Trial Outcomes & Findings for New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME (NCT NCT02973815)
NCT ID: NCT02973815
Last Updated: 2022-10-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
228 participants
Primary outcome timeframe
Post intervention (9 months after baseline)
Results posted on
2022-10-07
Participant Flow
228 participants representing 114 parent/child dyads were recruited in 2 cohorts (summers of 2017 and 2018)
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Post Intervention
STARTED
|
116
|
112
|
|
Post Intervention
COMPLETED
|
108
|
88
|
|
Post Intervention
NOT COMPLETED
|
8
|
24
|
|
Follow-up
STARTED
|
108
|
88
|
|
Follow-up
COMPLETED
|
106
|
88
|
|
Follow-up
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Post Intervention
Death
|
1
|
0
|
|
Post Intervention
Lost to Follow-up
|
7
|
24
|
|
Follow-up
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Child and parent data are reported separately
Baseline characteristics by cohort
| Measure |
NU-HOME Intervention
n=116 Participants
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.
|
Delayed Intervention
n=112 Participants
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.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex/Gender, Customized
Child sex · Female
|
32 Participants
n=58 Participants • Child and parent data are reported separately
|
35 Participants
n=56 Participants • Child and parent data are reported separately
|
67 Participants
n=114 Participants • Child and parent data are reported separately
|
|
Sex/Gender, Customized
Child sex · Male
|
26 Participants
n=58 Participants • Child and parent data are reported separately
|
21 Participants
n=56 Participants • Child and parent data are reported separately
|
47 Participants
n=114 Participants • Child and parent data are reported separately
|
|
Age, Customized
Child mean age
|
9.0 years
STANDARD_DEVIATION 1.0 • n=58 Participants • Mean age is reported separately for the child participant and the parent participant.
|
9.0 years
STANDARD_DEVIATION 1.1 • n=56 Participants • Mean age is reported separately for the child participant and the parent participant.
|
9.0 years
STANDARD_DEVIATION 1.0 • n=114 Participants • Mean age is reported separately for the child participant and the parent participant.
|
|
Age, Customized
Parent mean age
|
37.8 years
STANDARD_DEVIATION 5.0 • n=58 Participants • Mean age is reported separately for the child participant and the parent participant.
|
37.8 years
STANDARD_DEVIATION 5.6 • n=56 Participants • Mean age is reported separately for the child participant and the parent participant.
|
37.8 years
STANDARD_DEVIATION 5.3 • n=114 Participants • Mean age is reported separately for the child participant and the parent participant.
|
|
Sex/Gender, Customized
Parent sex · Female
|
57 Participants
n=58 Participants • Child and parent data are reported separately
|
54 Participants
n=56 Participants • Child and parent data are reported separately
|
111 Participants
n=114 Participants • Child and parent data are reported separately
|
|
Sex/Gender, Customized
Parent sex · Male
|
1 Participants
n=58 Participants • Child and parent data are reported separately
|
2 Participants
n=56 Participants • Child and parent data are reported separately
|
3 Participants
n=114 Participants • Child and parent data are reported separately
|
|
Race/Ethnicity, Customized
Child Hispanic
|
4 Participants
n=58 Participants • Parent and child data reported separately
|
4 Participants
n=56 Participants • Parent and child data reported separately
|
8 Participants
n=114 Participants • Parent and child data reported separately
|
|
Race/Ethnicity, Customized
Parent Hispanic
|
2 Participants
n=58 Participants • Parent and child data reported separately
|
3 Participants
n=56 Participants • Parent and child data reported separately
|
5 Participants
n=114 Participants • Parent and child data reported separately
|
|
Race/Ethnicity, Customized
Child · Black, Indigenous, Person of Color
|
6 Participants
n=58 Participants • Parent and child data reported separately
|
2 Participants
n=56 Participants • Parent and child data reported separately
|
8 Participants
n=114 Participants • Parent and child data reported separately
|
|
Race/Ethnicity, Customized
Child · White
|
52 Participants
n=58 Participants • Parent and child data reported separately
|
54 Participants
n=56 Participants • Parent and child data reported separately
|
106 Participants
n=114 Participants • Parent and child data reported separately
|
|
Race/Ethnicity, Customized
Parent · Black, Indigenous, Person of Color
|
2 Participants
n=58 Participants • Parent and child data reported separately
|
2 Participants
n=56 Participants • Parent and child data reported separately
|
4 Participants
n=114 Participants • Parent and child data reported separately
|
|
Race/Ethnicity, Customized
Parent · White
|
56 Participants
n=58 Participants • Parent and child data reported separately
|
54 Participants
n=56 Participants • Parent and child data reported separately
|
110 Participants
n=114 Participants • Parent and child data reported separately
|
|
Region of Enrollment
United States
|
116 participants
n=116 Participants
|
112 participants
n=112 Participants
|
228 participants
n=228 Participants
|
PRIMARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 102 post intervention BMI z-scores
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.
Outcome measures
| Measure |
NU-HOME Intervention
n=56 Participants
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.
|
Delayed Intervention
n=46 Participants
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.
|
|---|---|---|
|
Change in Child Body Mass Index (BMI) Z-score
|
0.69 z-score
Standard Deviation 1.00
|
1.03 z-score
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 94 change scores analyzed total (takes into account missingness in the predictors variables)
Participants will report the number of fruits available in their home using the Home Food Inventory.
Outcome measures
| Measure |
NU-HOME Intervention
n=52 Participants
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.
|
Delayed Intervention
n=42 Participants
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.
|
|---|---|---|
|
Change in Home Availability of Fruits
|
1.87 fruits
Standard Deviation 3.62
|
0.57 fruits
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: Post Intervention (9 months after baseline)Population: 94 change scores analyzed total (takes into account missingness in the predictors variables)
Participants will report the number of vegetables available in their home using the Home Food Inventory.
Outcome measures
| Measure |
NU-HOME Intervention
n=52 Participants
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.
|
Delayed Intervention
n=42 Participants
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.
|
|---|---|---|
|
Change in Home Availability of Vegetables
|
0.52 vegetables
Standard Deviation 3.37
|
-0.76 vegetables
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 92 change scores analyzed total (takes into account missingness in the predictors variables)
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.
Outcome measures
| Measure |
NU-HOME Intervention
n=49 Participants
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.
|
Delayed Intervention
n=43 Participants
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.
|
|---|---|---|
|
Change in the Quality of Food and Beverages Served at Family Meals
|
0.18 units on a scale
Standard Deviation 0.96
|
-0.19 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 98 change scores analyzed total (takes into account missingness in the predictors variables)
Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls
Outcome measures
| Measure |
NU-HOME Intervention
n=54 Participants
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.
|
Delayed Intervention
n=44 Participants
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.
|
|---|---|---|
|
Change in Dietary Intake of Vegetables
|
-0.27 vegetables
Standard Deviation 0.94
|
-0.01 vegetables
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 98 change scores analyzed total (takes into account missingness in the predictors variables)
Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls
Outcome measures
| Measure |
NU-HOME Intervention
n=54 Participants
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.
|
Delayed Intervention
n=44 Participants
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.
|
|---|---|---|
|
Change in Child Dietary Intake of Fruit
|
0.28 fruits
Standard Deviation 1.41
|
-0.02 fruits
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 91 change scores analyzed total (takes into account missingness in the predictors variables)
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.
Outcome measures
| Measure |
NU-HOME Intervention
n=51 Participants
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.
|
Delayed Intervention
n=40 Participants
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.
|
|---|---|---|
|
Change in Minutes of Child Moderate to Vigorous Physical Activity
|
-1.06 Minutes of physical activity
Standard Deviation 21.47
|
-1.21 Minutes of physical activity
Standard Deviation 23.01
|
SECONDARY outcome
Timeframe: Post intervention (9 months after baseline)Population: 98 change scores analyzed total (takes into account missingness in the predictors variables)
Parents will report on child's daily minutes of screen time.
Outcome measures
| Measure |
NU-HOME Intervention
n=54 Participants
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.
|
Delayed Intervention
n=44 Participants
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.
|
|---|---|---|
|
Change in Child Screen Time Use
|
-0.19 minutes
Standard Deviation 0.89
|
-0.20 minutes
Standard Deviation 0.93
|
Adverse Events
NU-HOME Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jayne A. Fulkerson
School of Nursing, University of Minnesota
Phone: 612-624-4823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place