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

Physical Activity Clinical Trial

— NU-HOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973815
• Other study ID #: 1509S78583
• Secondary ID: 1R01HL123699
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2022

Study information

• Verified date: September 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: August 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Intake
• Obesity, Childhood
• Pediatric Obesity
• Physical Activity
• Rural Health

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota, School of Nursing	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Allina Health System, Minneapolis Heart Institute Foundation, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Home Availability of Fruits	Participants will report the number of fruits available in their home using the Home Food Inventory.	Post intervention (9 months after baseline)
Secondary	Change in Home Availability of Vegetables	Participants will report the number of vegetables available in their home using the Home Food Inventory.	Post Intervention (9 months after baseline)
Secondary	Change in the Quality of Food and Beverages Served at Family Meals	Participants will report details of food offerings at 7 days of evening meals using the Evening Meal Screener and the quality will be assessed by using a healthfulness score that combines multiple aspects of the meal into a single score. We created the Healthfulness of the Evening Meal Scale which has a range of (-4 to 11) where higher values represent a better outcome.	Post intervention (9 months after baseline)
Secondary	Change in Dietary Intake of Vegetables	Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls	Post intervention (9 months after baseline)
Secondary	Change in Child Dietary Intake of Fruit	Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls	Post intervention (9 months after baseline)
Secondary	Change in Minutes of Child Moderate to Vigorous Physical Activity	Children will wear an accelerometer (ActiGraph wGT3X-BT and GT3XP-BTLE models) for 7 days to measure their activity levels (e.g., minutes of Moderate-to-vigorous physical activity). Trained research staff distributed the monitors to child participants who wore the monitors on their right hip for 7 consecutive days during most waking hours, except when sleeping or doing water-related activities. Data were collected in 10-second epochs. Accelerometer data were analyzed with ActiLife software (version 6.9.1). Non-wear time was defined as any period of >60 minutes of consecutive zeros. To be included in the analyses, participants had to have a minimum of >8 hours of wear time on >3 days. Evenson cutpoints for children were used to classify physical activity intensites: sedentary (0-100), light (101-2295), moderate (2296-4011), and vigorous (>4012). Minutes engaged in Moderate to Vigorous Physical activity was analyzed.	Post intervention (9 months after baseline)
Secondary	Change in Child Screen Time Use	Parents will report on child's daily minutes of screen time.	Post intervention (9 months after baseline)