FirstStep2Health Intervention

NCT ID: NCT04164277

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2023-08-31

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.

Conditions

Pediatric Obesity; Risk Reduction Behavior; Early Intervention; Intergenerational Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caregiver Component.

Intervention Type: BEHAVIORAL

Facebook-based program including four new habit-formation tasks/week. Three face-to-face or virtual caregiver meetings: Meeting 1: Study orientation and healthy cooking education will be offered, and each family will receive a small bag of groceries to facilitate preparation of a recipe at home. Each caregiver will also receive an intervention cookbook containing affordable slow-cooking recipes, quick-fix recipes, and healthy snack ideas. Meeting 2: Study interveners will demonstrate how to spend less and shop healthy and how to read nutrition fact labels to promote healthy purchasing behaviors. Meeting 3: Study interveners will present healthy eating and PA community resources (e.g., farmer's markets, community gardens, nearly parks or other free or affordable PA facilities) and provide caregivers a resource booklet.

Caregiver-Preschooler Learning.

Intervention Type: BEHAVIORAL

Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent by the PM privately to each caregiver via Facebook messenger on two weekdays. Caregivers will be asked to answer two Facebook multiple-choice questions related to the letters each week by Sunday midnight (e.g., what foods listed in the their child's letter did the participant provide? and what activities listed in the their child's letter did the participant's family try?). Caregiver responses to the questions will be summed to indicate caregiver responses to child requests. Each preschooler's letters will be kept in his/her intervention binder with other intervention materials to present to his/her caregiver at Meeting 3. Weekly preschooler activities, with pictures or videos, will be shared with caregivers via the Facebook private group every week.

Center-based Preschooler Component.

Intervention Type: BEHAVIORAL

Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators. Session duration will be 20 minutes because children's normal attention span is 3-5 minutes per year of age, and 20 min/session is recommended for preschoolers. The already developed "Eat \& Walk My ABCs" curriculum will be implemented. The curriculum includes four components: healthy eating learning, taste-testing activities, movement skill training, and fun physical activity.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caregiver Component.

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.

Intervention Type: BEHAVIORAL

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 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.

Intervention Type: BEHAVIORAL

Center-based Preschooler Component.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Preschoolers must:

1. Have parental consent.

2. Have child assent if the child is 5 years old.

3. Be 3-5 years of age. The investigators prioritize this age group because intervening with preschoolers before age 5 results in better short- and long-term weight reduction outcomes than with children older than 5; and children who are at least 3 years-old have the motor and cognitive development to participate in a healthy eating and physical activity curriculum.

4. Be able to understand and speak English. The intervention will be delivered in English.

5. Be enrolled in the full-day or part-day Head Start program. Head Start offers part-day and full-day programs. To increase the generalizability of the study findings, preschoolers from both full-day and part-day programs will be recruited in this study.

Caregivers must:

1. Provide consent.

2. Be the primary adult caregiver (≥ 18 years old) for the preschooler. Primary caregiver refers to the one person most responsible for providing care to the preschooler on a daily basis.

3. Be able to read, understand, and speak English. The intervention will be delivered in English.

4. Have at least weekly Internet access using a smartphone, tablet, or a computer. Each caregiver needs to have Internet access to access the study Facebook site for participating in the Facebook-based program.

5. Be willing to use Facebook. Since the caregiver intervention component will be delivered via Facebook, caregivers need to be willing to use Facebook in the study.

Exclusion Criteria

1. Preschoolers or caregivers who have medical conditions precluding participating in dietary changes or physical activity.

2. Preschoolers or caregivers who have diagnosed health conditions known to impact weight (e.g., Prader-Willi Syndrome) or are taking weight-affecting medications (e.g., stimulants).

3. Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Jiying Ling

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Capital Area Community Services, Inc. Head Start and Early Childhood Programs

Lansing, Michigan, United States

Countries

United States

References

Ling J, Kao TA, Robbins LB, Kerver JM, Zhang N, Shi Y. Effects of the dyadic FirstStep2Health intervention on parents' behaviour and anthropometric outcomes: a secondary analysis of a cluster randomised trial. BMJ Open. 2024 Dec 5;14(12):e081578. doi: 10.1136/bmjopen-2023-081578.

Reference Type: DERIVED

PMID: 39638602 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21NR017958

Identifier Type: NIH

Identifier Source: org_study_id

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