Clinical trial NCT02973815: New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
Official title: New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Physical Activity
Food Intake
Rural Health
Keywords: family meals
home food availability
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Allina Health System
name: Minneapolis Heart Institute Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-11-25
Enrollment: 228
Sex: ALL
Minimum age (years): 7
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Child Body Mass Index (BMI) Z-score
timeFrame: Post intervention (9 months after baseline)
Secondary outcomes:
measure: Change in Home Availability of Fruits
timeFrame: Post intervention (9 months after baseline)
measure: Change in Home Availability of Vegetables
timeFrame: Post Intervention (9 months after baseline)
measure: Change in the Quality of Food and Beverages Served at Family Meals
timeFrame: Post intervention (9 months after baseline)
measure: Change in Dietary Intake of Vegetables
timeFrame: Post intervention (9 months after baseline)
measure: Change in Child Dietary Intake of Fruit
timeFrame: Post intervention (9 months after baseline)
measure: Change in Minutes of Child Moderate to Vigorous Physical Activity
timeFrame: Post intervention (9 months after baseline)
measure: Change in Child Screen Time Use
timeFrame: Post intervention (9 months after baseline)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Nursing
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jayne A Fulkerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.