispanic	3 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	5 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	8 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Caregivers: White or Caucasian	18 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	26 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	44 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Caregivers: Black or African American	23 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	12 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	35 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Caregivers: Asian/Pacific Islander	3 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	0 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	3 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Caregivers: Mixed race	6 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	3 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	9 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Race/Ethnicity, Customized Caregivers: American Indian or Alaskan Native	1 Participants n=53 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	0 Participants n=42 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.	1 Participants n=95 Participants • Data from caregivers and preschoolers were analyzed separately. Participants could select more than one choice making the Rows not mutually exclusive.
Region of Enrollment United States	106 participants n=106 Participants	84 participants n=84 Participants	190 participants n=190 Participants