Obesity, ChildhoodNU-HOMENCT02973815
New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
A study testing NU-HOME Intervention in people with Obesity, Childhood and Physical Activity, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Physical Activity, Food Intake
- What is being tested?
- NU-HOME Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- planning to move out of the area in the next 6 months
- medical condition that would prevent family from participating in group sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, School of Nursing
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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
- Being tested
- NU-HOME Intervention
- Keywords
- family meals, home food availability
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NU-HOME InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post intervention (9 months after baseline)
Secondary outcomes (7)
Change in Home Availability of Fruits
Participants will report the number of fruits available in their home using the Home Food Inventory.
Measured: Post intervention (9 months after baseline)
Change in Home Availability of Vegetables
Participants will report the number of vegetables available in their home using the Home Food Inventory.
Measured: Post Intervention (9 months after baseline)
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.
Measured: Post intervention (9 months after baseline)
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
Measured: Post intervention (9 months after baseline)
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
Measured: Post intervention (9 months after baseline)
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.
Measured: Post intervention (9 months after baseline)
Change in Child Screen Time Use
Parents will report on child's daily minutes of screen time.
Measured: Post intervention (9 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2020
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System, Minneapolis Heart Institute Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jayne A Fulkerson, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973815
- Sponsor's protocol ID
- 1509S78583
- Other IDs
- 1R01HL123699
- Acronym
- NU-HOME
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2016
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baltaci A, Laska MN, Jiang Z, Lytle LA, Hearst MO, Fulkerson JA. Home Availability of Different Forms of Fruits and Vegetables and Parent/Child Diet by Income: Findings from 4 Studies. J Nutr Educ Behav. 2025 Dec;57(12):1112-1121. doi: 10.1016/j.jneb.2025.07.007. Epub 2025 Sep 1.
PubMed 40888773Lee 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.
PubMed 38546529Horning 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.
PubMed 36244610Linde 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.
PubMed 35331787Fulkerson 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.
PubMed 35305674Horning 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.
PubMed 34399976Fulkerson 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.
PubMed 33002598Martin 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.
PubMed 32965234
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
- ClinicalTrials.gov ID
- NCT02973815
- Acronym / sponsor ID
- NU-HOME / 1509S78583
- Conditions
- Obesity, Childhood, Physical Activity, Food Intake, Rural Health
- Keywords
- family meals, home food availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Allina Health System, Minneapolis Heart Institute Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Posted 7 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NU-HOME Intervention | Experimental | Behavioral: NU-HOME InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 7 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- planning to move out of the area in the next 6 months
- medical condition that would prevent family from participating in group sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NU-HOME InterventionThe 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. | Behavioural | NU-HOME Intervention |
Primary outcome
Change in Child Body Mass Index (BMI) Z-score
Time frame: Post intervention (9 months after baseline)
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.
7 secondary outcomes
Change in Home Availability of Fruits
Time frame: Post intervention (9 months after baseline)
Change in Home Availability of Vegetables
Time frame: Post Intervention (9 months after baseline)
Change in the Quality of Food and Beverages Served at Family Meals
Time frame: Post intervention (9 months after baseline)
Change in Dietary Intake of Vegetables
Time frame: Post intervention (9 months after baseline)
Change in Child Dietary Intake of Fruit
Time frame: Post intervention (9 months after baseline)
Change in Minutes of Child Moderate to Vigorous Physical Activity
Time frame: Post intervention (9 months after baseline)
Change in Child Screen Time Use
Time frame: Post intervention (9 months after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40888773Baltaci A, Laska MN, Jiang Z, Lytle LA, Hearst MO, Fulkerson JA. Home Availability of Different Forms of Fruits and Vegetables and Parent/Child Diet by Income: Findings from 4 Studies. J Nutr Educ Behav. 2025 Dec;57(12):1112-1121. doi: 10.1016/j.jneb.2025.07.007. Epub 2025 Sep 1.
- Derived from this study: PubMed 38546529Lee 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.
- Derived from this study: PubMed 36244610Horning 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.
- Derived from this study: PubMed 35331787Linde 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.
- Derived from this study: PubMed 35305674Fulkerson 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.
- Derived from this study: PubMed 34399976Horning 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.
- Derived from this study: PubMed 33002598Fulkerson 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.
- Derived from this study: PubMed 32965234Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne A Fulkerson, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NU-HOME Intervention in people with Obesity, Childhood and Physical Activity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Body Mass Index (BMI) Z-score (time frame: Post intervention (9 months after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973815, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.