FirstStep2Health Intervention

NCT04164277 | Completed Results DMC

• 1 other identifier: R21NR017958
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obesity prevention, early childhood, intergenerational, family-based

Outcome Measures

Primary Outcomes (1)

• 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.

  Moderate-to-vigorous physical activity at 17 weeks

Secondary Outcomes (3)

• Fruit/Vegetable Intake (Preschoolers)-AIM 1

  Fruit/vegetable intake at 17 weeks

• Screen Time (Preschoolers)-AIM 1

  Screen time at 17 weeks

• Number of Preschoolers Who Are Overweight or Obese-AIM 1

  Proportion of overweight and obesity at 17 weeks

Other Outcomes (10)

• Moderate-to-vigorous Physical Activity (MVPA; Caregivers)-AIM 2

  Moderate-to-vigorous physical activity at 17 weeks

• Fruit/Vegetable Intake (Caregivers)-AIM 2: Block Fruit-Vegetable-Fiber Screener

  Diet quality at 17 weeks

• Screen Time (Caregivers)-AIM 2

  Screen time at 17 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

NO INTERVENTION

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.

Interventions

Caregiver Component. 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.

Intervention

Caregiver-Preschooler Learning. 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.

Intervention

Center-based Preschooler Component. 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.

Intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preschoolers must:
• Have parental consent.
• Have child assent if the child is 5 years old.
• 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.
• Be able to understand and speak English. The intervention will be delivered in English.
• 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:
• Provide consent.
• 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.
• Be able to read, understand, and speak English. The intervention will be delivered in English.
• 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.
• 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.

You may not qualify if:

• Preschoolers or caregivers who have medical conditions precluding participating in dietary changes or physical activity.
• 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).
• Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

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

Lansing, Michigan, 48906, United States

Location

Related Publications (1)

• 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.

  PMID: 39638602 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Jiying Ling
• Organization: Michigan State University

lingjiyi@msu.edu

5173538591

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors and interviewers will be blinded to the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 15, 2019
• Study Start: September 20, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 2, 2024
• Results First Posted: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• 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.

Locations

US (1)