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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL123699 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Allina Health System | OTHER |
| Minneapolis Heart Institute Foundation | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NU-HOME Intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Home Availability of Vegetables |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayne A Fulkerson, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, School of Nursing | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38546529 | Derived | 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. | |
| 36244610 | Derived | 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. |
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228 participants representing 114 parent/child dyads were recruited in 2 cohorts (summers of 2017 and 2018)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post Intervention |
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| |||||||||||||||||||||
| Follow-up |
|
114 parent/child dyads
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean age is reported separately for the child participant and the parent participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 102 post intervention BMI z-scores | Posted | Mean | Standard Deviation | z-score | Post intervention (9 months after baseline) |
|
from baseline to post intervention (9 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayne A. Fulkerson | School of Nursing, University of Minnesota | 612-624-4823 | fulke001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2019 | Mar 8, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2017 | Mar 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
Participants will report the number of vegetables available in their home using the Home Food Inventory.
| 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. | 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 | 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 | 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. | Post intervention (9 months after baseline) |
| Change in Child Screen Time Use | Parents will report on child's daily minutes of screen time. | Post intervention (9 months after baseline) |
| 35331787 | Derived | 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. |
| 35305674 | Derived | 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. |
| 34399976 | Derived | 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. |
| 33002598 | Derived | 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. |
| 32965234 | Derived | 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. |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Child and parent data are reported separately | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Parent and child data reported separately | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Parent and child data reported separately | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Change in Home Availability of Fruits | Participants will report the number of fruits available in their home using the Home Food Inventory. | 94 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | fruits | 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. | 94 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | vegetables | 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. | 92 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | units on a scale | 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 | 98 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | vegetables | 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 | 98 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | fruits | 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. | 91 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | Minutes of physical activity | Post intervention (9 months after baseline) |
|
|
|
|
| Secondary | Change in Child Screen Time Use | Parents will report on child's daily minutes of screen time. | 98 change scores analyzed total (takes into account missingness in the predictors variables) | Posted | Mean | Standard Deviation | minutes | Post intervention (9 months after baseline) |
|
|
|
|
| 1 |
| 116 |
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | 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. | 0 | 112 | 0 | 112 | 0 | 112 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Male |
|
| White |
|