NCT03071419

Brief Summary

This pilot study evaluates the feasibility and impact of a father-focused childhood obesity prevention program on paternal food-related parenting practices, mealtime behaviors and father/child nutrition and physical activity behaviors. Half of participants (low-income father and child dyads) will receive an intervention immediately while the other half of participants will serve as a wait-list control group and receive the intervention at a later date.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

February 26, 2017

Last Update Submit

June 4, 2019

Conditions

Pediatric Obesity

Keywords

fathers

Outcome Measures

Primary Outcomes (1)

  • Comprehensive Feeding Practices Questionnaire

    Food-related parenting practices including parental support, control, structure, feeding

    Change from baseline at 8 weeks

Secondary Outcomes (4)

  • Father & child diet quality

    Change from baseline at 8 weeks

  • Father & child BMI/BMI Z-Score

    Change from baseline at 8 weeks

  • Meals in Our Household questionnaire

    Change from baseline at 8 weeks

  • Healthy Kids Questionnaire

    Change from baseline at 8 weeks

Study Arms (2)

Nutrition and Parenting Intervention

EXPERIMENTAL

Participants (n=30, father/child dyads in groups of 10) will receive an 8 session (2 hours/session) community-based intervention including nutrition and parent education with between-session technology enhancements.

Behavioral: Nutrition and Parenting Intervention

Wait-list Control

ACTIVE COMPARATOR

Participants (n=30, father/child dyads in groups of 10) will serve as a wait-list control group and receive the same Nutrition and Parenting Intervention after completing pre and post assessments several weeks apart.

Behavioral: Nutrition and Parenting Intervention

Interventions

Nutrition and Parenting InterventionBEHAVIORAL

The proposed intervention will evaluate and explore the unique influences that low-income fathers have on their preschool age children's obesogenic behaviors and obesity risk.

Nutrition and Parenting InterventionWait-list Control

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Details"Father" will be defined as the main male figure with a relationship with the preschool aged child. This includes biological fathers, live-in boyfriends, stepfathers, grandfathers or other father figures.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • "Father" eligible for a federal food assistance or related program (e.g. SNAP) or living in an area with \>30% poverty
  • Having at least one preschool age child (ages 3-5 years old)
  • At least 18 years of age and able to speak English

You may not qualify if:

  • No presence or interaction with child during meal or snack times.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hockanum School, Head Start Program

East Hartford, Connecticut, 06118, United States

Location

Manchester Preschool Center

Manchester, Connecticut, 06042, United States

Location

Related Publications (1)

  • Mobley AR, Gans KM, Adamsons K, Huedo-Medina TB. Feasibility, Acceptability, and Preliminary Outcomes of a Father-Focused Childhood Obesity Prevention Program for Low-Income Families with Preschool-Age Children. Child Obes. 2023 Jan;19(1):13-24. doi: 10.1089/chi.2021.0225. Epub 2022 Mar 11.

    PMID: 35275734DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Amy R Mobley, PhD, RD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The interventionists will not be aware of whether participants are in the intervention or wait-list control group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 6, 2017

Study Start

December 1, 2016

Primary Completion

December 31, 2018

Study Completion

April 30, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)