NCT02973815

Brief Summary

The goal of the proposed project is to see if an innovative family-based intervention can reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors in the home. In addition, the project will also examine how the NU-HOME family intervention influences children's dietary intake, availability of healthy and unhealthy foods in the home and served at meals and snacks, physical activity as a family, and child screen time (TV, game systems). The study will build upon a similar project conducted in an urban area and translate the lessons learned and adapt the program for a rural community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 7, 2022

Completed
Last Updated

October 7, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

November 8, 2016

Results QC Date

March 31, 2022

Last Update Submit

September 11, 2022

Conditions

Keywords

family mealshome food availability

Outcome Measures

Primary Outcomes (1)

  • Change in Child Body Mass Index (BMI) Z-score

    Trained study staff will measure weight and height to calculate body mass index (BMI) then adjust for the child's age and sex to get BMI percentiles and z-scores. A Z-score of 0 represents the population mean with a z-score above zero indicating BMI above the population mean and a negative z-score indicating values below the population mean.

    Post intervention (9 months after baseline)

Secondary Outcomes (7)

  • Change in Home Availability of Fruits

    Post intervention (9 months after baseline)

  • Change in Home Availability of Vegetables

    Post Intervention (9 months after baseline)

  • Change in the Quality of Food and Beverages Served at Family Meals

    Post intervention (9 months after baseline)

  • Change in Dietary Intake of Vegetables

    Post intervention (9 months after baseline)

  • Change in Child Dietary Intake of Fruit

    Post intervention (9 months after baseline)

  • +2 more secondary outcomes

Study Arms (2)

NU-HOME Intervention

EXPERIMENTAL

Participants randomized to the intervention condition will receive the NU-HOME family intervention program that includes group sessions with other families focused on nutrition education, cooking skills, and physical activity. The intervention program also includes individual goal setting phone calls with parents and online, complementary materials.

Behavioral: NU-HOME Intervention

Delayed Intervention

NO INTERVENTION

Participants randomized to the delayed intervention condition will not receive any educational materials or training until after the final data collection. Once all data collection is completed, they will receive a shortened version of the NU-HOME intervention program that was offered to the intervention families.

Interventions

The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.

NU-HOME Intervention

Eligibility Criteria

Age7 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • child between the ages of 7-10 who lives with the target adult at least 50% of the time
  • parent/guardian must be the primary-meal preparing parent/guardian

You may not qualify if:

  • planning to move out of the area in the next 6 months
  • medical condition that would prevent family from participating in group sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota, School of Nursing

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (7)

  • Lee J, Helgeson E, Horning ML, Elgesma KM, Kubik MY, Fulkerson JA. Food Insecurity and Changes in Diet Quality and Body Mass Index z-Scores Among Elementary School Students. Child Obes. 2024 Oct;20(7):508-516. doi: 10.1089/chi.2023.0185. Epub 2024 Mar 28.

  • Horning ML, Friend S, Freese RL, Barr-Anderson DJ, Linde JA, Sidebottom A, Sommerness SA, Fulkerson JA. Parent Weight, Diet, Active Living, and Food-Related Outcomes of the Family-Focused:NU-HOME Randomized Controlled Trial: NU-HOME Randomized Controlled Trial. J Acad Nutr Diet. 2023 May;123(5):751-760.e1. doi: 10.1016/j.jand.2022.10.009. Epub 2022 Oct 13.

  • Linde JA, Horning Dehmer ML, Lee J, Friend S, Flattum C, Arcan C, Fulkerson JA. Associations of parent dietary role modeling with children's diet quality in a rural setting: Baseline data from the NU-HOME study. Appetite. 2022 Jul 1;174:106007. doi: 10.1016/j.appet.2022.106007. Epub 2022 Mar 21.

  • Fulkerson JA, Horning M, Barr-Anderson DJ, Sidebottom A, Linde JA, Lindberg R, Friend S, Beaudette J, Flattum C, Freese RL. Weight outcomes of NU-HOME: a randomized controlled trial to prevent obesity among rural children. Int J Behav Nutr Phys Act. 2022 Mar 19;19(1):29. doi: 10.1186/s12966-022-01260-w.

  • Horning ML, Friend S, Lee J, Flattum C, Fulkerson JA. Family Characteristics Associated with Preparing and Eating More Family Evening Meals at Home. J Acad Nutr Diet. 2022 Jan;122(1):121-128. doi: 10.1016/j.jand.2021.07.002. Epub 2021 Aug 13.

  • Fulkerson JA, Horning ML, Barr-Anderson DJ, Linde JA, Sidebottom AC, Lindberg R, Friend S, Flattum C, Freese RL. Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial. Contemp Clin Trials. 2021 Jan;100:106160. doi: 10.1016/j.cct.2020.106160. Epub 2020 Sep 28.

  • Martin CL, Kramer-Kostecka EN, Linde JA, Friend S, Zuroski VR, Fulkerson JA. Leveraging Interdisciplinary Teams to Develop and Implement Secure Websites for Behavioral Research: Applied Tutorial. J Med Internet Res. 2020 Sep 23;22(9):e19217. doi: 10.2196/19217.

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Jayne A. Fulkerson
Organization
School of Nursing, University of Minnesota

Study Officials

  • Jayne A Fulkerson, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 25, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2020

Study Completion

August 1, 2022

Last Updated

October 7, 2022

Results First Posted

October 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations