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

Primary Purpose

Obesity, Childhood, Physical Activity, Food Intake

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NU-HOME Intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring family meals, home food availability

Eligibility Criteria

7 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota, School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NU-HOME Intervention

Delayed Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Home Availability of Fruits
Participants will report the number of fruits available in their home using the Home Food Inventory.
Change in Home Availability of Vegetables
Participants will report the number of vegetables available in their home using the Home Food Inventory.
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.
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
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
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.
Change in Child Screen Time Use
Parents will report on child's daily minutes of screen time.

Full Information

First Posted
November 8, 2016
Last Updated
September 11, 2022
Sponsor
University of Minnesota
Collaborators
Allina Health System, Minneapolis Heart Institute Foundation, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02973815
Brief Title
New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
Acronym
NU-HOME
Official Title
New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Allina Health System, Minneapolis Heart Institute Foundation, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Physical Activity, Food Intake, Rural Health
Keywords
family meals, home food availability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NU-HOME Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NU-HOME Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child Body Mass Index (BMI) Z-score
Description
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.
Time Frame
Post intervention (9 months after baseline)
Secondary Outcome Measure Information:
Title
Change in Home Availability of Fruits
Description
Participants will report the number of fruits available in their home using the Home Food Inventory.
Time Frame
Post intervention (9 months after baseline)
Title
Change in Home Availability of Vegetables
Description
Participants will report the number of vegetables available in their home using the Home Food Inventory.
Time Frame
Post Intervention (9 months after baseline)
Title
Change in the Quality of Food and Beverages Served at Family Meals
Description
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.
Time Frame
Post intervention (9 months after baseline)
Title
Change in Dietary Intake of Vegetables
Description
Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls
Time Frame
Post intervention (9 months after baseline)
Title
Change in Child Dietary Intake of Fruit
Description
Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls
Time Frame
Post intervention (9 months after baseline)
Title
Change in Minutes of Child Moderate to Vigorous Physical Activity
Description
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.
Time Frame
Post intervention (9 months after baseline)
Title
Change in Child Screen Time Use
Description
Parents will report on child's daily minutes of screen time.
Time Frame
Post intervention (9 months after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayne A Fulkerson, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, School of Nursing
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35331787
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.
Results Reference
derived
PubMed Identifier
35305674
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.
Results Reference
derived
PubMed Identifier
34399976
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.
Results Reference
derived
PubMed Identifier
33002598
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.
Results Reference
derived
PubMed Identifier
32965234
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.
Results Reference
derived

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

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