New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME

NCT ID: NCT02973815

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2022-08-31

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.

Detailed Description

Childhood obesity is a serious public health problem. Although previous environmental approaches to obesity prevention show some promise, most studies have not shown excess weight gain reductions. Moreover, few childhood obesity prevention studies significantly engage parents or focus on the home environment, which is essential to promote healthy behaviors at home. Children in rural communities are particularly vulnerable regarding increased risk for obesity; thus, successful programs that engage families in rural communities to prevent excess weight gain are critical. The proposed research project, New Ulm at Home (NU-HOME), is a unique collaboration between leaders in a rural community (New Ulm, Minnesota) and successful academic obesity researchers. The residents of New Ulm are poised for and are requesting interventions to promote healthful behavior change, particularly for youth. In conjunction with our many community stakeholder groups, the objective of the proposed research is to test the effectiveness of the NU-HOME program, a 7-month, family-based health promotion intervention to prevent excess weight gain (assessed via BMI z-score) among 7-10 year old children (n=114) in the New Ulm rural community. The intervention program is based on Social Cognitive Theory and a socio-ecological framework and will focus on novel health promotion components to prevent childhood obesity, including: 1) promoting regular meals in which family members cook and eat together (i.e., family meals), 2) promoting nutritionally-sound and appropriately-portioned snacks and meals, 3) reducing sedentary behavior, particularly screen time in the home setting, and 4) promoting physical activity through collaboration with community partners. The NU-HOME study is designed in four stages, including substantial formative work between the academic and community partners, a two-arm randomized controlled trial (RCT; intervention and wait-list control), and two activities to facilitate sustainability (delayed intervention delivery for control group participants and dissemination). A community-based participatory research (CBPR) approach will be used to adapt an existing program, HOME Plus that was piloted and shown to be effective in urban communities. The NU-HOME program has high translation potential and is likely to be immediately useful to rural families of school-age children because it will be tested in a real-world setting in collaboration with engaged, knowledgeable and influential community partners.

Conditions

Obesity, Childhood; Physical Activity; Food Intake; Rural Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NU-HOME Intervention

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.

Group Type: EXPERIMENTAL

NU-HOME Intervention

Intervention Type: BEHAVIORAL

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.

Delayed 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NU-HOME Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allina Health System

OTHER

Sponsor Role: collaborator

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayne A Fulkerson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota, School of Nursing

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38546529 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36244610 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35331787 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35305674 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34399976 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33002598 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32965234 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HL123699

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1509S78583

Identifier Type: -

Identifier Source: org_study_id