NCT04179565

Brief Summary

The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

September 7, 2018

Last Update Submit

March 8, 2022

Conditions

Keywords

childhood obesityparenting practicesfood and physical activity

Outcome Measures

Primary Outcomes (2)

  • Healthy Children, Healthy Families Checklist

    The checklist is a 16-item instrument that assesses parents'/caregivers' parenting and personal practices around food and physical activity, as well as the target child's food and physical activity practices. The checklist asks parents to report frequency (per day/week/month) of practices on 5-point Likert-type scales. The constructs measure parent diet quality and physical activity, child diet quality and physical activity, and parenting practices. Each question on the instrument is converted to a numeric value, 1 for the least desirable to 5 for most desirable response. The values for the entire instrument are summed (range 1 - 80 - only those checklists with at least one response are included) and divided by the number of items with a response (0 - 16), resulting in a mean score range of 0 - 5. The questions within each sub-scale are handled in the same way, with a sub-scale range of 0 - 5.

    up to 8 months

  • Comprehensive Feeding Practices Questionnaire (CFPQ)

    Six sub-scales (24 items) aligned with the learning objectives of the intervention, were selected from the original CFPQ. The constructs assessed by the sub-scales include encouraging balance and variety, use of food as reward, parent allowing child to control eating, parental modeling, parental pressure for child to consume more food, and home environment. Response options for 6 items include frequency on a Likert-type scale (never to always) and for 18 items include a Likert scale (strongly disagree to strongly agree). Each response is converted to a numeric value, 1 for the least desirable to 5 for the most desirable option. These values are then summed (range 0 - 120) and divided by the number of items with a response, resulting in a mean scale score range of 0 - 5. The items within each sub-scale are handled in the same way, with the sub-scale ranges of 0 - 5.

    up to 8 months

Secondary Outcomes (3)

  • Parental self-efficacy

    up to 8 months

  • Food frequency of sugar sweetened beverages and foods

    up to 8 months

  • Parent food choice behaviors

    up to 8 months

Study Arms (2)

Immediate intervention

ACTIVE COMPARATOR

The immediate education (IE) group will receive the intervention, Healthy Children, Healthy Families: Parents Making a Difference! in period 1. In period 2, IE will receive no education and will be followed longitudinally for periods 2 and 3.

Behavioral: Healthy Children Healthy Families

Delayed intervention

ACTIVE COMPARATOR

The delayed education (DE) group will serve as controls in period 1, receiving no intervention. In period 2, the treatments will cross over, so DE will receive the Healthy Children, Healthy Families: Parents Making a Difference! intervention.

Behavioral: Healthy Children Healthy Families

Interventions

The Healthy Children, Healthy Families: Parents Making a Difference! intervention was developed by the investigators for low-income parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain.

Delayed interventionImmediate intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jamie S Dollahite

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

November 27, 2019

Study Start

January 1, 2017

Primary Completion

August 30, 2018

Study Completion

December 31, 2019

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2020
Access Criteria
Data access requests will be reviewed by investigators within the Division of Nutritional Sciences at Cornell who were not involved in the study. Requestors will be required to sign a data access agreement.