Food Intake, Obesity, Childhood, Physical Activity, Rural Health
Conditions
Keywords
family meals, home food availability
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.
Interventions
BEHAVIORALNU-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.
Sponsors
Allina Health System
Minneapolis Heart Institute Foundation
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Body Mass Index (BMI) Z-score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Home Availability of Vegetables | Post Intervention (9 months after baseline) | 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 | Post intervention (9 months after baseline) | 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 | Post intervention (9 months after baseline) | Child dietary intake will be assessed using mean number of servings of vegetables from two 24-hour dietary recalls |
| Change in Home Availability of Fruits | Post intervention (9 months after baseline) | Participants will report the number of fruits available in their home using the Home Food Inventory. |
| Change in Minutes of Child Moderate to Vigorous Physical Activity | Post intervention (9 months after baseline) | 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 | Post intervention (9 months after baseline) | Parents will report on child's daily minutes of screen time. |
| Change in Child Dietary Intake of Fruit | Post intervention (9 months after baseline) | Child dietary intake will be assessed using mean number of servings of fruit from two 24-hour dietary recalls |
Countries
United States
Participant flow
Recruitment details
228 participants representing 114 parent/child dyads were recruited in 2 cohorts (summers of 2017 and 2018)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 116 |
| 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. | 112 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up | Lost to Follow-up | 2 | 0 |
| Post Intervention | Death | 1 | 0 |
| Post Intervention | Lost to Follow-up | 7 | 24 |
Baseline characteristics
| Characteristic | Total | NU-HOME Intervention | Delayed Intervention |
|---|---|---|---|
| Age, Customized Child mean age | 9.0 years STANDARD_DEVIATION 1 | 9.0 years STANDARD_DEVIATION 1 | 9.0 years STANDARD_DEVIATION 1.1 |
| Age, Customized Parent mean age | 37.8 years STANDARD_DEVIATION 5.3 | 37.8 years STANDARD_DEVIATION 5 | 37.8 years STANDARD_DEVIATION 5.6 |
| Race/Ethnicity, Customized Child Black, Indigenous, Person of Color | 8 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Child White | 106 Participants | 52 Participants | 54 Participants |
| Race/Ethnicity, Customized Child Hispanic | 8 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Parent Black, Indigenous, Person of Color | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Parent White | 110 Participants | 56 Participants | 54 Participants |
| Race/Ethnicity, Customized Parent Hispanic | 5 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 228 participants | 116 participants | 112 participants |
| Sex/Gender, Customized Child sex Female | 67 Participants | 32 Participants | 35 Participants |
| Sex/Gender, Customized Child sex Male | 47 Participants | 26 Participants | 21 Participants |
| Sex/Gender, Customized Parent sex Female | 111 Participants | 57 Participants | 54 Participants |
| Sex/Gender, Customized Parent sex Male | 3 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 116 | 0 / 112 |
| other Total, other adverse events | 0 / 116 | 0 / 112 |
| serious Total, serious adverse events | 0 / 116 | 0 / 112 |
Outcome results
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.
Time frame: Post intervention (9 months after baseline)
Population: 102 post intervention BMI z-scores
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Child Body Mass Index (BMI) Z-score | 0.69 z-score | Standard Deviation 1 |
| Delayed Intervention | Change in Child Body Mass Index (BMI) Z-score | 1.03 z-score | Standard Deviation 0.89 |
Comparison: This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistancep-value: 0.34295% CI: [-0.194, 0.067]Regression, Linear
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
Time frame: Post intervention (9 months after baseline)
Population: 98 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Child Dietary Intake of Fruit | 0.28 fruits | Standard Deviation 1.41 |
| Delayed Intervention | Change in Child Dietary Intake of Fruit | -0.02 fruits | Standard Deviation 0.95 |
Comparison: Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)p-value: 0.06695% CI: [-0.03, 0.77]Regression, Linear
Secondary
Change in Child Screen Time Use
Parents will report on child's daily minutes of screen time.
Time frame: Post intervention (9 months after baseline)
Population: 98 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Child Screen Time Use | -0.19 minutes | Standard Deviation 0.89 |
| Delayed Intervention | Change in Child Screen Time Use | -0.20 minutes | Standard Deviation 0.93 |
Comparison: Adjusted for: baseline screentime, child age (baseline), and child sexp-value: 0.92895% CI: [-0.31, 0.34]Regression, Linear
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
Time frame: Post intervention (9 months after baseline)
Population: 98 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Dietary Intake of Vegetables | -0.27 vegetables | Standard Deviation 0.94 |
| Delayed Intervention | Change in Dietary Intake of Vegetables | -0.01 vegetables | Standard Deviation 0.69 |
Comparison: Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)p-value: 0.21895% CI: [-0.4, 0.09]Regression, Linear
Secondary
Change in Home Availability of Fruits
Participants will report the number of fruits available in their home using the Home Food Inventory.
Time frame: Post intervention (9 months after baseline)
Population: 94 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Home Availability of Fruits | 1.87 fruits | Standard Deviation 3.62 |
| Delayed Intervention | Change in Home Availability of Fruits | 0.57 fruits | Standard Deviation 4.27 |
Comparison: Adjusted for: baseline HFI Fruit value, and economic assistance statusp-value: 0.0995% CI: [-0.2, 2.71]Regression, Linear
Secondary
Change in Home Availability of Vegetables
Participants will report the number of vegetables available in their home using the Home Food Inventory.
Time frame: Post Intervention (9 months after baseline)
Population: 94 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Home Availability of Vegetables | 0.52 vegetables | Standard Deviation 3.37 |
| Delayed Intervention | Change in Home Availability of Vegetables | -0.76 vegetables | Standard Deviation 2.77 |
Comparison: Adjusted for: baseline HFI Vegetable value, and economic assistance statusp-value: 0.04795% CI: [0.02, 2.44]Regression, Linear
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.
Time frame: Post intervention (9 months after baseline)
Population: 91 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in Minutes of Child Moderate to Vigorous Physical Activity | -1.06 Minutes of physical activity | Standard Deviation 21.47 |
| Delayed Intervention | Change in Minutes of Child Moderate to Vigorous Physical Activity | -1.21 Minutes of physical activity | Standard Deviation 23.01 |
Comparison: Adjusted for: baseline MVPA, child age (baseline), and child sexp-value: 0.2895% CI: [-13.56, 3.98]Regression, Linear
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.
Time frame: Post intervention (9 months after baseline)
Population: 92 change scores analyzed total (takes into account missingness in the predictors variables)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NU-HOME Intervention | Change in the Quality of Food and Beverages Served at Family Meals | 0.18 units on a scale | Standard Deviation 0.96 |
| Delayed Intervention | Change in the Quality of Food and Beverages Served at Family Meals | -0.19 units on a scale | Standard Deviation 1.22 |
Comparison: Adjusted for: baseline healthfulness score and economic assistance statusp-value: 0.01995% CI: [0.08, 0.88]Regression, Linear